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

Conditions

• Advanced Solid Tumors Which Are cMET-dependent

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Capmatinib — DRUG
  Tablet for oral use; 150 mg, 200 mg; twice a day
• Nazartinib — DRUG
  Capsule for oral use; 25 mg, 50 mg; once a day
• Gefitinib — DRUG
  tablets for oral use; 250mg; once a day
• Osimertinib — DRUG
  Tablets for oral use; 40 mg, 80 mg; once a day.

Study Details

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

Key Dates

Start date

Aug 23, 2017

Status verified

Jun 2026

Primary completion

Jul 30, 2027

Completion

Jul 30, 2027

Study Design

Enrollment

29 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Capmatinib
  Starting dose of study treatment for patients in this protocol should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted.
• Experimental: Capmatinib + Nazartinib
  Starting dose of the study treatment for patients should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted.
• Experimental: Capmatinib + Gefitinib
  Starting dose of the study treatment for patients in this protocol should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted.
• Experimental: Capmatinib + Osimertinib
  Starting dose of the study treatment for patients in this protocol should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted.

Primary Outcome Measure

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Day 1 up to 10 years, assessed every 12 weeks ]

Locations (1)

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