DETERMINE Trial Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations

Sponsor
Cancer Research UK
Study ID
NCT06988475
Phase
PHASE2/PHASE3
Status
Recruiting

Conditions

  • Cancer
  • Gastric Cancer
  • Glioma
  • Haematological Malignancy
  • Malignancy
  • Malignant Neoplasm
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Neuroblastoma
  • Soft Tissue Sarcoma
  • Solid Tumour

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capmatinib — DRUG
    Patients will be administered capmatinib orally at a daily dose of 800 mg consisting of 400 mg (two 200mg tablets) twice daily. Each cycle of treatment will consist of 28 days and patients may continue on treatment until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent.

Study Details

This clinical trial is looking at a drug called capmatinib. Capmatinib is approved as standard of care treatment for adult patients with certain types of lung cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Capmatinib works in patients with lung cancer with a particular mutation in their cancer known as a METex14 skipping mutation. Investigators now wish to find out if it will be useful in treating patients with other cancer types which have the same mutation or other specific mutations or changes which take place in the MET gene. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.

Key Dates

First listed
May 23, 2025
Start date
Nov 19, 2024
Status verified
Nov 2025
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm 06: Capmatinib
    This capmatinib treatment arm is for adult partients with cancers harbouring MET dysregulations.

Primary Outcome Measure

Objective Response (OR) [ Time Frame: Disease assessments to be performed up to 24 weeks from the start of trial treatment. ]

Central Contacts

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