DRUP trial

2023-509152-33-00 Protocol M15DRU Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 25 Jul 2016 · Status Ongoing, recruiting · 1 EU/EEA countries · 36 sites · Protocol M15DRU

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 3,000
Countries 1
Sites 36

Advanced solid tumor

1) To describe the anti-tumor activity and toxicity of commercially available, targeted anti-cancer drugs used for treatment of patients with an advanced solid tumor, multiple myeloma, non-Hodgkin lymphoma or T-cell prolymphocytic leukemia that harbors a genomic- or protein expression variant known to be a drug target …

Key facts

Sponsor
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
25 Jul 2016 → ongoing
Decision date (initial)
2024-03-26
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Pfizer · Merck · Janssen · Astra Zeneca · Ipsen Pharma · Stichting Barcode for Life · Roche · Clovis Oncology · Eisai · Bayer Pharma AG · Merck Sharp & Dohme Limited (MSD) · Bristol-Myers Squibb Pharma EEIG (BMS) · Boehringer Ingelheim (BI) · Amgen · Lilly · Hartwig Medical Foundation · Novartis · KWF · Incyte Biosciences

External identifiers

EU CT number
2023-509152-33-00
EudraCT number
2015-004398-33
ClinicalTrials.gov
NCT02925234

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

1) To describe the anti-tumor activity and toxicity of commercially available, targeted anti-cancer drugs used for treatment of patients with an advanced solid tumor, multiple myeloma, non-Hodgkin lymphoma or T-cell prolymphocytic leukemia that harbors a genomic- or protein expression variant known to be a drug target or to predict sensitivity to a drug.
2) To facilitate patient access to commercially available, targeted anti-cancer drugs of potential efficacy for treatment of an advanced solid tumor, multiple myeloma, non-Hodgkin lymphoma or T-cell prolymphocytic leukemia that harbors a genomic or protein expression variant known to be a drug target or to predict sensitivity to a drug.

Secondary objectives 1

  1. To perform biomarker analyses, including (but not limited to) next generation sequencing on a fresh tumor biopsy specimen.

Conditions and MedDRA coding

Advanced solid tumor

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

  1. Adult (age >18 years) patient with a histologically-proven locally advanced or metastatic solid tumor, multiple myeloma, non-Hodgkin lymphoma or T-cell prolymphocytic leukemia with symptomatic or radiological disease progression after standard anti-cancer treatment or for whom no such treatment is available or indicated. For patients with a primary brain tumor: Histologically confirmed recurrent or de novo primary brain tumor, with unequivocal progression after prior therapy, at least 3 months after radiotherapy (either first line chemo-radiotherapy or re-irradiation), and with stable or decreasing dosage of steroids for at least 7 days prior to the baseline MRI scan.
  2. ECOG performance status 0-2
  3. Patients must have acceptable organ function as defined below. However, specific inclusion/exclusion criteria specified in the drug-specific study manual will take precedence: a. Absolute neutrophil count ≥ 1.5 x 109/l b. Hemoglobin > 5.6 mmol/l c. Platelets > 75 x 109/l d. Total bilirubin < 2 x ULN e. AST (SGOT) and ALT (SGPT) < 2.5 x institutional ULN (or < 5 x ULN in patients with known hepatic metastases) f. Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2
  4. Patients must have objectively measurable disease (by physical or radiographic examination, according to RECIST v1.1 for patients with solid tumors, or according to IMWG, Lugano, RANO or GCIG criteria, resp., for patients with multiple myeloma, non-Hodgkin lymphoma, and T-cell prolymphocytic leukemia, primary brain tumors or ovarian cancer in case of CA125-based evaluation
  5. Results must be available from a tumor genomic or protein expression test. Eligible tests may include any of the following technologies: fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), comparative genomic hybridization (CGH), next generation sequencing (NGS), immunohistochemistry (IHC) or RNA sequencing (RNAseq). The test may have been performed on the primary tumor or a metastatic deposit, in a diagnostic laboratory or within the context of another CPCT study, and must reveal a potentially actionable variant as defined in Section 5. The test results (full pathology or molecular diagnostics report) must be uploaded in the eCRF.
  6. Patients must have a tumor profile for which treatment with one of the FDA and / or EMA approved (or under revision for approval) targeted anti-cancer drugs included in this study has potential clinical benefit based on preclinical data or clinical information
  7. A new (obtained ≤2 months before inclusion, and without any type of anti-cancer therapy within those ≤2 months) fresh frozen tumor biopsy specimen for extensive biomarker testing is mandatory before the start of treatment with a targeted agent included in the protocol. Alternatively, fresh frozen tumor tissue acquired in the context of a standard care procedure may be used, provided that no systemic anti-cancer treatment was given between the procedure and start of study treatment within DRUP. Exceptions are made for: a) patients with a primary brain tumor or other tumor types with only intracerebral lesions, only if the mandatory DRUP pre-treatment biopsy for biomarker analysis cannot safely be obtained; b) In case WGS is performed on tumor tissue outside the context of a clinical trial before inclusion, and without any type of anti-cancer therapy between the collection of tissue and inclusion in DRUP, this can replace the DRUP pre-treatment biopsy; c) patients that underwent an allogeneic hematopoietic stem cell transplantation prior to study enrollment, since this will prevent a correct WGS analysis due to a mismatch between the biopsy specimen and the required blood sample
  8. Ability to understand and the willingness to sign a written informed consent document
  9. For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
  10. Because of the risks of drug treatment to the developing foetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Male patients should avoid impregnating a female partner. Male patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or completely abstain from sexual intercourse.

Exclusion criteria 8

  1. Ongoing toxicity > grade 2, other than alopecia or grade 2 peripheral neuropathy.
  2. Patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement). Required wash out period prior to starting study treatment is at least two weeks. An exception is made for patients suffering from CRPC are allowed to continue androgen deprivation therapy
  3. Patient is pregnant or nursing
  4. Patients with brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to registration. All patients with previously treated brain metastases must be stable for at least 1 month after completion of treatment and off steroid treatment prior to study enrollment. Specific exclusion criteria for patients with primary brain tumors: a. Patients who require anti-convulsant therapy must be taking non-enzyme inducing antiepileptic drugs (non-EIAED). EIAED are prohibited. Patients previously on EIAED must be switched to non-EIAED at least 2 weeks prior to randomization. b. No radiotherapy within the three months prior to the diagnosis of progression. c. No radiotherapy with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven.
  5. Patients with clinically significant preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure
  6. Patients with known left ventricular ejection fraction (LVEF) < 40%
  7. Patients with stroke (including TIA) or acute myocardial infarction within 3 months before the first dose of study treatment
  8. Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

  1. Percentage of patients that are treated based on their molecular tumor profile
  2. Objective tumor response
  3. Disease control, defined as Stable Disease (SD) at 16 weeks after treatment initiation
  4. Treatment-related grade≥3 and serious adverse events

Secondary endpoints 2

  1. Progression-free and overall survival
  2. Duration of treatment on study (time on drug)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 63

Piqray 50 mg and 200 mg film-coated tablets

PRD8235746 · Product

Active substance
Alpelisib
Substance synonyms
(2S)-N1-(4-METHYL-5-(1-(1,1,1-TRIFLUORO-2-METHYLPROPAN-2-YL)PYRIDIN-4-YL)-1,3-THIAZOL-2-YL)PYRROLIDINE-1,2-DICARBOXAMIDE, BYL719
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EM03 — -
Marketing authorisation
EU/1/20/1455/006
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piqray 150 mg film-coated tablets

PRD8234902 · Product

Active substance
Alpelisib
Substance synonyms
(2S)-N1-(4-METHYL-5-(1-(1,1,1-TRIFLUORO-2-METHYLPROPAN-2-YL)PYRIDIN-4-YL)-1,3-THIAZOL-2-YL)PYRROLIDINE-1,2-DICARBOXAMIDE, BYL719
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EM03 — -
Marketing authorisation
EU/1/20/1455/003
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rubraca 200 mg film-coated tablets

PRD10480579 · Product

Active substance
Rucaparib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1200 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XK03 — -
Marketing authorisation
EU/1/17/1250/001
MA holder
PHARMAAND GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rubraca 250 mg film-coated tablets

PRD10480795 · Product

Active substance
Rucaparib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1200 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XK03 — -
Marketing authorisation
EU/1/17/1250/002
MA holder
PHARMAAND GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rubraca 300 mg film-coated tablets

PRD10480798 · Product

Active substance
Rucaparib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1200 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XK03 — -
Marketing authorisation
EU/1/17/1250/003
MA holder
PHARMAAND GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Verzenios 50 mg film-coated tablets

PRD6841633 · Product

Active substance
Abemaciclib
Substance synonyms
LY2835219
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
400 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EF03 — -
Marketing authorisation
EU/1/18/1307/017
MA holder
ELI LILLY NEDERLAND B.V.
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Different primary packaging (bottles) than in marketing authorisation and clinical trial specific packaging and labeling

Herceptin 150 mg powder for concentrate for solution for infusion

PRD389605 · Product

Active substance
Trastuzumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
8 mg/Kg milligram(s)/kilogram
Max total dose
99999 mg/Kg milligram(s)/kilogram
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XC03 — TRASTUZUMAB
Marketing authorisation
EU/1/00/145/001
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Perjeta 420 mg concentrate for solution for infusion

PRD801541 · Product

Active substance
Pertuzumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
840 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XC13 — -
Marketing authorisation
EU/1/13/813/001
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tafinlar 75 mg hard capsules

PRD4300053 · Product

Active substance
Dabrafenib
Substance synonyms
GSK2118436
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EC02 — -
Marketing authorisation
EU/1/13/865/004
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tafinlar 50 mg hard capsules

PRD4300051 · Product

Active substance
Dabrafenib
Substance synonyms
GSK2118436
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EC02 — -
Marketing authorisation
EU/1/13/865/002
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Inlyta 1 mg film-coated tablets

PRD6541011 · Product

Active substance
Axitinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
20 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EK01 — -
Marketing authorisation
EU/1/12/777/002
MA holder
PFIZER EUROPE MA EEIG
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Inlyta 5 mg film-coated tablets

PRD6541013 · Product

Active substance
Axitinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
20 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EK01 — -
Marketing authorisation
EU/1/12/777/006
MA holder
PFIZER EUROPE MA EEIG
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tasigna 150 mg hard capsules

PRD4299857 · Product

Active substance
Nilotinib
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
800 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EA03 — -
Marketing authorisation
EU/1/07/422/013
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tasigna 200 mg hard capsules

PRD4299866 · Product

Active substance
Nilotinib
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
800 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EA03 — -
Marketing authorisation
EU/1/07/422/014
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cotellic 20 mg film-coated tablets

PRD3442533 · Product

Active substance
Cobimetinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
60 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EE02 — -
Marketing authorisation
EU/1/15/1048/001
MA holder
ROCHE REGISTRATION GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tibsovo 250 mg film-coated tablets

PRD10400337 · Product

Active substance
Ivosidenib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
500 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XX62 — -
Marketing authorisation
EU/1/23/1728/001
MA holder
LES LABORATOIRES SERVIER (SURESNES)
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sutent 25 mg hard capsules

PRD505838 · Product

Active substance
Sunitinib
Substance synonyms
N-(2-(DIETHYLAMINO)ETHYL)-5-((Z)-(5-FLUORO-2-OXO-1,2-DIHYDRO-3H-INDOL-3-YLIDENE)METHYL)-2,4-DIMETHYL-1H-PYRROLE-3-CARBOXAMIDE, SU-011,248
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
50 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EX01 — -
Marketing authorisation
EU/1/06/347/005
MA holder
PFIZER EUROPE MA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sutent 12.5 mg hard capsules

PRD505881 · Product

Active substance
Sunitinib
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
50 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EX01 — -
Marketing authorisation
EU/1/06/347/004
MA holder
PFIZER EUROPE MA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Erivedge 150 mg hard capsules

PRD921910 · Product

Active substance
Vismodegib
Substance synonyms
GDC-0449, RO5450815
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
150 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XJ01 — -
Marketing authorisation
EU/1/13/848/001
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

YERVOY 5 mg/ml concentrate for solution for infusion

PRD363755 · Product

Active substance
Ipilimumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1 mg/Kg milligram(s)/kilogram
Max total dose
4 mg/Kg milligram(s)/kilogram
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01FX04 — -
Marketing authorisation
EU/1/11/698/001
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

YERVOY 5 mg/ml concentrate for solution for infusion

PRD363872 · Product

Active substance
Ipilimumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1 mg/Kg milligram(s)/kilogram
Max total dose
4 mg/Kg milligram(s)/kilogram
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01FX04 — -
Marketing authorisation
EU/1/11/698/002
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vectibix 20 mg/ml concentrate for solution for infusion

PRD526654 · Product

Active substance
Panitumumab
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
ORAL
Max daily dose
6 mg/Kg milligram(s)/kilogram
Max total dose
99999 mg/Kg milligram(s)/kilogram
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XC08 — -
Marketing authorisation
EU/1/07/423/003
MA holder
AMGEN EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lynparza 100 mg film-coated tablets

PRD6165304 · Product

Active substance
Olaparib
Substance synonyms
AZD-2281, AZD2281
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
600 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XX46 — -
Marketing authorisation
EU/1/14/959/002
MA holder
ASTRAZENECA AB
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Different primary packaging (bottles) and number of tablets per bottle (32) than in marketing authorisation. The commercial Lynparza film-coated tablet is identical to the olaparib film-coated tablet (IMP) except that that it has a yellow film coat due to the deletion of a small amount of black iron oxide, and has a commercial deboss/marking. The IMP has a green film coat, is unmarked and packed in HDPE bottles rather than the commercial blister pack to facilitate blinding in placebo controlled studies.

Lynparza 150 mg film-coated tablets

PRD6152518 · Product

Active substance
Olaparib
Substance synonyms
AZD-2281, AZD2281
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
600 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XX46 — -
Marketing authorisation
EU/1/14/959/004
MA holder
ASTRAZENECA AB
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/07/501
Modified vs. Marketing Authorisation
Yes
Modification description
Different primary packaging (bottles) and number of tablets per bottle (32) than in marketing authorisation. The commercial Lynparza film-coated tablet is identical to the olaparib film-coated tablet (IMP) except that that it has a yellow film coat due to the deletion of a small amount of black iron oxide, and has a commercial deboss/marking. The IMP has a green film coat, is unmarked and packed in HDPE bottles rather than the commercial blister pack to facilitate blinding in placebo controlled studies.

IMFINZI 50 mg/mL concentrate for solution for infusion.

PRD6651663 · Product

Active substance
Durvalumab
Substance synonyms
MEDI4736
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1500 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XC28 — -
Marketing authorisation
EU/1/18/1322/002
MA holder
ASTRAZENECA AB
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemazyre 4.5 mg tablets

PRD8840299 · Product

Active substance
Pemigatinib
Substance synonyms
INCB054828, FGFR INHIBITOR INCB054828
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
13.5 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EN02 — -
Marketing authorisation
EU/1/21/1535/002
MA holder
INCYTE BIOSCIENCES DISTRIBUTION B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/18/2066
Modified vs. Marketing Authorisation
Yes
Modification description
Provided in bottles in stead of blisters

Alecensa 150 mg hard capsules

PRD5956678 · Product

Active substance
Alectinib
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
1200 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01ED03 — -
Marketing authorisation
EU/1/16/1169/002
MA holder
ROCHE REGISTRATION GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Retsevmo 40 mg hard capsules

PRD9032341 · Product

Active substance
Selpercatinib
Substance synonyms
6-(2-HYDROXY-2-METHYLPROPOXY)-4-(6-(6-((6-METHOXYPYRIDIN-3-YL)METHYL)-3,6-DIAZABICYCLO[3.1.1]HEPTAN-3-YL)PYRIDIN-3-YL)PYRAZOLO[1,5-A]PYRIDINE-3-CARBONITRILE, LOXO-292
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
320 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EX22 — -
Marketing authorisation
EU/1/20/1527/007
MA holder
ELI LILLY NEDERLAND B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Retsevmo 80 mg hard capsules

PRD9032344 · Product

Active substance
Selpercatinib
Substance synonyms
6-(2-HYDROXY-2-METHYLPROPOXY)-4-(6-(6-((6-METHOXYPYRIDIN-3-YL)METHYL)-3,6-DIAZABICYCLO[3.1.1]HEPTAN-3-YL)PYRIDIN-3-YL)PYRAZOLO[1,5-A]PYRIDINE-3-CARBONITRILE, LOXO-292
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
320 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EX22 — -
Marketing authorisation
EU/1/20/1527/011
MA holder
ELI LILLY NEDERLAND B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Mekinist 0.5 mg film-coated tablets

PRD4361605 · Product

Active substance
Trametinib
Substance synonyms
GSK1120212B
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
2 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EE01 — -
Marketing authorisation
EU/1/14/931/002
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Mekinist 2 mg film-coated tablets

PRD4361607 · Product

Active substance
Trametinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
2 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EE01 — -
Marketing authorisation
EU/1/14/931/006
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

KEYTRUDA 25 mg/mL concentrate for solution for infusion

PRD4323786 · Product

Active substance
Pembrolizumab
Substance synonyms
Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, ABP 234
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
200 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01FF02 — -
Marketing authorisation
EU/1/15/1024/002
MA holder
MERCK SHARP & DOHME B.V.
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lorviqua 25 mg film-coated tablets

PRD7500795 · Product

Active substance
Lorlatinib
Substance synonyms
PF-06463922
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
100 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01ED05 — -
Marketing authorisation
EU/1/19/1355/003
MA holder
PFIZER EUROPE MA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lorviqua 100 mg film-coated tablets

PRD7271630 · Product

Active substance
Lorlatinib
Substance synonyms
PF-06463922
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
100 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01ED05 — -
Marketing authorisation
EU/1/19/1355/002
MA holder
PFIZER EUROPE MA EEIG
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Zelboraf 240 mg film-coated tablets

PRD366907 · Product

Active substance
Vemurafenib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1920 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EC01 — -
Marketing authorisation
EU/1/12/751/001
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Zejula 100 mg hard capsules

PRD7912570 · Product

Active substance
Niraparib Tosilate Monohydrate
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XK02 — -
Marketing authorisation
EU/1/17/1235/001
MA holder
GLAXOSMITHKLINE (IRELAND) LIMITED
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Different primary packaging (bottles) than in marketing authorisation

Stivarga 40 mg film-coated tablets

PRD3438601 · Product

Active substance
Regorafenib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
160 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XE21 — -
Marketing authorisation
EU/1/13/858/001
MA holder
BAYER AG
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

CABOMETYX 20 mg film-coated tablets

PRD4382804 · Product

Active substance
Cabozantinib
Substance synonyms
XL-184, Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
60 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EX07 — -
Marketing authorisation
EU/1/16/1136/002
MA holder
IPSEN PHARMA
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

CABOMETYX 60 mg film-coated tablets

PRD4383121 · Product

Active substance
Cabozantinib
Substance synonyms
XL-184, Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
60 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EX07 — -
Marketing authorisation
EU/1/16/1136/006
MA holder
IPSEN PHARMA
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

JNJ-42756493

PRD4429388 · Product

Active substance
Erdafitinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
9 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

JNJ-42756493

PRD4429392 · Product

Active substance
Erdafitinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
9 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

JNJ-42756493

PRD4429389 · Product

Active substance
Erdafitinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
9 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Rozlytrek 200 mg hard capsules

PRD8236755 · Product

Active substance
Entrectinib
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
600 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EX14 — -
Marketing authorisation
EU/1/20/1460/002
MA holder
ROCHE REGISTRATION GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rozlytrek 100 mg hard capsules

PRD8236784 · Product

Active substance
Entrectinib
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
600 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EX14 — -
Marketing authorisation
EU/1/20/1460/001
MA holder
ROCHE REGISTRATION GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

XALKORI 250 mg hard capsules

PRD672299 · Product

Active substance
Crizotinib
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
500 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01ED01 — -
Marketing authorisation
EU/1/12/793/003
MA holder
PFIZER EUROPE MA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

XALKORI 200 mg hard capsules

PRD672298 · Product

Active substance
Crizotinib
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
500 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01ED01 — -
Marketing authorisation
EU/1/12/793/001
MA holder
PFIZER EUROPE MA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vizimpro 30 mg film-coated tablets

PRD7214105 · Product

Active substance
Dacomitinib
Substance synonyms
PF-00299804
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
45 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EB07 — -
Marketing authorisation
EU/1/19/1354/002
MA holder
PFIZER EUROPE MA EEIG
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vizimpro 45 mg film-coated tablets

PRD7214113 · Product

Active substance
Dacomitinib
Substance synonyms
PF-00299804
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
45 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EB07 — -
Marketing authorisation
EU/1/19/1354/003
MA holder
PFIZER EUROPE MA EEIG
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vizimpro 15 mg film-coated tablets

PRD7214093 · Product

Active substance
Dacomitinib
Substance synonyms
PF-00299804
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
45 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EB07 — -
Marketing authorisation
EU/1/19/1354/001
MA holder
PFIZER EUROPE MA EEIG
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Talzenna 1 mg hard capsules

PRD7388909 · Product

Active substance
Talazoparib
Substance synonyms
BMN 673
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
1 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XK04 — -
Marketing authorisation
EU/1/19/1377/005
MA holder
PFIZER EUROPE MA EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Talzenna 0.25 mg hard capsules

PRD7388911 · Product

Active substance
Talazoparib
Substance synonyms
BMN 673
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
1 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XK04 — -
Marketing authorisation
EU/1/19/1377/003
MA holder
PFIZER EUROPE MA EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

TEPMETKO 225 mg film-coated tablets

PRD9570287 · Product

Active substance
Tepotinib
Substance synonyms
EMD-1214063, 3-{1-[(3-{5-[(1-methylpiperidin-4-yl)methoxy]pyrimidin-2-yl}phenyl)methyl]-6-oxo-1,6-dihydropyridazin-3-yl}benzonitrile, MSC-2156119J
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
450 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EX21 — -
Marketing authorisation
EU/1/21/1596/001
MA holder
MERCK EUROPE B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

LENVIMA 4 mg hard capsules

PRD7660544 · Product

Active substance
Lenvatinib
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
24 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EX08 — -
Marketing authorisation
EU/1/15/1002/004
MA holder
EISAI GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Clinical drug is in a plain white HDPE bottle, labelled with a clinical label. Also, the clinical drug does not have any markings on the capsules

LENVIMA 10 mg hard capsules

PRD7660552 · Product

Active substance
Lenvatinib
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
24 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EX08 — -
Marketing authorisation
EU/1/15/1002/006
MA holder
EISAI GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Clinical drug is in a plain white HDPE bottle, labelled with a clinical label. Also, the clinical drug does not have any markings on the capsules

OPDIVO 10 mg/mL concentrate for solution for infusion.

PRD9754393 · Product

Active substance
Nivolumab
Substance synonyms
BMS936558, ABP 206
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
480 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01FF01 — -
Marketing authorisation
EU/1/15/1014/004
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Avastin 25 mg/ml concentrate for solution for infusion.

PRD389578 · Product

Active substance
Bevacizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
15 mg/Kg milligram(s)/kilogram
Max total dose
99999 mg/Kg milligram(s)/kilogram
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01FG01 — -
Marketing authorisation
EU/1/04/300/001
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Avastin 25 mg/ml concentrate for solution for infusion.

PRD389577 · Product

Active substance
Bevacizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
15 mg/Kg milligram(s)/kilogram
Max total dose
99999 mg/kg milligram(s)/kilogram
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01FG01 — -
Marketing authorisation
EU/1/04/300/002
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tecentriq 1 200 mg concentrate for solution for infusion

PRD5434943 · Product

Active substance
Atezolizumab
Substance synonyms
RO5541267
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1200 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01FF05 — -
Marketing authorisation
EU/1/17/1220/001
MA holder
ROCHE REGISTRATION GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tarceva 100 mg film-coated tablets

PRD366726 · Product

Active substance
Erlotinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
150 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EB02 — -
Marketing authorisation
EU/1/05/311/002
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tarceva 25 mg film-coated tablets

PRD366728 · Product

Active substance
Erlotinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
150 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EB02 — -
Marketing authorisation
EU/1/05/311/001
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tarceva 150 mg film-coated tablets

PRD366727 · Product

Active substance
Erlotinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
150 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01EB02 — -
Marketing authorisation
EU/1/05/311/003
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Zejula 100 mg film-coated tablets

PRD9709366 · Product

Active substance
Niraparib Tosilate Monohydrate
Substance synonyms
NIRAPARIB TOSYLATE MONOHYDRATE, MK-4827 TOSYLATE MONOHYDRATE, (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Authorised
ATC code
L01XK02 — -
Marketing authorisation
EU/1/17/1235/004
MA holder
GLAXOSMITHKLINE (IRELAND) LIMITED
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Different primary packaging (bottles) than in marketing authorisation

JNJ-61186372

PRD11078981 · Product

Active substance
Amivantamab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
2240 mg milligram(s)
Max total dose
99999 mg milligram(s)
Max treatment duration
999 Month(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

45 Total trials 26 Recruiting 13 Ended
Academic / Non-commercial
Sponsor organisation
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Address
Plesmanlaan 121
City
Amsterdam
Postcode
1066 CX
Country
Netherlands

Scientific contact point

Organisation
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Contact name
Prof. dr. E.E. Voest

Public contact point

Organisation
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Contact name
Prof. dr. E.E. Voest

Locations

1 EU/EEA country · 36 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ongoing, recruiting 3,000 36
Rest of world — 0 —

Investigational sites

Netherlands

36 sites · Ongoing, recruiting
Maxima Medisch Centrum
Internal medicine, Ds Theodor Fliednerstraat 1, 5631 BM, Eindhoven
Isala Klinieken Stichting
Isala Oncology Center, Dokter Van Heesweg 2, 8025 AB, Zwolle
Amphia Hospital
Internal Medicine, Molengracht 21, 4818 CK, Breda
Sint Franciscus Vlietland Groep Stichting
Internal medicine, Vlietlandplein 2, 3118 JH, Schiedam
Ziekenhuisgroep Twente Stichting
Internal Medicine and Gastrointestinal liver disease, Zilvermeeuw 1, 7609 PP, Almelo
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Gelre Hospitals
Interne geneeskunde, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn
Treant Ziekenhuiszorg Stichting
Interne-oncologie, Dr G H Amshoffweg 1, 7909 AA, Hoogeveen
Tergooiziekenhuizen
Interne geneeskunde, Van Riebeeckweg 212, 1213 XZ, Hilversum
Stichting Radboud universitair medisch centrum
Medical Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Deventer Ziekenhuis
Internal medicine, Nico Bolkesteinlaan 75, 7416 SE, Deventer
Universitair Medisch Centrum Groningen
Medical Oncology, Hanzeplein 1, 9713 GZ, Groningen
Beatrix Ziekenhuis
Interne oncologie, Banneweg 57, 4204 AA, Gorinchem
Leids Universitair Medisch Centrum (LUMC)
Klinische oncologie, Albinusdreef 2, 2333 ZA, Leiden
Meander Medisch Centrum Stichting
Medical Oncology, Maatweg 3, 3813 TZ, Amersfoort
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Molecular Oncology and Immunology, Plesmanlaan 121, 1066 CX, Amsterdam
Academisch Medisch Centrum
Oncology, Meibergdreef 9, 1105 AZ, Amsterdam
Universitair Medisch Centrum Utrecht
Medical Oncology, Heidelberglaan 100, 3584 CX, Utrecht
Spaarne Gasthuis Stichting
Interne geneeskunde, Spaarnepoort 1, 2134 TM, Hoofddorp
Bravis Ziekenhuis
Interne geneeskunde, Boerhaavelaan 25, 4708 AE, Roosendaal
St. Elisabeth Hospital Tilburg
Interne geneeskunde, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Amsterdam UMC Stichting
Medical Oncology, De Boelelaan 1117, 1081 HV, Amsterdam
Zuyderland Medisch Centrum Stichting
Internal Medicine/Oncology, Henri Dunantstraat 5, 6419 PC, Heerlen
St. Antonius Ziekenhuis
Interne geneeskunde, Medische Oncologie, Soestwetering 1, 3543 AZ, Utrecht
OLVG Stichting
Medical Oncology, Oosterpark 9, 1091 AC, Amsterdam
Stichting Martini Ziekenhuis
Internal medicine, Van Swietenplein 1, 9728 NT, Groningen
Medical Center Haaglanden
Interne oncologie, Burgemeester Banninglaan 1, 2262 BA, Leidschendam
Haga Hospital
Interne Geneeskunde/oncologie, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Internal Oncology, Tegelseweg 210, 5912 BL, Venlo
Rijnstate Ziekenhuis Stichting
Medical Oncology, Wagnerlaan 55, 6815 AD, Arnhem
Ziekenhuis Gelderse Vallei Stichting
Interne geneeskunde, Willy Brandtlaan 10, 6716 RP, Ede Gld
Noordwest Ziekenhuisgroep Stichting
Medical Oncology, Wilhelminalaan 12, 1815 JD, Alkmaar
Medisch Centrum Leeuwarden B.V.
Oncologie, Henri Dunantweg 2, 8934 AD, Leeuwarden
University Hospital Maastricht
Medical Oncology, P Debyelaan 25, 6229 HX, Maastricht
Reinier de Graaf Groep
Interne geneeskunde, Reinier De Graafweg 5, 2625 AD, Delft
Ziekenhuis Nij Smellinghe
Internal Medicine/Hemato-Oncology, Compagnonsplein 1, 9202 NN, Drachten

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Netherlands 2016-07-25 2016-08-19

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 1 · Art. 52 CTR

Serious breach SB-105423

Sponsor became aware
2025-11-03
Date of breach
2025-09-16
Submission date
2026-02-04
Member states concerned
Netherlands
Categories
Protocol
Areas impacted
Data reliability or robustness
Benefit-risk balance changed
Yes
Description
Description of the serious breach: Patient has mistakenly used pemigatinib 4.5 mg daily during the first 2 treatment cycles instead of 13.5 mg. Patient has received all treatment related information explaining the correct dose of study medication and the label on the medication packages also states the right dose. Patient however doubted if he should take 1 or 3 tablets daily and called the hospital to ask. We do not know who he spoke to (patient doesn&#39;t recall, no member of study team or pharmacy recalls receiving this question), but patient says he was told to use 1 tablet daily (4.5 mg) and so he did, despite all written study information stating 13.5 mg daily.
During the check-up prior to cycle 3, on 31-10-2025, patient informed me that he still has a lot of tablets left, and it turned out he had been using the wrong dose.

Impact: assessment of response is expected on 11-11-2025. If the patiënt has response, a very limited impact on the trial is expected. If no response is observed, it is unclear if patient is primary resistant to treatment, or if non-response is due to unintended under-dosing.

Update dd 13-NOV-2025:
Response evaluation dd 11NOV showed stable disease according to RECIST.

Update dd 02-DEC-2025:
The first respons evaluation showed stable disease compared to the baseline scan. The target lesion, a liver metastasis, remained unchanged. The non-target lesions, known enlarged lymph nodes in the hilar region and upper abdomen, also showed no change. A nodule in the right lower lobe of the lung showed a slight 2mm growth; however, this remains within acceptable limits. No new lesions were identified.
Sponsor actions
Patient was informed about the correct dose on 31-10-2025 and has confirmed that he will take the correct dose of 13.5 mg daily from that moment on. We have scheduled extra checkup appointments to make sure he takes the right dose en to check for new AE&#39;s.

Update dd 02-DEC-2025:
At the trial site, extensive efforts to correctly inform patients about their study treatment are already in place since start of the trial. Patients are informed about the trial medication verbally by the treating physician (for referred patients like the patient involved in the serious breach, this is only done by a select number of oncologists to ensure high-level knowledge of the protocol and drugs), they are informed in writing using the DRUP patient information, which is handed out by the treating physician, and also they are informed about all study procedures and ways to contact the study team by the trial nurses, verbally and in writing. Additionally, patients receive verbal and written information about the study drug by the study pharmacist when handing out the trial medication.
As it is unclear who the patient spoke to when he called the hospital (and even, whether he called the hospital at all), it is difficult to pinpoint which part of the process of informing patients needs extra attention. For that reason, we have asked the oncologists and trial nurses involved in the trial to put extra emphasis on the exact study medication dose, and on the contact information during the study visits, starting at the screening visit and continuously during follow-up visits.
We are happy to see that the patient has stable disease at first response evaluation and that he is allowed to continue his study participation. We have had extra follow-up appointments with the patient to check for toxicity after starting the correct dose (besides constipation he has none). We see his serum phosphate level rising little by little, supporting his medication adherence. We hope to have provided sufficient information for the ad hoc assessment of this serious breach and are convinced that we have taken all possible actions and precautions to prevent recurrence of this type of miscommunication.

Update 02-FEB-2026:
The drug specific appendix to the subject information letter contains the text from the package leaflet in the SmPC. It was only found out now that this text (under 3. How to take Pemazyre) refers to a recommended dose of &#34;1 tablet of Pemazyre 13.5 mg&#34;.
We have amended the text in the appendix to &#34;3 tablets of Pamazyre 4.5 mg&#34;, see attached.
We consider the amended document as a non-substantial modification, as the total recommended dose is not changed. We will submit this with our next substantial modification, which is expected in May, but the document will be implemented for use immediately.
OrganisationCityCountryType
University Hospital Maastricht Maastricht Netherlands Clinical investigator

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 144 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Drug specific manual Abemaciclib 5
Protocol (for publication) D1_Drug specific manual Alectinib 4
Protocol (for publication) D1_Drug specific manual Alpelisib 5
Protocol (for publication) D1_Drug specific manual Amivantamab 1
Protocol (for publication) D1_Drug specific manual Atezolizumab_Bevacizumab 4
Protocol (for publication) D1_Drug specific manual Axitinib 14
Protocol (for publication) D1_Drug specific manual Cabozantinib 6
Protocol (for publication) D1_Drug specific manual Crizotinib 15
Protocol (for publication) D1_Drug specific manual Dabrafenib mono 12
Protocol (for publication) D1_Drug specific manual Dabrafenib_Trametinib 16
Protocol (for publication) D1_Drug specific manual Dacomitinib 5
Protocol (for publication) D1_Drug specific manual Durvalumab 9
Protocol (for publication) D1_Drug specific manual Entrectinib 4
Protocol (for publication) D1_Drug specific manual Erdafitinib 5
Protocol (for publication) D1_Drug specific manual Erlotinib 12
Protocol (for publication) D1_Drug specific manual Ivosidenib 1
Protocol (for publication) D1_Drug specific manual Lenvatinib 12
Protocol (for publication) D1_Drug specific manual Lorlatinib 5
Protocol (for publication) D1_Drug specific manual Nilotinib 13
Protocol (for publication) D1_Drug specific manual Niraparib 6
Protocol (for publication) D1_Drug specific manual Nivolumab 16
Protocol (for publication) D1_Drug specific manual Nivolumab stage III 9
Protocol (for publication) D1_Drug specific manual Nivolumab_Ipilimumab 6
Protocol (for publication) D1_Drug specific manual Olaparib 16
Protocol (for publication) D1_Drug Specific Manual Olaparib 3rd stage 2
Protocol (for publication) D1_Drug Specific Manual Olaparib 3rd stage_TC 2
Protocol (for publication) D1_Drug specific manual Panitumumab 17
Protocol (for publication) D1_Drug specific manual Pembrolizumab 12
Protocol (for publication) D1_Drug specific manual Pemigatinib 4
Protocol (for publication) D1_Drug specific manual Regorafenib 10
Protocol (for publication) D1_Drug specific manual Rucaparib 7
Protocol (for publication) D1_Drug specific manual Selpercatinib 4
Protocol (for publication) D1_Drug specific manual Sunitinib 16
Protocol (for publication) D1_Drug specific manual Talazoparib 5
Protocol (for publication) D1_Drug specific manual Tepotinib 4
Protocol (for publication) D1_Drug specific manual Trametinib mono 13
Protocol (for publication) D1_Drug specific manual Trastuzumab_Pertuzumab 15
Protocol (for publication) D1_Drug specific manual Vemurafenib_Cobimetinib 14
Protocol (for publication) D1_Drug specific manual Vismodegib 12
Protocol (for publication) D1_Protocol 2023-509152-33_redacted 19
Protocol (for publication) D4_Questionnaire Risk Attitudes_NL 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.1
Recruitment arrangements (for publication) K2_DRUP Study website 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF adult olaparib 3rd stage QOL_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults_redacted 15.1
Subject information and informed consent form (for publication) L1_SIS Bijlage Abemaciclib 4
Subject information and informed consent form (for publication) L1_SIS Bijlage Alectinib 3
Subject information and informed consent form (for publication) L1_SIS Bijlage Alpelisib 4.1
Subject information and informed consent form (for publication) L1_SIS Bijlage Amivantamab 1
Subject information and informed consent form (for publication) L1_SIS Bijlage Atezolizumab_Bevacizumab 3
Subject information and informed consent form (for publication) L1_SIS Bijlage Axitinib 7
Subject information and informed consent form (for publication) L1_SIS Bijlage Cabozantinib 3
Subject information and informed consent form (for publication) L1_SIS Bijlage Crizotinib 8
Subject information and informed consent form (for publication) L1_SIS Bijlage Dabrafenib mono 6
Subject information and informed consent form (for publication) L1_SIS Bijlage Dabrafenib_Trametinib 6.1
Subject information and informed consent form (for publication) L1_SIS Bijlage Dacomitinib 2
Subject information and informed consent form (for publication) L1_SIS Bijlage Durvalumab 3
Subject information and informed consent form (for publication) L1_SIS Bijlage Entrectinib 3
Subject information and informed consent form (for publication) L1_SIS Bijlage Erdafitinib 4
Subject information and informed consent form (for publication) L1_SIS Bijlage Erlotinib 7
Subject information and informed consent form (for publication) L1_SIS Bijlage Ivosidenib 1
Subject information and informed consent form (for publication) L1_SIS Bijlage Lenvatinib 6
Subject information and informed consent form (for publication) L1_SIS Bijlage Lorlatinib 3
Subject information and informed consent form (for publication) L1_SIS Bijlage Nilotinib 7
Subject information and informed consent form (for publication) L1_SIS Bijlage Niraparib 5
Subject information and informed consent form (for publication) L1_SIS Bijlage Nivolumab 7
Subject information and informed consent form (for publication) L1_SIS Bijlage Nivolumab_Ipilimumab 4
Subject information and informed consent form (for publication) L1_SIS Bijlage Olaparib 11
Subject information and informed consent form (for publication) L1_SIS Bijlage Panitumumab 6
Subject information and informed consent form (for publication) L1_SIS Bijlage Pembrolizumab 7
Subject information and informed consent form (for publication) L1_SIS Bijlage Pemigatinib 3
Subject information and informed consent form (for publication) L1_SIS Bijlage Regorafenib 6
Subject information and informed consent form (for publication) L1_SIS Bijlage Rucaparib 4
Subject information and informed consent form (for publication) L1_SIS Bijlage Selpercatinib 3
Subject information and informed consent form (for publication) L1_SIS Bijlage Sunitinib 8
Subject information and informed consent form (for publication) L1_SIS Bijlage Talazoparib 3
Subject information and informed consent form (for publication) L1_SIS Bijlage Tepotinib 2
Subject information and informed consent form (for publication) L1_SIS Bijlage Trametinib mono 5.1
Subject information and informed consent form (for publication) L1_SIS Bijlage Trastuzumab_Pertuzumab 6
Subject information and informed consent form (for publication) L1_SIS Bijlage Vemurafenib_Cobimetinib 6
Subject information and informed consent form (for publication) L1_SIS Bijlage Vismodegib 7
Subject information and informed consent form (for publication) L2_Instructie verzamelen van ontlasting 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Abemaciclib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Abemaciclib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Alectinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Alectinib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Alpelisib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Alpelisib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Amivantamab 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Atezolizumab 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Atezolizumab 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Axitinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Axitinib 3
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Bevacizumab 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Bevacizumab 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Cabozantinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Cobimetinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Crizotinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Crizotinib 3
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Dabrafenib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Dabrafenib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Dacomitinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Dacomitinib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Durvalumab 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Entrectinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Entrectinib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Erdafitinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Erlotinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ipilimumab 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ipilimumab 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ivosidenib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Lenvatinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Lenvatinib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Lorlatinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Lorlatinib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Nilotinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Nilotinib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Niraparib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Nivolumab 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Nivolumab 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Olaparib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Olaparib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Panitumumab 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Panitumumab 3
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Pembrolizumab 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Pemigatinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Pertuzumab 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Pertuzumab 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Regorafenib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Rucaparib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Rucaparib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Selpercatinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Sunitinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Sunitinib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Talazoparib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Tepotinib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Trametinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Trametinib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Trastuzumab 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Vemurafenib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Vemurafenib 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Vismodegib 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_EN 11
Synopsis of the protocol (for publication) D1_Protocol synopsis_NL 11

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-03-07 Netherlands Acceptable
2024-03-26
 2024-03-26
2 SUBSTANTIAL MODIFICATION SM-1 2025-01-07 Netherlands Acceptable
2025-04-14
 2025-04-22
3 SUBSTANTIAL MODIFICATION SM-2 2025-06-17 Netherlands Acceptable
2025-08-06
 2025-08-22
4 SUBSTANTIAL MODIFICATION SM-3 2025-10-01 Netherlands Acceptable
2025-12-19
 2025-12-19

Related clinical trials