MATRIX-Rare: Precision Cancer Therapy in Rare Cancers

Sponsor
Oslo University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06119789
Collaborator
Helse Stavanger HF (Other), University Hospital of North Norway (Other), StOlavs Hospital (Other), Nordlandssykehuset HF (Other), Helse Nord-Trøndelag HF (Other), Sorlandet Hospital HF (Other), Møre og Romsdal Hospital Trust (Other), The Hospital of Vestfold (Other), Helse Fonna (Other), Haukeland University Hospital (Other), Sykehuset Ostfold (Other), Helse Forde (Other), Sykehuset Innlandet HF (Other)
96
1
117

Study Details

Study Description

Brief 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.

In this study the aim is to do advanced molecular diagnostics to identify possible targets for therapy, and to treat accordingly.

Condition or Disease Intervention/Treatment Phase
Phase 2

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

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
simon two stage modelsimon two stage model
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The MATRIX Clinical Studies of Precision Cancer Therapy for Rare Cancers
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2027
Anticipated Study Completion Date :
Aug 1, 2033

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment according to genetic alterations

treatment according to genetic alterations

Drug: Imatinib
imatinib treatment based on molecular alterations

Outcome Measures

Primary Outcome Measures

  1. Radiological response evaluation at 16 weeks of treatment [16 weeks]

    Standard radiological response evaluation, like RECIST criteria.

Secondary Outcome Measures

  1. Molecular analyses predicting responses [2 years]

    Sequencing of tumor material and blood samples

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ECOG 0-2,

  • identified biomarker,

  • reasonable biochemistry

Exclusion Criteria:
  • ECOG 3-5

  • serious other diseases

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Oslo University Hospital
  • 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

Investigators

  • Principal Investigator: Åslaug Helland, MD PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Åslaug Helland, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT06119789
Other Study ID Numbers:
  • MATRIX-Rare
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023