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

Launched by NOVARTIS PHARMACEUTICALS · Jan 31, 2017

Keywords

ClinConnect Summary

This clinical trial is designed for patients with advanced solid tumors that rely on a specific protein called cMET for growth. The study aims to allow patients who have already been receiving a treatment called capmatinib in a previous Novartis-sponsored trial to continue their treatment. Participants may receive capmatinib on its own or in combination with other treatments, depending on what their doctor believes will help them the most.

To be eligible for this study, patients must currently be receiving capmatinib as part of the previous trial and be experiencing benefits from it. They should also be willing to keep up with scheduled appointments and follow the treatment plan. It’s important to know that patients cannot join if they are facing unresolved side effects from the treatment or if they are pregnant or nursing. Throughout the trial, participants will be closely monitored to ensure their safety and well-being as they continue their treatment.

Gender

ALL

Eligibility 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