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Kinase Inhibitor

Capmatinib Safety for Cancer

Phase 2
Recruiting
Led By Toni Wozniak, MD
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is currently receiving capmatinib treatment within Novartis-sponsored study eligible for transition to rollover study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to 10 years, assessed every 12 weeks
Awards & highlights

Study Summary

This trial is to study the long-term safety of a drug called capmatinib, which is given to patients who are judged to benefit from the treatment.

Who is the study for?
This trial is for patients who are already part of a Novartis study and benefit from continuing Capmatinib alone or with other treatments. It's not for pregnant women, those able to become pregnant without effective contraception, or anyone receiving live vaccines recently.Check my eligibility
What is being tested?
The trial continues the use of Capmatinib, either by itself or combined with Nazartinib, Gefitinib, Osimertinib. The goal is to assess long-term safety and effects when these drugs are used beyond the initial study period.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants in previous trials may have experienced issues that could include typical drug reactions like nausea, fatigue, skin problems or more serious conditions depending on individual health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently on capmatinib treatment in a Novartis study and can move to another study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to 10 years, assessed every 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to 10 years, assessed every 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Trial Design

4Treatment groups
Experimental Treatment
Group I: Capmatinib + OsimertinibExperimental Treatment2 Interventions
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.
Group II: Capmatinib + NazartinibExperimental Treatment2 Interventions
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.
Group III: Capmatinib + GefitinibExperimental Treatment2 Interventions
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.
Group IV: CapmatinibExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capmatinib
FDA approved
Gefitinib
2005
Completed Phase 3
~2440
Osimertinib
2017
Completed Phase 4
~1010

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,853 Previous Clinical Trials
4,197,438 Total Patients Enrolled
Toni Wozniak, MDPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute

Media Library

Capmatinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03040973 — Phase 2
Solid Tumors Research Study Groups: Capmatinib, Capmatinib + Nazartinib, Capmatinib + Gefitinib, Capmatinib + Osimertinib
Solid Tumors Clinical Trial 2023: Capmatinib Highlights & Side Effects. Trial Name: NCT03040973 — Phase 2
Capmatinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03040973 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people total will be taking part in this clinical trial?

"That is correct. The clinical trial, which was first posted on July 4th 2017 and last edited on October 5th 2020, appears to be actively recruiting patients. Currently, the study needs 40 individuals between its 2 planned locations."

Answered by AI

When will capmatinib be available for public use?

"Capmatinib's safety is supported by some data, but as this is only a Phase 2 trial, there is no clinical evidence yet of the medication's efficacy. Therefore, we gave it a score of 2."

Answered by AI

Are patients being enrolled in this clinical trial at present?

"The clinical trial is actively recruiting patients, as shown by the updated information on clinicaltrials.gov. The trial was originally posted on 7/4/2017, and the most recent update was 10/5/2022. The study requires 40 patients from 2 locations."

Answered by AI

Are there other similar medical studies that have tested the effects of capmatinib?

"44 clinical trials are investigating the efficacy of capmatinib with 17 of them in Phase 3. Most of these medical studies are taking place in Chuo-Ku, Tokyo; however, there are 873 research sites for this drug globally."

Answered by AI
~13 spots leftby Jul 2027