Precision Cancer Therapy in Rare Cancers

NCT06119789 | Recruiting Phase 2 DMC

• 1 other identifier: MATRIX-Rare
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Rare Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Radiological response evaluation at 16 weeks of treatment

  Standard radiological response evaluation, like RECIST criteria.

  16 weeks

Secondary Outcomes (1)

• Molecular analyses predicting responses

  2 years

Study Arms (1)

treatment according to genetic alterations

EXPERIMENTAL

treatment according to genetic alterations

Drug: Imatinib; Drug: Trametinib; Drug: Dabrafenib

Interventions

Imatinib DRUG

imatinib treatment based on molecular alterations

treatment according to genetic alterations

Trametinib DRUG

According to biomarkers

treatment according to genetic alterations

Dabrafenib DRUG

According to biomarkers

treatment according to genetic alterations

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG 0-2,
• identified biomarker,
• reasonable biochemistry

You may not qualify if:

• ECOG 3-5
• serious other diseases

Sponsors & Collaborators

• Oslo University Hospital: lead
• Helse Stavanger HF: collaborator
• University Hospital of North Norway: collaborator
• StOlavs Hospital: collaborator
• Nordlandssykehuset HF: collaborator
• Helse Nord-Trøndelag HF: collaborator
• Sorlandet Hospital HF: collaborator
• Møre og Romsdal Hospital Trust: collaborator
• The Hospital of Vestfold: collaborator
• Helse Fonna: collaborator
• Haukeland University Hospital: collaborator
• Sykehuset Ostfold: collaborator
• Helse Forde: collaborator
• Sykehuset Innlandet HF: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0310, Norway

RECRUITING

MeSH Terms

Interventions

Imatinib Mesylate; trametinib; dabrafenib

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Sigbjørn Smeland, MD PhD

  Oslo University Hospital

  STUDY CHAIR

Central Study Contacts

Åslaug Helland, MD PhD

CONTACT

+4795940863; ahelland@medisin.uio.no

Kathinka Slørdahl, MD PhD

CONTACT

katslo@ous-hf.no

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: simon two stage model

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: November 7, 2023
• Study Start: March 20, 2025
• Primary Completion (Estimated): November 30, 2033
• Study Completion (Estimated): August 1, 2036
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)