Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiv… (NCT03040973) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone
United States, Belgium, Canada29 participantsStarted 2017-08-23
Plain-language summary
The purpose of this study is to assess long-term safety and provide continued study treatment access to eligible participants who are judged by the Investigator to benefit from continued treatment with capmatinib monotherapy or in combination with other treatments or with the combination treatment alone in a Novartis sponsored study
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant is currently receiving capmatinib treatment (within Novartis-sponsored study which is eligible and approved to transition participants to rollover study) as single agent or in combination or is receiving a combination treatment alone. This includes all participants treated with capmatinib in combination with other treatment that permanently discontinued capmatinib for any reason but are still receiving the combination treatment as single agent. In order to receive the combination treatment as single agent in the rollover study, the treatment needs to be not accessible to the participant outside a clinical trial (e.g. commercially not available or reimbursed).
. Participant is currently deriving clinical benefit from study treatment as determined by the Investigator
. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures
. Written informed consent obtained prior to enrolling in the rollover study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is only open to patients who were already in a previous Novartis capmatinib study, can you tell me whether my history with any prior capmatinib trial would make me eligible to continue treatment through this rollover program?
2The main thing this Phase 2 trial is measuring is safety and tolerability — not tumor response — so what does that mean for what we'd actually know about whether capmatinib is helping my specific cancer if I were to participate?
3Because this trial involves cMET-dependent tumors, can you test or confirm whether my tumor has a cMET alteration, and how confident are you in that result given my diagnosis?
4Since the trial is no longer actively recruiting and is described as 'active not recruiting,' does that mean the only people still in it are those already enrolled, and would that affect my ability to access capmatinib through this study at all?
5If this rollover trial isn't an option for me, are there other ways to access capmatinib — such as through a different clinical trial, expanded access, or approved use — that we should be considering instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timeframe: Day 1 up to 10 years, assessed every 12 weeks
. Participant is currently not receiving any study treatment due to unresolved toxicities for which study treatment dosing has been interrupted or permanently discontinued in the parent protocol (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow study treatment dosing to resume)
. Pregnant or nursing (lactating) women
. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for at least 7 days or following combination treatment parent trial recommendation (whichever is longer) of study treatment after stopping medication. Highly effective contraception methods include:
. Concurrent participation in another clinical study other than a parent clinical study
. Participants who received live vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, TY21a typhoid vaccines and COVID-19 vaccines) within 30 days prior to the first dose of study treatment