Not recruiting

Study for Patients with cMET-Dependent Cancers to Continue Treatment with Capmatinib, Nazartinib, and Gefitinib

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with cMET-dependent cancers, which are a type of cancer that relies on a specific protein called cMET for growth. The study involves the use of a medication called capmatinib, also known by its code name INC280. Capmatinib is taken as a film-coated tablet and is designed to target and inhibit the activity of the cMET protein, potentially slowing down or stopping the growth of these cancers. In addition to capmatinib, the study also involves another medication called nazartinib, known by its code name EGF816, which is taken as a hard capsule. Another medication, gefitinib, is also part of the study and is taken as a film-coated tablet.

The purpose of this study is to evaluate the long-term safety of capmatinib when used alone or in combination with other treatments. Participants in this study have previously been treated with capmatinib in a Novartis-sponsored trial and are continuing their treatment in this study. The study will monitor the occurrence of any adverse events (AEs) or serious adverse events (SAEs) to ensure the safety of the treatment over an extended period.

Participants will continue their treatment with capmatinib, either alone or in combination with other medications, for a maximum period of 120 weeks. The study will involve regular visits to monitor the participants' health and any side effects they may experience. The goal is to ensure that the treatment remains safe and effective for those who are benefiting from it. This study is expected to continue until July 2027.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment in the study
Enrollment occurs after providing written informed consent. This consent confirms understanding and agreement to participate in the study.
Eligibility requires current treatment with capmatinib as a single agent or in combination, and deriving clinical benefit from the treatment.
Step 2
Treatment continuation
Continue taking capmatinib in the form of a film-coated tablet. The method of administration is oral.
The treatment may involve capmatinib alone or in combination with other medications such as nazartinib or gefitinib, depending on the previous treatment regimen.
Step 3
Regular monitoring
Attend scheduled visits for monitoring. These visits assess the long-term safety of the treatment by recording any adverse events (AEs) or serious adverse events (SAEs).
The frequency and severity of any side effects are evaluated during these visits.
Step 4
Study duration
The study is estimated to continue until July 30, 2027.
Participation involves adherence to the treatment plan and scheduled visits throughout the study duration.

Who can join the trial?

4 criteria

The participant must currently be receiving a treatment called capmatinib, either alone or with other treatments, as part of a specific study sponsored by Novartis.
The participant must be experiencing a positive effect or benefit from the study treatment, as determined by the study doctor.
The participant must be willing and able to attend scheduled visits, follow the treatment plans, and participate in any other study-related procedures.
The participant must provide written informed consent before joining the study and receiving the study medication. If the participant cannot provide written consent, it must be formally documented and witnessed, preferably by an independent trusted witness.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Verified
Medizinische Hochschule Hannover
Hanover, Germany

Trial locations

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Investigated drugs

Capmatinib (INC280) is a medication being studied for its long-term safety. It is used either alone or in combination with other treatments. This trial is focused on patients who have already been treated with this medication in previous studies. The goal is to monitor any adverse effects or serious adverse effects that may occur over an extended period.

What is already known about the treatment

Capmatinib – Capmatinib is administered orally in tablet form. It is currently being studied in clinical trials for its long-term safety and effectiveness, particularly in treating cMET-dependent malignancies. The medication works by inhibiting the cMET receptor, which is involved in the growth and spread of cancer cells. Capmatinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

cMET-dependent malignancies – These are types of cancers that rely on the cMET protein for growth and survival. The cMET protein is involved in signaling pathways that control cell growth, movement, and differentiation. When cMET is overactive or mutated, it can lead to uncontrolled cell division and tumor development. These malignancies can occur in various organs and tissues, depending on where the cMET pathway is disrupted. The progression of these cancers can vary, often involving the spread of cancer cells to other parts of the body. Understanding the role of cMET in these malignancies is crucial for developing targeted therapies.