Precision Cancer Therapy in Rare Cancers (MATRIX-Rare)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rare Malignant Neoplasm
• Intervention / Treatment: Drug: Imatinib

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 Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Åslaug Helland; Phone Number: +4795940863; Email: aslaug.helland@gmail.com
• Study Contact Backup: Name: Elisa Bjørgo; Email: elisa@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• ECOG 3-5
• serious other diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment according to genetic alterations	Drug: Imatinib; imatinib treatment based on molecular alterations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological response evaluation at 16 weeks of treatment	Standard radiological response evaluation, like RECIST criteria.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular analyses predicting responses	Sequencing of tumor material and blood samples	2 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University Hospital of North Norway; Helse Stavanger HF; Haukeland University Hospital; Sorlandet Hospital HF; Sykehuset Innlandet HF; The Hospital of Vestfold; Helse Nord-Trøndelag HF; Helse Fonna; Møre og Romsdal Hospital Trust; Helse Forde; Nordlandssykehuset HF; Sykehuset Ostfold; StOlavs Hospital
• Investigators: Principal Investigator: Åslaug Helland, MD PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): August 1, 2033

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: MATRIX-Rare

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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