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New treatment option for Solid Tumour
Official title DETERMINE Trial Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations
ClinicalTrials.gov ID: NCT06988475
What this study is testing
What is Capmatinib?
Capmatinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for solid tumour.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 06 (CAPMATINIB)...
- \ When capmatinib-specific inclusion/
You likely can't join if
- or precautions below differ from those specified in the Master Protocol, the capmatinib-specific criteria will take precedence. Inclusion criteria...
- Have a negative serum or urine pregnancy test before enrolment, and
- Agree to use one form of highly effective birth control method (a method that can achieve a failure rate of \<1% when used consistently and...
- Agree to take measures not to father children by using a barrier method of contraception (e.g. condom) or sexual abstinence.
- Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly...
- Male patients with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom) to prevent drug exposure...
See the full eligibility criteria
- THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 06 (CAPMATINIB) OUTLINED BELOW\
- \ When capmatinib-specific inclusion/
- or precautions below differ from those specified in the Master Protocol, the capmatinib-specific criteria will take precedence. Inclusion criteria: A. Confirmed diagnosis of a MET-positive malignancy using an...
- Have a negative serum or urine pregnancy test before enrolment, and
- Agree to use one form of highly effective birth control method (a method that can achieve a failure rate of \<1% when used consistently and correctly), such as: I. combined (oestrogen and progestogen containing)...
- Agree to take measures not to father children by using a barrier method of contraception (e.g. condom) or sexual abstinence.
- Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception, as in criterion C above.
- Male patients with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom) to prevent drug exposure of the foetus or neonate. All male patients must refrain from donating...
- Unstable angina within three months prior to screening
- Myocardial infarction within three months prior to screening
- History of documented congestive heart failure (New York Heart Association functional classification III-IV)
- Uncontrolled hypertension defined by a systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg, with or without antihypertensive medication. Initiation or adjustment of antihypertensive...
- Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within two weeks of the first dose of capmatinib, and patients with punctate CNS haemorrhages \<3 mm may be considered. G...
- Concomitant clinically significant cardiac arrhythmias (atrial and ventricular), e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
- History of familial long QT syndrome or known family history of Torsades de Pointes
- Resting QTcF (Corrected QT interval by Fridericia formula) ≥450 msec (male) or ≥460 msec (female) at screening ECG (as a mean of triplicate ECG) H. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic)...
- CD4 count ≥350/μL;
- undetectable viral load;
- receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and
- no HIV/ acquired immune deficiency syndrome-associated opportunistic infection in the last 12 months. M. Known hypersensitivity to any of the excipients of capmatinib. N. Patients with symptomatic central nervous system...
The study team makes the final eligibility decision.
Where it's taking place
- Belfast, United Kingdom
- Birmingham, United Kingdom
- Bristol, United Kingdom
- Cambridge, United Kingdom
- Cardiff, United Kingdom
- Edinburgh, United Kingdom
- Glasgow, United Kingdom
- Leicester, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Metropolitan Borough of Wirral, United Kingdom
- Newcastle, United Kingdom
- Oxford, United Kingdom
- Sheffield, United Kingdom
- Southampton, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belfast, United Kingdom; Birmingham, United Kingdom; Bristol, United Kingdom; Cambridge, United Kingdom; Cardiff, United Kingdom; Edinburgh, United Kingdom and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.