Rare Malignant NeoplasmPhase 2MATRIX-RareNCT06119789
Precision Cancer Therapy in Rare Cancers
A Phase 2 study testing Imatinib, Trametinib and Dabrafenib in people with Rare Malignant Neoplasm, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Some rare cancers are hard-to-treat and patients have a poor prognosis. It is known that some of these patients have targetable molecular alterations, and some benefit from targeted drugs. However in many cases these drugs are not approved for the rare cancers. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Rare Malignant Neoplasm
- What is being tested?
- Imatinib, Trametinib and Dabrafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteNorway
- Study dates
- 20 Mar 2025to 1 Aug 2036
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ECOG 0-2,
- identified biomarker,
- reasonable biochemistry
Who cannot join
- ECOG 3-5
- serious other diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kathinka Slørdahl, MD PhD contact
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0310
Åsa Öjlert, MD PhD, aasojl@ous-hf.no
Katarina Puco, MD, katpuc@ous-hf.no
About this study
Official title: The MATRIX Clinical Studies of Precision Cancer Therapy for Rare Cancers
Some rare cancers are hard-to-treat and patients have a poor prognosis. It is known that some of these patients have targetable molecular alterations, and some benefit from targeted drugs. However in many cases these drugs are not approved for the rare cancers.
In this study the aim is to do advanced molecular diagnostics to identify possible targets for therapy, and to treat accordingly.
Read the detailed description
All patients will have the tumour cells diagnosed with a large genepanel, analyzing more than 500 genes on DNA / RNA level. Patients will be treated based on the molecular characteristics of the tumor cells.
- Conditions
- Rare Malignant Neoplasm
- Being tested
- Imatinib, Trametinib, Dabrafenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
imatinib treatment based on molecular alterations
TrametinibDrug
According to biomarkers
DabrafenibDrug
According to biomarkers
| Study group | Role | What they receive |
|---|---|---|
| treatment according to genetic alterations | Experimental | treatment according to genetic alterations Receives: Drug: Imatinib; Drug: Trametinib; Drug: Dabrafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological response evaluation at 16 weeks of treatment
Standard radiological response evaluation, like RECIST criteria.
Measured: 16 weeks
Secondary outcomes (1)
Molecular analyses predicting responses
Sequencing of tumor material and blood samples
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start20 Mar 2025
- Primary completion30 Nov 2033 (estimated)
- Study completion1 Aug 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rare Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- simon two stage model
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Stavanger HF, University Hospital of North Norway, StOlavs Hospital, Nordlandssykehuset HF, Helse Nord-Trøndelag HF, Sorlandet Hospital HF, Møre og Romsdal Hospital Trust, The Hospital of Vestfold, Helse Fonna, Haukeland University Hospital, Sykehuset Ostfold, Helse Forde, Sykehuset Innlandet HF
- Responsible party
- Principal investigator, Åslaug Helland, Oslo University Hospital
- Investigators
- Sigbjørn Smeland, MD PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119789
- Sponsor's protocol ID
- MATRIX-Rare
- Acronym
- MATRIX-Rare
- Status last verified
- Mar 2025
- First submitted
- 25 May 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MATRIX Clinical Studies of Precision Cancer Therapy for Rare Cancers
- ClinicalTrials.gov ID
- NCT06119789
- Acronym / sponsor ID
- MATRIX-Rare / MATRIX-Rare
- Conditions
- Rare Malignant Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Helse Stavanger HF, University Hospital of North Norway, StOlavs Hospital, Nordlandssykehuset HF, Helse Nord-Trøndelag HF, Sorlandet Hospital HF, Møre og Romsdal Hospital Trust, The Hospital of Vestfold, Helse Fonna, Haukeland University Hospital, Sykehuset Ostfold, Helse Forde, Sykehuset Innlandet HF
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 30 Nov 2033 (estimated)
- Study completion
- 1 Aug 2036 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some rare cancers are hard-to-treat and patients have a poor prognosis. It is known that some of these patients have targetable molecular alterations, and some benefit from targeted drugs. However in many cases these drugs are not approved for the rare cancers.
In this study the aim is to do advanced molecular diagnostics to identify possible targets for therapy, and to treat accordingly.
Detailed description
All patients will have the tumour cells diagnosed with a large genepanel, analyzing more than 500 genes on DNA / RNA level. Patients will be treated based on the molecular characteristics of the tumor cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- simon two stage model
| Arm | Type | Receives |
|---|---|---|
| treatment according to genetic alterations | Experimental | Drug: Imatinib, Drug: Trametinib, Drug: Dabrafenibtreatment according to genetic alterations |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ECOG 0-2,
- identified biomarker,
- reasonable biochemistry
Key exclusion criteria (2 listed)
- ECOG 3-5
- serious other diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imatinibimatinib treatment based on molecular alterations | Drug | treatment according to genetic alterations |
| TrametinibAccording to biomarkers | Drug | treatment according to genetic alterations |
| DabrafenibAccording to biomarkers | Drug | treatment according to genetic alterations |
Primary outcome
Radiological response evaluation at 16 weeks of treatment
Time frame: 16 weeks
Standard radiological response evaluation, like RECIST criteria.
1 secondary outcome
Molecular analyses predicting responses
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathinka Slørdahl, MD PhD contact
Sigbjørn Smeland, MD PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib, Trametinib and Dabrafenib in people with Rare Malignant Neoplasm, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Åslaug Helland, MD PhD (+4795940863, ahelland@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological response evaluation at 16 weeks of treatment (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.