Improving public cancer care by implementing precision medicine in Norway

Start 1 Apr 2021 · Status Ongoing, recruiting · 1 EU/EEA countries · 23 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Ongoing, recruiting

Participants planned 1,000

Countries 1

Sites 23

Cancer

Key facts

Sponsor: Oslo University Hospital HF
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 1 Apr 2021 → ongoing
Decision date (initial): 2024-08-23
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: Radiumhospitalets legater · Pharmaceutical companies · Norwegian Cancer Society · Klinbeforsk

External identifiers

EU CT number: 2023-507894-16-00
EudraCT number: 2020-004414-35
ClinicalTrials.gov: NCT04817956

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To describe the anti-tumour activity and toxicity of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced malignancy that harbours a genomic- or protein expression variant known to be a drug target or to predict sensitivity to a drug.

To facilitate patient access to commercially available, targeted anti-cancer drugs of potential efficacy for treatment of an advanced malignancy that harbours a genomic or protein expression variant known to be a drug target or to predict sensitivity to a drug.

Secondary objectives 1

To further describe tumour response to treatment

Conditions and MedDRA coding

Cancer

Study design 2 periods

#	Title	Allocation	Blinding	Roles blinded	Arms
1	Molecular profiling The molecular profiling will consist of at least TSO500 or similar tests, and potentially additional tests depending on indication and available drugs.	Not Applicable	None
2	Treatment Patients will be enrolled in multiple parallel cohorts, each defined by 1 tumour type, 1 tumour profile and 1 study drug. Patients will be treated with commercially available targeted anti-cancer drugs.	Not Applicable	None

Regulatory references

Scientific advice from competent authorities: Norwegian Medical Products Agency
Plan to share IPD: Yes
IPD plan description: Patients from the Netherlands, Denmark, Sweden, and most likely several other European countries will be included in similar but independent protocols. Data from these protocols can be exchanged to ensure sufficient patient numbers for analyses of efficacy in every cohort, see protocol section 9.3 for more information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

ECOG performance status 0-2
Life expectancy minimum 3 months
Patient with a pathology-proven locally advanced or metastatic malignant disease who is no longer benefitting from standard anti-cancer treatment or for whom, in the opinion of the investigator, no such treatment is available or indicated.
Patients must have acceptable organ function as defined below (exceptions for haematological diagnoses): a) Absolute neutrophil count ≥ 1.5 x109 / L b) Hemoglobin > 9 g/dl c) Platelets > 75,000/µl d) Total bilirubin < 1.5 x institutional upper limit of normal (ULN) e) AST (SGOT) and ALT(SGPT) < 2.5 x institutional upper limit of normal (ULN) (or < 5 x ULN in patients with known hepatic metastases) f) Calculated or measured creatinine clearance ≥ 40 mL/min/1.73 m2
For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
Results must be available from a genomic / molecular test performed in a preapproved laboratory (Section 10.1). The test used to qualify a patient for participation in IMPRESS-Norway may have been performed on any specimen of the patient’s tumour obtained at any point during the patient’s care at the discretion of the patient’s treating physician. Genomic assays performed on cell-free DNA in plasma (“liquid biopsies”) will also be acceptable if the genomic analysis is performed as defined in Section 10.5. NGS analyses will be performed on a newly sampled biopsy if possible. Information from these analyses might be used upon progression, for evaluation of possible new cohort-inclusion.
Have a genomic profile for which treatment with one of the approved targeted anti-cancer therapies included in this study has potential clinical benefit

Exclusion criteria 4

Patients eligible to enter other ongoing trials which have the potential to benefit the patients equally or more than a IMPRESS-Norway cohort, and for
Ongoing toxicity > CTCAE grade 2, other than peripheral neuropathy, related to anti-tumour treatment that was completed within 4 weeks prior to treatment initiation. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3.Patients with known allergy/hypersensitivity to the study drug (active substance or to any of the excipients).
Patients with acute gastrointestinal bleeding within 1 month of start of treatment
Patients with stroke (including TIA) or acute myocardial infarction within 4 months before the first dose of study treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

Number of patients that are included and treated based on their molecular tumour profile; (from protocol V10.0 onwards)
Percentage of patients that are included and treated based on their molecular tumour profile; (protocol till version 10.0
Treatment-related grade ≥3 and serious adverse events
Disease control (objective complete or partial response or stable disease) at 16 weeks after treatment initiation according to established response criteria;

Secondary endpoints 3

Progression-free and overall survival
Duration of time on drug
Time from the molecular diagnostics first informed consent to starting treatment (Protocol version V1-9)

Investigational products

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

Test 41

TEPMETKO 225 mg film-coated tablets

PRD9570282 · 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: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01EX21 — -
Marketing authorisation: EU/1/21/1596/001
MA holder: MERCK EUROPE B.V.
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The commercially available product has been repacked

Piqray 150 mg film-coated tablets

PRD8234895 · 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 USE
Max daily dose: 300 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01EM03 — -
Marketing authorisation: EU/1/20/1455/002
MA holder: NOVARTIS EUROPHARM LIMITED
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Marketed product has been added labelling for clinical trial

Piqray 200 mg film-coated tablets

PRD8234907 · 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 USE
Max daily dose: 300 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01EM03 — -
Marketing authorisation: EU/1/20/1455/008
MA holder: NOVARTIS EUROPHARM LIMITED
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Marketed product has been added labelling for clinical trial

Piqray 50 mg and 200 mg film-coated tablets

PRD8235739 · 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 USE
Max daily dose: 300 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01EM03 — -
Marketing authorisation: EU/1/20/1455/005
MA holder: NOVARTIS EUROPHARM LIMITED
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Marketed product has been added labelling for clinical trial

Imatinib

SUB25387 · Substance

Active substance: Imatinib
Pharmaceutical form: FILM COATED TABLET
Route of administration: ORAL USE
Max daily dose: 400 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Imatinib

SUB25387 · Substance

Active substance: Imatinib
Pharmaceutical form: FILM COATED TABLET
Route of administration: ORAL USE
Max daily dose: 400 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Niraparib

SUB177208 · Substance

Active substance: Niraparib
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 300 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: This is not the marketed drug

Fulvestrant SUN 250 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte

PRD7874426 · Product

Active substance: Fulvestrant
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAMUSCULAR
Max daily dose: 500 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L02BA03 — FULVESTRANT
Marketing authorisation: 19-13037
MA holder: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
MA country: Norway
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: 0000000
Modified vs. Marketing Authorisation: No

Alecensa 150 mg hard capsules

PRD4815707 · Product

Active substance: Alectinib Hydrochloride
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 1200 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01ED03 — -
Marketing authorisation: EU/1/16/1169/001
MA holder: ROCHE REGISTRATION GMBH
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: 000000
Modified vs. Marketing Authorisation: No

Dostarlimab

SUB195307 · Substance

Active substance: Dostarlimab
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 500 mg milligram(s)
Max total dose: 16000 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: 000000
Modified vs. Marketing Authorisation: Yes
Modification description: This is not the marketed drug

Ceritinib

SUB130802 · Substance

Active substance: Ceritinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 450 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Marketed product has been added labelling for clinical trial.

Tabrecta 150 mg film-coated tablets

PRD9779740 · Product

Active substance: Capmatinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 800 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01EX17 — -
Marketing authorisation: EU/1/22/1650/002
MA holder: NOVARTIS EUROPHARM LIMITED
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Marketed product has been added labelling for clinical trial.

Tabrecta 200 mg film-coated tablets

PRD9779748 · Product

Active substance: Capmatinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 800 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01EX17 — -
Marketing authorisation: EU/1/22/1650/004
MA holder: NOVARTIS EUROPHARM LIMITED
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Marketed product has been added labelling for clinical trial.

Erivedge 150 mg hard capsules

PRD2153970 · Product

Active substance: Vismodegib
Substance synonyms: GDC-0449, RO5450815
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 150 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Week(s)
Authorisation status: Authorised
ATC code: L01XJ01 — -
Marketing authorisation: EU/1/13/848/001
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rozlytrek 100 mg hard capsules

PRD8236780 · Product

Active substance: Entrectinib
Substance synonyms: NMS-1191372, N-[5-(3,5-DIFLUOROBENZYL)-1H-INDAZOL-3-YL]-4-(4 METHYLPIPERAZIN-1-YL)-2-(TETRAHYDRO-2H-PYRAN-4-YLAMINO)BENZAMIDE
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 600 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01EX14 — -
Marketing authorisation: EU/1/20/1460/001
MA holder: ROCHE REGISTRATION GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: 000000
Modified vs. Marketing Authorisation: No

Rozlytrek 200 mg hard capsules

PRD8236755 · Product

Active substance: Entrectinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 600 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 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

Zelboraf 240 mg film-coated tablets

PRD2154737 · Product

Active substance: Vemurafenib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 1920 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01EC01 — -
Marketing authorisation: EU/1/12/751/001
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
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 USE
Max daily dose: 1680 mg milligram(s)
Max total dose: 43680 mg milligram(s)
Max treatment duration: 24 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: Yes
Orphan designation number: 000000
Modified vs. Marketing Authorisation: No

Tecentriq 1 875 mg solution for injection

PRD11048644 · Product

Active substance: Atezolizumab
Substance synonyms: RO5541267
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS USE
Max daily dose: 1875 mg milligram(s)
Max total dose: 43680 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01FF05 — -
Marketing authorisation: EU/1/17/1220/003
MA holder: ROCHE REGISTRATION GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Tecentriq 840 mg concentrate for solution for infusion

PRD7537923 · Product

Active substance: Atezolizumab
Substance synonyms: RO5541267
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 1680 mg milligram(s)
Max total dose: 43680 mg milligram(s)
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01FF05 — -
Marketing authorisation: EU/1/17/1220/002
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Phesgo 1200 mg/600 mg solution for injection

PRD8600161 · Product

Active substance: Trastuzumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS USE
Max daily dose: 1200 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01XY02 — -
Marketing authorisation: EU/1/20/1497/001
MA holder: ROCHE REGISTRATION GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Phesgo 600 mg/600 mg solution for injection

PRD8601830 · Product

Active substance: Trastuzumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS USE
Max daily dose: 1200 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01XY02 — -
Marketing authorisation: EU/1/20/1497/002
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Tafinlar 50 mg hard capsules

PRD3045784 · Product

Active substance: Dabrafenib
Substance synonyms: GSK2118436
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 300 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Week(s)
Authorisation status: Authorised
ATC code: L01EC02 — -
Marketing authorisation: EU/1/13/865/002
MA holder: NOVARTIS EUROPHARM LIMITED
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Marketed product has been added labelling for clinical trial.

Tafinlar 75 mg hard capsules

PRD3045797 · Product

Active substance: Dabrafenib
Substance synonyms: GSK2118436
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 300 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01EC02 — -
Marketing authorisation: EU/1/13/865/004
MA holder: NOVARTIS EUROPHARM LIMITED
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Marketed product has been added labelling for clinical trial.

Bortezomib

SUB20020 · Substance

Active substance: Bortezomib
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS USE
Max daily dose: 1.3 mg/m2 milligram(s)/sq. meter
Max total dose: 10000 mg/m2 milligram(s)/sq. meter
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Amivantamab

SUB193051 · Substance

Active substance: Amivantamab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 2240 mg milligram(s)
Max total dose: 500000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Packaging

Amivantamab

SUB193051 · Substance

Active substance: Amivantamab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS ADMINISTRATION
Max daily dose: 1400 mg milligram(s)
Max total dose: 100000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: packaging

Pemazyre 4.5 mg tablets

PRD8840284 · Product

Active substance: Pemigatinib
Substance synonyms: INCB054828, FGFR INHIBITOR INCB054828
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 13.5 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01EN02 — -
Marketing authorisation: EU/1/21/1535/001
MA holder: INCYTE BIOSCIENCES DISTRIBUTION B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: 000000
Modified vs. Marketing Authorisation: Yes
Modification description: The IMP is slightly different from commercially available product with different packaging

Lynparza 150 mg film-coated tablets

PRD6152224 · 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: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01XX46 — -
Marketing authorisation: EU/1/14/959/004
MA holder: ASTRAZENECA AB
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Lynparza 100 mg film-coated tablets

PRD6163467 · 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: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01XX46 — -
Marketing authorisation: EU/1/14/959/002
MA holder: ASTRAZENECA AB
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mekinist 2 mg film-coated tablets

PRD3853382 · Product

Active substance: Trametinib
Substance synonyms: GSK1120212B
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 2 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01EE01 — -
Marketing authorisation: EU/1/14/931/006
MA holder: NOVARTIS EUROPHARM LIMITED
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Marketed product has been added labelling for clinical trial.

Mekinist 0.5 mg film-coated tablets

PRD3045763 · Product

Active substance: Trametinib
Substance synonyms: GSK1120212B
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 2 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Week(s)
Authorisation status: Authorised
ATC code: L01EE01 — -
Marketing authorisation: EU/1/14/931/002
MA holder: NOVARTIS EUROPHARM LIMITED
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Marketed product has been added labelling for clinical trial.

Dexamethasone

SUB07017MIG · Substance

Active substance: Dexamethasone
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hydroxycarbamide

SUB08076MIG · Substance

Active substance: Hydroxycarbamide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 500 mg milligram(s)
Max total dose: 84000 mg milligram(s)
Max treatment duration: 6 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Retsevmo 80 mg hard capsules

PRD9027391 · 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 USE
Max daily dose: 320 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01EX22 — -
Marketing authorisation: EU/1/20/1527/011
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Retsevmo 40 mg hard capsules

PRD9027387 · 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 USE
Max daily dose: 320 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Week(s)
Authorisation status: Authorised
ATC code: L01EX22 — -
Marketing authorisation: EU/1/20/1527/006
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: 000000
Modified vs. Marketing Authorisation: No

Melphalan

SUB08728MIG · Substance

Active substance: Melphalan
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 2 mg milligram(s)
Max total dose: 112 mg milligram(s)
Max treatment duration: 8 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Avastin 25 mg/ml concentrate for solution for infusion.

PRD2153901 · Product

Active substance: Bevacizumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 7.5 mg/kg milligram(s)/kilogram
Max total dose: 10000 mg/Kg milligram(s)/kilogram
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01FG01 — -
Marketing authorisation: EU/1/04/300/001
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Avastin 25 mg/ml concentrate for solution for infusion.

PRD2153902 · Product

Active substance: Bevacizumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 7.5 mg/kg milligram(s)/kilogram
Max total dose: 10000 mg/Kg milligram(s)/kilogram
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01FG01 — -
Marketing authorisation: EU/1/04/300/002
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dactinomycin

SUB13528MIG · Substance

Active substance: Dactinomycin
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 15 µg/Kg microgram(s)/kilogram
Max total dose: 450 µg/Kg microgram(s)/kilogram
Max treatment duration: 30 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cotellic 20 mg film-coated tablets

PRD3442383 · Product

Active substance: Cobimetinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 600 mg milligram(s)
Max total dose: 10000 mg milligram(s)
Max treatment duration: 100 Month(s)
Authorisation status: Authorised
ATC code: L01EE02 — -
Marketing authorisation: EU/1/15/1048/001
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

Sponsor organisation: Oslo University Hospital HF
Address: Taarnbygget, Kirkeveien 166 Kirkeveien 166
City: Oslo
Postcode: 0450
Country: Norway

Scientific contact point

Organisation: Oslo University Hospital HF
Contact name: Åslaug Helland

Public contact point

Organisation: Oslo University Hospital HF
Contact name: Kajsa Anna Margareta Johansson

Third parties 3

Organisation	City, country	Duties
Clinigen Clinical Supplies Management ORG-100034422	Mont-Saint-Guibert, Belgium	Code 14
Almac Clinical Services Limited ORG-100017464	Craigavon, United Kingdom (Northern Ireland)	Code 14
Catalent Germany Schorndorf GmbH ORG-100011845	Schorndorf, Germany	Code 14

Locations

1 EU/EEA country · 23 investigational sites

By country

Country	MS status	Planned subjects	Sites
Norway	Ongoing, recruiting	1,000	23
Rest of world	—	0	—

Investigational sites

Norway

23 sites · Ongoing, recruiting

Nordlandssykehuset HF

Oncology, Parkveien 95, 8005, Bodo

Akershus University Hospital

Oncology, Sykehusveien 27, 1478, Lorenskog

Helse Forde HF

Oncology, Svanehaugvegen 2, 6812, Foerde

Sorlandet Sykehus HF

Oncology, Egsveien 100, 4615, Kristiansand S

Ostfold Hospital Trust

Oncology, P. O. Box 16, 1603, Fredrikstad

Vestfold Hospital Trust

Oncology, P. O. Box 2168, 3103, Tonsberg

Helse Fonna HF

Oncology, Karmsundgata 120, 5528, Haugesund

Lovisenberg Diakonale Sykehus AS

Oncology, Lovisenberggata 17, 0456, Oslo

Sykehuset Telemark HF

Oncology, Ulefossvegen 55, 3710, Skien

Sykehuset Innlandet HF

Oncology, Furnesvegen 26, 2382, Brumunddal

Oslo University Hospital HF

Hematology, Taarnbygget, Kirkeveien 166, Oslo

Vestre Viken HF

Oncology, Baerum, Groenland 32, 3045, Drammen

Helse Bergen HF

Oncology, Jonas Lies Vei 65, 5021, Bergen

Nord-Trondelag Hospital Trust

Oncology, Kirkegata 2, 7600, Levanger

Vestre Viken HF

Oncology, Ringerike, Groenland 32, 3045, Drammen

Oslo University Hospital HF

Oslo Myeloma Center, Taarnbygget, Kirkeveien 166, Oslo

Sykehuset Innlandet HF

Oncology, Furnesvegen 26, 2382, Brumunddal

Helse Moere Og Romsdal HF

Oncology, Aasehaugen 1, 6017, Aalesund

Helse Stavanger HF

Oncology, P. O. Box 8100, 4068, Stavanger

Universitetssykehuset Nord-Norge HF

Oncology, P. O. Box 100, 9038, Tromsoe

St. Olavs Hospital HF

Oncology, Prinsesse Kristinas G. 3, 7030, Trondheim

Oslo University Hospital HF

Oncology, Taarnbygget, Kirkeveien 166, Oslo

Vestre Viken HF

Oncology, Drammen, Groenland 32, 3045, Drammen

Country notifications

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

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Norway	2021-04-01		2021-04-14

Oversight and notifications

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

Urgent safety measures 2 · Art. 54 CTR

Urgent safety measure US-96506

Event date: 2025-09-04
Submission date: 2025-09-04
In response to: OTHER
Member states affected: Norway
Event description: Intestinal obstruction has been accessed as having areasonable relation to dostarlimab. It has been shown in colorectal cancer patient, but it cannot be ruled out for other types of cancer.
Measures taken: The informed consent document has been updated with the adverse event and will be sent out to the sites today. All patients taking dostarlimab will be asked to resign the consent. The revised informed consent document will be submitted with the next substantial modification.

Urgent safety measure US-78486

Event date: 2025-02-11
Submission date: 2025-04-09
In response to: OTHER
Member states affected: Norway
Event description: Dexamethasone dose for premedication cyclus 1 day 1 described in the DSA was too low.
Measures taken: The premedication for dexamethasone described in DSA for amivantamab was according to specifications required by Johnson and Johnson for clinical trials, but was not according the SmPC. We decided to used the recommendations in the SmPC after discussions with J&J. The rational was to minimize the risk for infusion reactions. All patients treated in the study have been premedicated with dexamethasone according to SmPC, se changes in uploaded document. The changes will be submitted as a substantial modification in April/early May.

Results and documents

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

Documents 80 files

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

Type	Title	Version
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol actinomycin and hydroxyurea	1.4
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Alecensa (no more inclusion)	1.5
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol amivantamab iv	1.2
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol amivantamab sc	1.1
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol bortezomib d-i	1.6
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol ceritinib d-i	1.5
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol dostarlimab d-i	1.3
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Erivedge (no more inclusion)	1.3
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol imatinib d-i	1.3
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Lynparza d-i	2.3
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Mekinist (no more inclusion)	1.5
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Melphalan d-i	1.4
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol niraparib d-i	1.4
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol pemigatinib d-i	1.4
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Phesgo (no more inclusion)	1.2
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Piqray (no more inclusion)	1.2
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Piqray and fulvestrant d-i (not used)	1.2
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Retsevmo d-i (not available))	1.5
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Rozlytrek (no more inclusion)	1.3
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Tabrecta d-i (not in use)	1.3
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Tafinlar (no more inclusion)	1.2
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Tafinlar and Mekinist (no inclusion)	1.5
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Tecentriq (no more inclusion)	1.6
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Tecentriq and Avastin (no inclusion)	1.6
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Tepmetko d-i	1.2
Protocol (for publication)	D1_Master protocol 2023-507894-16-00 IMPRESS and sub-protocol Zelboraf and Cotellic (no inclusion)	1.6
Protocol (for publication)	D1_Protocol 2023-507894-16-00 d-is	10.0
Protocol (for publication)	D4_Patient facing documents drug diary Mekinist (no more inclusion)	1.2
Protocol (for publication)	D4_Patient facing documents EQ-5D-5L	1.2
Protocol (for publication)	D4_Patient facing documents Fatigue_Questionnaire d-i	NA
Protocol (for publication)	D4_Patient facing documents GAD-7 d-i	NA
Protocol (for publication)	D4_Patient facing documents PHQ-9 d-i	NA
Protocol (for publication)	D4_Patient facing documents QLQ-C30 d-i	3
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1
Subject information and informed consent form (for publication)	L1_SIS and ICF actinomycin	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF actinomycinD screening	5.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Alecensa	3.3
Subject information and informed consent form (for publication)	L1_SIS and ICF amivantamab iv	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF amivantamab SC	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF bortezomib	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF bortezomib screening	5.2
Subject information and informed consent form (for publication)	L1_SIS and ICF ceritinib	1.4
Subject information and informed consent form (for publication)	L1_SIS and ICF ceritinib screening	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF dostarlimab	1.5
Subject information and informed consent form (for publication)	L1_SIS and ICF Erivedge	2.2
Subject information and informed consent form (for publication)	L1_SIS and ICF imatinib	1.3
Subject information and informed consent form (for publication)	L1_SIS and ICF Lynparza	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF master screening	4.3
Subject information and informed consent form (for publication)	L1_SIS and ICF Mekinist	1.6
Subject information and informed consent form (for publication)	L1_SIS and ICF melfalan	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF melfalan screening	5.1
Subject information and informed consent form (for publication)	L1_SIS and ICF niraparib	1.5
Subject information and informed consent form (for publication)	L1_SIS and ICF pemigatinib	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Phesgo	2.3
Subject information and informed consent form (for publication)	L1_SIS and ICF Piqray	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Piqray and fulvestrant	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Rozlytrek	2.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Tabrecta	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Tafinlar	1.4
Subject information and informed consent form (for publication)	L1_SIS and ICF Tafinlar and Mekinist	1.5
Subject information and informed consent form (for publication)	L1_SIS and ICF Tecentriq	3.4
Subject information and informed consent form (for publication)	L1_SIS and ICF Tecentriq and Avastin	3.4
Subject information and informed consent form (for publication)	L1_SIS and ICF Tepmetko	1.3
Subject information and informed consent form (for publication)	L1_SIS and ICF Zelboraf and Cotellic	3.4
Summary of Product Characteristics (SmPC) (for publication)	E1_IB atezolizumab TC	21
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Alkeran	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Bortezomib Accord	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Dexametason Abcur	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Fulvestrant	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Hydroxyurea	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Imatinib Teva	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Jemperli	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Lynparza	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Mekinist	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Piqray	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Retsevmo	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Tafinlar	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Zejula	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Zykadia	NA
Synopsis of the protocol (for publication)	D1_Protocol synopsis_NO 2023-507894-16-00	8.7

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-07-03	Norway	Acceptable 2024-08-23	2024-08-23
2	SUBSTANTIAL MODIFICATION	SM-1	2024-09-27	Norway	Acceptable 2024-12-12	2024-12-17
3	SUBSTANTIAL MODIFICATION	SM-2	2025-02-27	Norway	Acceptable	2025-03-07
4	SUBSTANTIAL MODIFICATION	SM-3	2025-06-16	Norway	Acceptable 2025-08-11	2025-08-12
5	SUBSTANTIAL MODIFICATION	SM-4	2025-09-26	Norway	Acceptable	2025-10-01
6	SUBSTANTIAL MODIFICATION	SM-5	2025-12-05	Norway	Acceptable with conditions 2026-01-21	2026-01-22
7	SUBSTANTIAL MODIFICATION	SM-6	2026-01-29	Norway	Acceptable 2026-03-20	2026-03-23
8	SUBSTANTIAL MODIFICATION	SM-8	2026-03-25	Norway	Acceptable 2026-05-12	2026-05-26

Improving public cancer care by implementing precision medicine in Norway

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 1

Conditions and MedDRA coding

Study design 2 periods

Regulatory references

Eligibility criteria

Inclusion criteria 7

Exclusion criteria 4

Endpoints

Primary endpoints 4

Secondary endpoints 3

Investigational products

Test 41

Sponsors and contacts

Oslo University Hospital HF

Scientific contact point

Public contact point

Third parties 3

Locations

By country

Investigational sites

Country notifications

Oversight and notifications

Urgent safety measures 2 · Art. 54 CTR

Results and documents

Documents 80 files

Application history

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