Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
ID06988475

DETERMINE Trial: Capmatinib Treatment in Adult Patients With Cancers Harboring MET Gene Dysregulations

Led by Cancer Research UK · Updated on 2025-11-24

30

Participants Needed

17

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Cancer Research UK

Lead Sponsor

U

University of Birmingham

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating capmatinib, a drug approved for certain lung cancers with a specific METex14 skipping mutation, to see if it is useful in treating other rare or common adult cancers that have mutations or changes in the MET gene. This trial is part of the DETERMINE program, which aims to match existing targeted therapies to rare cancers or cancers with specific genetic alterations, potentially expanding treatment options through the NHS and Cancer Drugs Fund. In this trial, adult patients with cancers harboring MET dysregulations will receive capmatinib orally at a dose of 800 mg daily (400 mg twice a day). Treatment cycles last 28 days, and patients will continue treatment until their disease progresses without benefit, they experience unacceptable side effects, or they choose to stop. Patients will have blood samples collected at various times during treatment and at the end of treatment. After treatment ends, they will be followed up every three months for two years. Participants will undergo screening that includes molecular testing of their tumor and biopsies or blood sample collections. Researchers will perform disease assessments regularly during treatment, typically every two cycles (each 28 days), and less frequently after 24 weeks. Outcomes measured include tumor response, clinical benefit, survival times, and quality of life surveys. Safety monitoring will continue for up to five years after treatment, and follow-up visits will assess participants every three months for two years to observe long-term effects.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of a MET-positive cancer using next-generation sequencing (including METex14 skipping, amplification, fusion, or activating mutation).
  • Adult patients aged 18 years or older.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and for seven days after treatment.
  • Male patients with partners of childbearing potential must agree to use barrier contraception and ensure partner uses effective birth control during and for seven days after treatment.
  • Ability and willingness to undergo a fresh biopsy at baseline and blood sample collection for research.
  • Adequate organ function based on blood tests as defined in the protocol.
Not Eligible

You will not qualify if you...

  • Diagnosis of non-small cell lung cancer (NSCLC) with METex14 skipping mutation or MET amplification.
  • Prior treatment with selective MET inhibitors or HGF-targeting therapy unless resistant and potentially sensitive to capmatinib.
  • Carcinomatous meningitis.
  • Other cancers diagnosed or treated within the last three years, except certain skin cancers and carcinoma in situ.
  • Interstitial lung disease or pneumonitis, including active pneumonitis on chest CT.
  • Uncontrolled or significant heart disease including recent unstable angina, heart attack, heart failure, or uncontrolled hypertension.
  • Recent cerebrovascular events within three months.
  • Significant ECG abnormalities posing safety risks.
  • Major surgery within four weeks before treatment (two weeks for brain surgery) or not recovered from surgery side effects.
  • Use of strong CYP3A inducers that cannot be stopped before and during treatment.
  • Conditions interfering with study conduct or drug absorption including serious gastrointestinal diseases.
  • Active infections including uncontrolled hepatitis B, C, or HIV unless controlled under therapy.
  • Known hypersensitivity to capmatinib ingredients.
  • Neurologically unstable symptomatic CNS metastases or recent steroid dose increases for CNS symptoms.
  • Use of enzyme-inducing anticonvulsants that cannot be stopped prior to treatment.
  • Pregnant or breastfeeding women or those planning pregnancy during and for seven days after treatment.
  • Recent live attenuated vaccine within 28 days before enrollment or planned during treatment or six months after last dose.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for biopsy and blood sample collection

Treatment

Duration - Repeated 28-day cycles until disease progression, unacceptable adverse events, or withdrawal of consent

Participants receive capmatinib orally daily in 28-day cycles until disease progression, unacceptable side effects, or withdrawal of consent. Blood samples are collected at various intervals during treatment and at the end of treatment.

Disease assessments every 2 cycles (every 8 weeks) and at end of treatment; blood sample collections at various intervals

Follow-up

Duration - Up to 2 years after treatment ends

After completing study treatment, participants are followed up every 3 months for 2 years to monitor health and survival.

Follow-up visits every 3 months

Trial Site Locations

Total: 17 locations

1

Belfast City Hospital

Belfast, United Kingdom, BT9 7AB

Actively Recruiting

2

University Hospital Birmingham

Birmingham, United Kingdom, B15 2TT

Actively Recruiting

3

Bristol Haematology and Oncology Centre

Bristol, United Kingdom, BS2 8ED

Actively Recruiting

4

Addenbrooke's Hospital

Cambridge, United Kingdom, CB2 OQQ

Not Yet Recruiting

5

Velindre Cancer Centre

Cardiff, United Kingdom, CF14 2TL

Actively Recruiting

6

Western General Hospital

Edinburgh, United Kingdom, EH4 2XU

Actively Recruiting

7

The Beatson Hospital

Glasgow, United Kingdom, G12 OYN

Actively Recruiting

8

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Actively Recruiting

9

University College London Hospital

London, United Kingdom, NW1 2BU

Actively Recruiting

10

Guy's Hospital

London, United Kingdom, SE1 9RT

Actively Recruiting

11

The Christie Hospital

Manchester, United Kingdom, M20 4BX

Actively Recruiting

12

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom, CH63 4JY

Actively Recruiting

13

Freeman Hospital

Newcastle, United Kingdom, NE7 7DN

Actively Recruiting

14

Churchill Hospital

Oxford, United Kingdom, OX3 7LE

Actively Recruiting

15

Western Park Hospital

Sheffield, United Kingdom, S10 2SJ

Actively Recruiting

16

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

Actively Recruiting

17

Royal Marsden Hospital

Sutton, United Kingdom, SM2 5PT

Actively Recruiting

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Research Team

A

Aida Sarmiento Castro

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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