Thinking of joining a study?

Register your interest

Become a volunteer?

NCT03040973 | RECRUITING | Advanced Solid Tumors Which Are cMET-dependent

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
Sponsor:

Novartis Pharmaceuticals

Brief 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

Condition or disease

Advanced Solid Tumors Which Are cMET-dependent

Intervention/treatment

Capmatinib

Nazartinib

Gefitinib

Osimertinib

Phase

PHASE2

Detailed Description:

This is an open-label, multi-center, rollover study to assess long-term safety in participants who have completed a prior Novartis-sponsored study, that have fulfilled the eligibility requirements and are judged by the Investigator to benefit from continued treatment with capmatinib given as monotherapy or in combination with other treatments or with the combination treatment alone. There will be no screening period for this study. After providing informed consent, all eligible participants will begin their treatment within the rollover study. Participants should return to the study center for resupply of the study medication/s and for safety assessment following the usual local practice. During a public health emergency as declared by local or regional authorities (i.e. pandemic, epidemic or natural disaster) that limits or prevents on-site study visits, alternative methods of providing continuing care may be implemented by the Investigator as the situation dictates. Participants will continue to be treated until they are no longer benefitting from the study treatment in the opinion of the treating physician, develop unacceptable toxicities that preclude further treatment with the study treatment, disease progression, withdrawal of consent, discontinuation at the discretion of the Investigator, initiation of new anticancer therapy, until the study treatment is commercially available and reimbursed or/and available under any other local mechanism (such as compassionate use, named patient program) for the appropriate indication and/or discontinuation for any other reason. Participants receiving capmatinib as part of a combination therapy could continue treatment only with capmatinib or with the combination treatment as single agent in case one of the two compounds is permanently discontinued, if in the opinion of the treating physician they are still benefitting from the treatment. A patient will reach the end of rollover study when study treatment is permanently discontinued and the end of treatment visit has been performed. All participants will be followed up for safety for 30 days after the last dose of study treatment or until SAE is resolved as required, whichever is later. The study is expected to remain open for up to 10 years or until such time that all enrolled participants no longer need treatment with study treatment(s) or Novartis decides to stop the development program, whichever comes first.

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : An Open-label, Multi-center, Global, Rollover Study for Patients Who Have Previously Been Treated With Capmatinib (INC280) as Monotherapy or in Combination in a Novartis Sponsored Trial.
Actual Study Start Date : 2017-07-04
Estimated Primary Completion Date : 2027-07-30
Estimated Study Completion Date : 2027-07-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion criteria
  • 1. 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).
  • 2. Participant is currently deriving clinical benefit from study treatment as determined by the Investigator
  • 3. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures
  • 4. 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.
  • Exclusion criteria
    • 1. 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)
    • 2. Pregnant or nursing (lactating) women
    • 3. 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:
    • 4. Concurrent participation in another clinical study other than a parent clinical study
    • 5. 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
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

Location Details

NCT03040973

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

ACTIVE NOT RECRUITING

Belgium,

Novartis Investigative Site

Leuven, Belgium, 3000

COMPLETED

Canada, Alberta

Novartis Investigative Site

Edmonton, Alberta, Canada, T6G 1Z2

RECRUITING

China, Shanghai

Novartis Investigative Site

Shanghai, Shanghai, China, 200433

RECRUITING

China, Yunnan

Novartis Investigative Site

Kunming, Yunnan, China, 650106

COMPLETED

Denmark,

Novartis Investigative Site

Copenhagen, Denmark, DK-2100

COMPLETED

France, Cote D Or

Novartis Investigative Site

Dijon, Cote D Or, France, 21034

WITHDRAWN

Germany,

Novartis Investigative Site

Dresden, Germany, 01307

ACTIVE NOT RECRUITING

Germany,

Novartis Investigative Site

Hannover, Germany, 30625

ACTIVE NOT RECRUITING

Germany,

Novartis Investigative Site

Cologne, Germany, 50937

ACTIVE NOT RECRUITING

Italy, MI

Novartis Investigative Site

Milano, MI, Italy, 20141

COMPLETED

Italy, PG

Novartis Investigative Site

Perugia, PG, Italy, 06129

COMPLETED

Korea, Republic of,

Novartis Investigative Site

Seoul, Korea, Republic of, 03080

COMPLETED

Korea, Republic of,

Novartis Investigative Site

Seoul, Korea, Republic of, 05505

WITHDRAWN

Korea, Republic of,

Novartis Investigative Site

Seoul, Korea, Republic of, 05505

ACTIVE NOT RECRUITING

Singapore,

Novartis Investigative Site

Singapore, Singapore, 119074

COMPLETED

Spain,

Novartis Investigative Site

Madrid, Spain, 28040