Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
16
Cancer
• To describe the anti-tumour activity of commercially available targeted anti-cancer drugs used for treatment of patients with rare and hard to treat cancers. • To describe serious toxicity related to the study treatment.
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
- 27 Mar 2025 → ongoing
- Decision date (initial)
- 2025-02-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Matrix · Industry Partners (currently Novartis)
External identifiers
- EU CT number
- 2024-513779-42-02
- ClinicalTrials.gov
- NCT06119789
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
• To describe the anti-tumour activity of commercially available targeted anti-cancer drugs used for treatment of patients with rare and hard to treat cancers.
• To describe serious toxicity related to the study treatment.
Secondary objectives 1
- To evaluate the efficiency of the investigational medication with a focus on progression-free survival, overall survival, and duration of treatment.
Conditions and MedDRA coding
Cancer
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-513779-42-01 | Precision cancer medicine in hard-to-treat rare cancers - repurposing drugs in earlier lines of treatment - MATRIX-RARE. | Oslo University Hospital HF |
| 2024-513779-42-00 | Precision cancer medicine in hard-to-treat rare cancers - repurposing drugs in earlier lines of treatment - MATRIX-RARE. | Oslo University Hospital HF |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 15
- 1. ECOG performance status 0-2
- 10. For orally administered drugs, the patient must have no known malabsorption syndrome
- 11. Results must be available from a diagnostic test performed in a preapproved laboratory. The test used to qualify a patient for participation in MATRIX-RARE 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. NGS analyses will be performed on a newly sampled biopsy if possible. Information from these analyses may be used upon progression, for evaluation of possible new cohort-inclusion
- 12. Have a genomic profile for which treatment with one of the approved targeted anti-cancer therapies included in this study has potential clinical benefit see Section 3.3.4
- Sex and Contraceptive/Barrier Requirements 13. Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use adequate highly effective methods of contraception for the duration of study participation, and for 4 to 24 months following completion of study therapy as defined in Section 11.4.
- 14. Women of child-bearing potential must have a negative highly sensitive pregnancy test no more than 72 h before treatment start, then monthly as long as contraception is required.
- 15. Male patients should avoid impregnating a female partner. Male study patients must agree to one of the following: practice effective barrier contraception as described under section 10.4 during the entire study treatment period and through a certain time after the last dose of study drug. Details are given in the “Drug specific amendment”.
- Informed Consent 16. Ability to understand and the willingness to sign a written informed consent/assent document for treatment as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- 2. Life expectancy minimum 3 months.
- 3. Age >17 years
- 4. Patients must have evaluable disease. The exception is when the treatment is after radiotherapy and/or surgery e.g. in newly diagnosed glioblastoma. RECIST v1.1 (18, 25) will be used for patients with solid tumours(26)(27). For glioblastoma patients, RANO 2.0 criteria will be used (28). iRECIST will be used for immunotherapy-cohorts (25). Patients whose disease cannot be objectively measured by physical or radiographic examination (e.g., elevated serum tumour marker only) are NOT eligible, with the exception of CA-125 for ovarian cancer and PSA for prostate cancer (29).
- 5. The patient has a rare cancer, defined as having an incidence of <6 / 100 000 / year.
- 6. The patient has an advanced cancer without effective treatment options according to ESMO-magnitude of clinical benefit scale (<4). If the ESMO-MCBS is 3, and the prognosis on standard treatment is poor (median OS <2 years), the patient can be eligible (See also chapter 5). The treatment can be administered in combination with radiation therapy, for example in patients with newly-diagnosed glioblastoma study treatment will be administered as add-on to standard treatment with radiotherapy and temozolomide. For patients with MGMT promoter methylation negative glioblastoma adjuvant temozolomide will be considered abandoned.
- 7. Ability to understand and the willingness to sign a written informed consent/assent document for molecular profiling as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- 9. Patients must have acceptable organ function as defined below: 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
Exclusion criteria 13
- 1. MOLECULAR PROFILINGPatients with the following pre-existing cardiac conditions: uncontrolled angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure.
- 10. If the patient’s tumour has a genomic variant known to confer resistance to an anti-cancer agent available in this study, the patient will not be eligible to receive that agent but will be eligible to receive other drugs available in this study if all inclusion and exclusion criteria are met for that drug.
- 11. Female patients who are pregnant or nursing
- 12. Patients who do not meet drug-specific eligibility requirements for the drug selected by the investigator.
- 13. Age < 18 years
- 2. Patients with left ventricular ejection fraction (LVEF) known to be < 40%.
- 3. 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, severe psychiatric illness situations, or anticipated or planned anti-cancer treatment or surgery.
- TREATMENT PHASE: 4. Patients eligible to enter other ongoing trials which have the potential to benefit the patients equally or more than MATRIX-RARE, and for whom access to the ongoing trials is manageable (taking geography into consideration).
- 5. 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.
- 6. Patients with known allergy/hypersensitivity to the study drug (active substance or to any of the excipients).
- 7. Patients with acute gastrointestinal bleeding within 1 month of start of treatment
- 8. Patients with stroke (including TIA) or acute myocardial infarction within 4 months before the first dose of study treatment
- 9. Previous treatment with the selected study drug for the same malignancy.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- 1) Disease control (objective complete or partial response or stable disease) at 16 weeks after treatment initiation according to established response criteria
- 2) Treatment-related grade ≥3 and serious adverse events for all cohorts.
- 3. Treatment-related grade 1-5 adverse events for cohorts with new treatment combinations
Secondary endpoints 3
- 1) Progression-free survival
- 2) Overall survival
- Duration of time on drug
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 17
SUB25387 · Substance
- Active substance
- Imatinib
- 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
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2449
- Modified vs. Marketing Authorisation
- No
SUB25387 · Substance
- Active substance
- Imatinib
- 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
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2449
- Modified vs. Marketing Authorisation
- No
Finlee 10 mg dispersible tablets
PRD10959480 · Product
- Active substance
- Dabrafenib
- Substance synonyms
- GSK2118436
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- 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/1/23/1767/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2372
- Modified vs. Marketing Authorisation
- No
Tevimbra 100 mg concentrate for solution for infusion
PRD11015698 · Product
- Active substance
- Tislelizumab
- Substance synonyms
- BGB-A317, JHL-2108
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF09 — -
- Marketing authorisation
- EU/1/23/1758/001
- MA holder
- BEONE MEDICINES IRELAND LIMITED.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tevimbra 100 mg concentrate for solution for infusion
PRD11015696 · Product
- Active substance
- Tislelizumab
- Substance synonyms
- BGB-A317, JHL-2108
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF09 — -
- Marketing authorisation
- EU/1/23/1758/001
- MA holder
- BEONE MEDICINES IRELAND LIMITED.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tevimbra 100 mg concentrate for solution for infusion
PRD11015699 · Product
- Active substance
- Tislelizumab
- Substance synonyms
- BGB-A317, JHL-2108
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF09 — -
- Marketing authorisation
- EU/1/23/1758/001
- MA holder
- BEONE MEDICINES IRELAND LIMITED.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tevimbra 100 mg concentrate for solution for infusion
PRD11015697 · Product
- Active substance
- Tislelizumab
- Substance synonyms
- BGB-A317, JHL-2108
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF09 — -
- Marketing authorisation
- EU/1/23/1758/001
- MA holder
- BEONE MEDICINES IRELAND LIMITED.
- MA country
- Iceland
- 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 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/1/13/865/003
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
- The labelling of the marketed product has been modified for use in this clinical trial.
PRD3045783 · 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/1/13/865/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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 Month(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 prioduct used. Study specific labelling has been added for use in the trial
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
- 10000 mg milligram(s)
- Max treatment duration
- 100 Month(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
- Yes
- Modification description
- Marketed product has had labelling added for use in a clinical trial
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
- 10000 mg milligram(s)
- Max treatment duration
- 100 Month(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
Spexotras 0.05 mg/ml powder for oral solution
PRD11036109 · Product
- Active substance
- Trametinib
- Substance synonyms
- GSK1120212B
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- 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/1/23/1781/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2374
- Modified vs. Marketing Authorisation
- No
Tibsovo 250 mg film-coated tablets
PRD10392230 · Product
- Active substance
- Ivosidenib
- Substance synonyms
- AG-120
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 250 mg milligram(s)
- Max total dose
- 10000 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XX62 — -
- Marketing authorisation
- EU/1/23/1728/001
- MA holder
- LES LABORATOIRES SERVIER (SURESNES)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Voranigo 40 mg film-coated tablets
PRD12903239 · Product
- Active substance
- Vorasidenib
- Substance synonyms
- 6-(6-chloropyridin-2-yl)-N2,N4-bis[(2R)-1,1,1-trifluoropropan-2-yl]-1,3,5-triazine-2,4-diamine, AG-881
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 10000 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XM04 — -
- Marketing authorisation
- EU/1/25/1912/002
- MA holder
- LES LABORATOIRES SERVIER (SURESNES)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Voranigo 10 mg film-coated tablets
PRD12903238 · Product
- Active substance
- Vorasidenib
- Substance synonyms
- 6-(6-chloropyridin-2-yl)-N2,N4-bis[(2R)-1,1,1-trifluoropropan-2-yl]-1,3,5-triazine-2,4-diamine, AG-881
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XM04 — -
- Marketing authorisation
- EU/1/25/1912/001
- MA holder
- LES LABORATOIRES SERVIER (SURESNES)
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 6
PRD2864129 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 180 mg milligram(s)
- Max total dose
- 10000 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/98/096/020
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2864128 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 250 mg milligram(s)
- Max total dose
- 10000 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/98/096/021
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2864122 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 10000 mg milligram(s)
- Max treatment duration
- 100 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/98/096/013
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2864132 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 140 mg milligram(s)
- Max total dose
- 10000 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/98/096/017
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Temodal 2.5 mg/ml powder for solution for infusion
PRD2864130 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 2.5 mg/ml milligram(s)/millilitre
- Max total dose
- 10000 mg/ml milligram(s)/millilitre
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/98/096/023
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2864123 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 10000 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/98/096/015
- MA holder
- MERCK SHARP & DOHME B.V.
- 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
- Åslaug Helland
Locations
1 EU/EEA country · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 100 | 16 |
| Rest of world | — | 0 | — |
Investigational sites
Nord-Trondelag Hospital Trust
Oncology, Kirkegata 2, 7600, Levanger
Helse Bergen HF
Oncology, Jonas Lies Vei 65, 5021, Bergen
Stavanger University Hospital HF
Department of Oncology, Helse Stavanger HF, Postboks 8100, Stavanger
Nordlandssykehuset HF
Oncology, Parkveien 95, 8005, Bodo
Helse Forde HF
Oncology, Svanehaugvegen 2, 6812, Foerde
Sykehuset Telemark HF
Oncology, Ulefossvegen 55, 3710, Skien
Sykehuset Innlandet HF
Oncology, P. O. Box 104, 2381, Brumunddal
Ostfold Hospital Trust
Oncology, P. O. Box 16, 1603, Fredrikstad
Sorlandet Sykehus HF
Oncology, Egsveien 100, 4615, Kristiansand S
Helse Fonna HF
Oncology, Karmsundgata 120, 5528, Haugesund
Helse Moere Og Romsdal HF
Oncology, Aasehaugen 5, 6017, Aalesund
Sykehuset Innlandet HF
Oncology, Furnesvegen 26, 2382, Brumunddal
St. Olavs Hospital HF
Oncology, P. O. Box 3250, Torgarden, Trondheim
Universitetssykehuset Nord-Norge HF
Oncology, Sykehusvegen 38, 9019, Tromsoe
Vestfold Hospital Trust
Oncology, Sykehuset i Vestfold HF, Postboks 2168, Tønsberg
Oslo University Hospital HF
Oncology, Taarnbygget, Kirkeveien 166, Oslo
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 | 2025-03-27 | 2025-03-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 37 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2024-513779-42-02 Drug Specific Amendment - tislelizumb Tevimbra | 1.1 |
| Protocol (for publication) | D1_ Protocol 2024-513779-42-02 DSA Trametinib Dabrafenib | 1.4 |
| Protocol (for publication) | D1_Drug Specific Amendment vorasidenib Voranigo CLEAN | 1 |
| Protocol (for publication) | D1_Investigational Medicinal Products Matrix Rare | 3 |
| Protocol (for publication) | D1_Investigational Medicinal Products Matrix Rare_TC | 3 |
| Protocol (for publication) | D1_Master Protocol_MATRIX_RARE 2024-513779-42-02 | 1.4 |
| Protocol (for publication) | D1_Protocol 2024-513779-42-02 Drug Specific Amendment - Dabrafenib | 1.4 |
| Protocol (for publication) | D1_Protocol 2024-513779-42-02 Drug Specific Amendment - Imatinib | 1.4 |
| Protocol (for publication) | D1_Protocol 2024-513779-42-02 Drug Specific Amendment - Trametinib | 1.4 |
| Protocol (for publication) | D1_Protocol 2024-513779-42-02 Drug Specific Amendment Tibsovo Ivosidenib CLEAN | 1.0 |
| Protocol (for publication) | D4_Patient facing document drug diary trametinib | 1 |
| Protocol (for publication) | D4_Patient Facing Document Effective UK EN EQ_5D_5L Paper Self_Complete v1_2 | 1.2 |
| Protocol (for publication) | D4_Patient Facing Document GAD-7_EN | 1 |
| Protocol (for publication) | D4_Patient Facing Document PHQ-9_ EN | 1 |
| Protocol (for publication) | D4_Patient Facing Document QLQ-C30 EN | 3.0 |
| Protocol (for publication) | D4_Patient Facng Document_ Fatigue Questionnaire EN | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Subject information and informed consent form (for publication) | L1 SIS ICF Samtykke screening MATRIX RARE NO_clean | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ivosidenib 10 March 2026 CLEAN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF tislelizumb_Tevimbra | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF vorasidenib 10 March 2026 CLEAN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_Samtykke_dabrafenib_trametinib_NO Clean | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_Samtykke_imatinib_NO clean | 1.3 |
| Subject information and informed consent form (for publication) | L2 pasientkort Matrix Rare | 1 |
| Subject information and informed consent form (for publication) | L2_Informasjonsskriv_kontaktopplysninger kohortpasienter | 1 |
| Subject information and informed consent form (for publication) | LI_SIS and ICF Dabrafenib v1_3 | 2 |
| Subject information and informed consent form (for publication) | LI_SIS and ICF Dabrafenib v1_3 TC | 2 |
| Subject information and informed consent form (for publication) | LI_SIS_ICF_Samtykke_trametinib clean | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Mekinist | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Spexotras | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Finlee | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Imatinib Teva | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Tafinlar | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC tibsovo | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC voranigo | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Tevimbra | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NO_2024-513779-42-02 clean | 1.2 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-17 | Norway | Acceptable 2025-02-12
|
2025-02-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-27 | Norway | Acceptable 2025-05-30
|
2025-05-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-12 | Norway | Acceptable 2025-09-12
|
2025-09-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-06 | Norway | Acceptable | 2025-10-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-26 | Norway | Acceptable 2026-05-27
|
2026-05-29 |