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

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.

ClinicalTrials.gov Identifier: NCT03040973

Novartis Reference Number: CINC280A2X02B

Last Update: Jan 30, 2023

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Advanced Solid Tumors Which Are cMET-dependent

Phase

Phase 2

Overall status

Recruiting

Start date

Jul 04, 2017

Completion date

Jul 30, 2027

Gender

All

Age(s)

(Child, Adult, Older Adult)

Interventions

Drug

Capmatinib

Tablet for oral use; 150 mg, 200 mg; twice a day

Drug

Nazartinib

Capsule for oral use; 25 mg, 50 mg; once a day

Drug

Gefitinib

tablets for oral use; 250mg; once a day

Drug

Osimertinib

Tablets for oral use; 40 mg, 80 mg; once a day.

Eligibility Criteria

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.

Exclusion criteria:

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

Study Locations

United States

Massachusetts General Hospital MGH Cancer Center

Recruiting

Boston, 02114 - Massachusetts

Contact: Aminta Kendall Scott - [email protected] - Rebecca Heist

United States

Belgium