Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
250
Countries
1
Sites
5
Advanced Cancer
Disease control rate at 16 weeks after treatment initiation (defined as patients by CR, PR, SD)
Key facts
- Sponsor
- HUS-Yhtymae
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 6 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Faron Pharmaceuticals Ltd. · Merck Healthcare KGaA · Incyte Biosciences International S.A.R.L. · Roche Oy · Lilly Oy · Janssen-Cilag Oy · Bayer Oy · Novartis Oy
External identifiers
- EU CT number
- 2024-517478-68-01
- EudraCT number
- 2021-000689-14
- ClinicalTrials.gov
- NCT05159245
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
Disease control rate at 16 weeks after treatment initiation (defined as patients by CR, PR, SD)
Secondary objectives 5
- Duration of treatment on study (time on drug)
- Treatment-related grade ≥3 and serious adverse events
- Best overall response (defined as patients by CR, PR, SD)
- Progression free survival
- Overall survival
Conditions and MedDRA coding
Advanced Cancer
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- Safety reporting (SAE, SUSAR) with respective company supporting study drugs on continuous basis during the trial. Safety reports are submitted with respective companies electronic systems (at the same time as for national regulatory authority). As part of EU project collaboration, PRIME-ROSE, cohort data including molecular change and response data, is being shared with European DRUP trials.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-517478-68-00 | The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs to determine the Efficacy in Treatment of Advanced Cancers with a Known Molecular Profile | HUS-Yhtymae |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Adult (age ≥ 18 years) patient with a histologically-confirmed locally advanced or metastatic cancer who is no longer benefitting from curative anti-cancer treatment or for whom no such treatment is available or indicated.
- ECOG performance status 0-2
- 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 > 8.0 mmol/l c.Platelets > 75 x 109/l For hematological patients: 3.c. is not applicable for hematological cancers as abnormal blood counts are often caused by advanced disease, and they normalize with successful therapy. d.Total bilirubin < 1.5 x ULN e.AST and ALT < 3 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 ≥ 40 mL/min/1.73 m2
- Patients must have objectively evaluable or measurable disease (by physical, radiographic or laboratory examination, according to RECIST v1.1, Lugano, IWG and ELN-AML, IMWG, RANO, GCIG, iRESIST or PCWG3.
- Results must be available from a tumor molecular profiling. 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) or immunohistochemistry (IHC). The test may have been performed on the primary tumor or a metastatic lesion, in a diagnostic laboratory or within the context of another commercial platform (eg Foundation Medicine), 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
- Patients must have a tumor profile for which treatment with one of the approved (or under revision for approval or for which otherwise sufficient safety data has been established) targeted anti-cancer drugs included in this study has potential clinical benefit based on preclinical data or clinical information (see section 5).
- A new (obtained ≤6 months before inclusion after which no further anti-cancer therapy is allowed) fresh frozen and FFPE tumor biopsy specimen or liquid biopsy for extensive biomarker testing is mandatory before the start of treatment with a targeted agent included in the protocol. a. An exception is made for patients, if the pre-treatment biopsy for biomarker analysis cannot safely be obtained: i) The fresh frozen tumor biopsy sample may be replaced by fresh frozen tumor tissue, obtained earlier, as part of standard of care surgical procedure (i.e., performed at progression) ii) If no fresh frozen tumor tissue is available for NGS, and the risk of obtaining a new tumor biopsy is considered too high, no biopsy will be required. A liquid biopsy is recommended in these cases.
- Ability to understand and the willingness to sign a written or electronic informed consent document and comply to the protocol.
- For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
- Because of the risks of drug treatment to the developing fetus, 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 9
- Ongoing toxicity > grade 2, other than alopecia or > grade 1 neuropathy.
- 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: a. Patients suffering from CRPC are allowed to continue androgen deprivation therapy. b. Medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates). These medications must have been started ≥ 1 week prior to enrollment on this study.
- Patient is pregnant or nursing
- Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient is clinically stable and off steroids for at least 4 weeks prior to study initiation.
- Additional exclusion criteria specific for GBM patients: 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 unless for palliative intent to treat pain symptoms. c. No radiotherapy with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven.
- Patients with clinically significant preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.
- Patients with known left ventricular ejection fraction (LVEF) < 45% are not eligible
- Patients with stroke (including TIA) or acute myocardial infarction within 3 months before the first dose of study treatment are not eligible
- 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 1
- Disease control rate at 16 weeks after treatment initiation (defined as patients by CR, PR, SD)
Secondary endpoints 5
- Duration of treatment on study (time on drug)
- Treatment-related grade ≥3 and serious adverse events
- Best overall response (defined as patients by CR, PR, SD)
- Progression free survival
- Overall survival
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 21
Scemblix 40 mg film-coated tablets
PRD10139000 · Product
- Active substance
- Asciminib Hydrochloride
- Substance synonyms
- ABL001-AAA, N-(4-(chlorodifluoromethoxy)phenyl)-6-((3R)-3-hydroxypyrrolidin-1-yl)-5-(1H-pyrazol-3-yl)pyridine-3-carboxamide monohydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA06 — -
- Marketing authorisation
- EU/1/22/1670/005
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Abraxane 5 mg/ml powder for dispersion for infusion.
PRD9254303 · Product
- Active substance
- Paclitaxel Albumin-Bound
- Substance synonyms
- PACLITAXEL ALBUMINE-BOUND
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 260 mg/m2 milligram(s)/square meter
- Max total dose
- 260 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- EU/1/07/428/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Iclusig 15 mg film-coated tablets
PRD12199383 · Product
- Active substance
- Ponatinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 45 mg milligram(s)
- Max total dose
- 45 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA05 — -
- Marketing authorisation
- EU/1/13/839/001
- MA holder
- INCYTE BIOSCIENCES UK LTD
- MA country
- United Kingdom
- 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
- INJECTION
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 150 Week(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
PRD3045785 · 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
- 300 mg milligram(s)
- Max treatment duration
- 150 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EC02 — -
- Marketing authorisation
- EU/1/13/865/003
- MA holder
- NOVARTIS EUROPHARM LIMITED
- 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
- INJECTION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 150 Week(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
Erleada 60 mg film-coated tablets
PRD6957697 · Product
- Active substance
- Apalutamide
- Substance synonyms
- ARN-509
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 150 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02BB05 — -
- Marketing authorisation
- EU/1/18/1342/003
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4815708 · Product
- Active substance
- Alectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 150 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01ED03 — -
- Marketing authorisation
- EU/1/16/1169/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
- 800 mg milligram(s)
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 150 Week(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
Cotellic 20 mg film-coated tablets
PRD3439656 · Product
- Active substance
- Cobimetinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 150 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EE02 — -
- Marketing authorisation
- EU/1/15/1048/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11185940 · 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
- 13.5 mg milligram(s)
- Max treatment duration
- 150 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EN02 — -
- Marketing authorisation
- EU/1/21/1535/001
- MA holder
- INCYTE BIOSCIENCES DISTRIBUTION B.V.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Mekinist 0.5 mg film-coated tablets
PRD3045762 · 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
- 2 mg milligram(s)
- Max treatment duration
- 150 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EE01 — -
- Marketing authorisation
- EU/1/14/931/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Rozlytrek 200 mg hard capsules
PRD8236731 · 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
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 150 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EX14 — -
- Marketing authorisation
- EU/1/20/1460/002
- 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
PRD7537922 · Product
- Active substance
- Atezolizumab
- Substance synonyms
- RO5541267
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 840 mg milligram(s)
- Max total dose
- 840 mg milligram(s)
- Max treatment duration
- 150 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF05 — -
- Marketing authorisation
- EU/1/17/1220/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2153970 · Product
- Active substance
- Vismodegib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 150 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
Stivarga 40 mg film-coated tablets
PRD1714052 · Product
- Active substance
- Regorafenib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 160 mg milligram(s)
- Max treatment duration
- 150 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XE21 — -
- Marketing authorisation
- EU/1/13/858/001
- MA holder
- BAYER AG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
- 450 mg milligram(s)
- Max treatment duration
- 150 Week(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
- No
Zelboraf 240 mg film-coated tablets
PRD2154737 · Product
- Active substance
- Vemurafenib
- Substance synonyms
- RO5185426, PLX4032, N-(3-((5-(4-CHLOROPHENYL)-1H-PYRROLO(2,3-B)PYRIDIN-3-YL)CARBONYL)-2,4- DIFLUOROPHENYL)PROPANE-1-SULFONAMIDE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1920 mg milligram(s)
- Max total dose
- 1920 mg milligram(s)
- Max treatment duration
- 150 Week(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
Verzenios 50 mg film-coated tablets
PRD6701098 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 150 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Mekinist 2 mg film-coated tablets
PRD3045799 · 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
- 2 mg milligram(s)
- Max treatment duration
- 150 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EE01 — -
- Marketing authorisation
- EU/1/14/931/005
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6575771 · Product
- Active substance
- Bexmarilimab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 3 mg/kg milligram(s)/kilogram
- Max total dose
- 3 mg/kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- FARON PHARMACEUTICALS LTD
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Co-ordinating Principal Investigator
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Research Coordinator
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 250 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Oulu University Hospital
Cancer Center, Kajaanintie 50, 90220, Oulu
Pirkanmaan hyvinvointialue
Cancer Centre, P. O. Box 272, 33101, Tampere
Varsinais-Suomen hyvinvointialue
Cancer Centre, Kiinamyllynkatu 4-8, 20520, Turku
Pohjois-Savon hyvinvointialue
Center of Oncology, Puijonlaaksontie 2, P. O. Box 1711, Kuopio
HUS-Yhtymae
Comprehensive Cancer Center, Clinical Trial Unit, Haartmaninkatu 4, 00290, Helsinki
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 |
|---|---|---|---|---|---|
| Finland | 2024-11-06 | 2024-11-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 36 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | FINPROVE_protocol_2024-517478-01 | 8.2 |
| Protocol (for publication) | FINPROVE_protocol_v7 | 1 |
| Recruitment arrangements (for publication) | informedconsent_patientrecruitmentprocedure_fi_FINPROVE | 1 |
| Subject information and informed consent form (for publication) | Appendix_FINPROVE_ICF | 5 |
| Subject information and informed consent form (for publication) | Bilaga_FINPROVE_samtyckesblankett | 5 |
| Subject information and informed consent form (for publication) | Forscreening Information och samtyckesblankett_FINPROVE | 5 |
| Subject information and informed consent form (for publication) | Information och samtyckesblankett_FINPROVE | 6 |
| Subject information and informed consent form (for publication) | Liite tutkimustiedotteeseen_FINPROVE | 1 |
| Subject information and informed consent form (for publication) | Screening SIS and ICF_FINPROVE | 5 |
| Subject information and informed consent form (for publication) | Seulonta tiedote ja suostumus_FINPROVE | 5 |
| Subject information and informed consent form (for publication) | SIS_and_ICF_FINPROVE | 6 |
| Subject information and informed consent form (for publication) | Tiedote ja suostumus_FINPROVE | 6 |
| Subject information and informed consent form (for publication) | Tutkittavalle annettava muu materiaali EQ-5D-5L_EN | 1 |
| Subject information and informed consent form (for publication) | Tutkittavalle annettava muu materiaali EQ-5D-5L_FI | 1 |
| Subject information and informed consent form (for publication) | Tutkittavalle annettava muu materiaali EQ-5D-5L_SV | 1 |
| Subject information and informed consent form (for publication) | Tutkittavalle annettava muu materiaali QLQ-C30 English | 1 |
| Subject information and informed consent form (for publication) | Tutkittavalle annettava muu materiaali QLQ-C30 Finnish | 1 |
| Subject information and informed consent form (for publication) | Tutkittavalle annettava muu materiaali QLQ-C30 Swedish | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Bexmarilimab SmPC not available | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Abraxane | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Alecensa | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Cotellic | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Erleada | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Iclusig | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Lynparza | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Mekinist | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Pemazyre | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Phesgo | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Rozlytrek | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Scemblix | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Stivarga | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Tafinlar | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Tecentriq | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Tepmetko | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Verzenios | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Zelboraf | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-11 | Finland | Acceptable 2024-11-06
|
2024-11-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-17 | Finland | Acceptable with conditions 2026-03-02
|
2026-03-11 |