Study on Trametinib for Treating Cancers with BRAF Genetic Changes
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04439279
This clinical trial is testing the drug trametinib to see if it can help shrink or stop the growth of cancers with specific genetic changes called BRAF mutations and fusions.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to find out if trametinib, a drug that may block certain proteins needed for cancer growth, can help reduce or stop the growth of cancers with BRAF genetic changes. Researchers are looking to see if trametinib can shrink these types of cancers or prevent them from getting worse.
Description
The main goal of this study is to see how many patients with advanced cancers respond to trametinib treatment. Researchers also want to know how many patients are still alive and have not seen their cancer progress after six months of treatment. They will also study how long it takes for the cancer to progress or for the patient to pass away. Additionally, the study will look for other markers that might predict how well the treatment works or why it might stop working.
Patients in the study will take trametinib by mouth once a day for 28 days in each cycle. These cycles will continue as long as the cancer does not progress and the patient can tolerate the treatment. After finishing the treatment, patients will have follow-up visits every three months for the first two years, and then every six months in the third year.
Eligibility Criteria
Inclusion Criteria
- Must meet the eligibility criteria from the main MATCH study before joining this sub-study.
- Must have a specific type of BRAF genetic change, either a non-V600 mutation or a BRAF fusion, identified through the MATCH study.
- Must have a recent electrocardiogram (ECG) showing no major heart issues, such as serious rhythm problems or uncontrolled high blood pressure.
- Must have a recent heart function test showing normal heart pumping ability.
- If previously treated with certain antibody therapies, must have stopped those treatments at least eight weeks before starting trametinib.
Exclusion Criteria
- Cannot have a history of lung diseases like interstitial lung disease or pneumonitis.
- Cannot be allergic to trametinib or similar drugs, or to dimethyl sulfoxide (DMSO).
- Cannot have a history or risk of a specific eye condition called retinal vein occlusion (RVO); an eye exam is needed before starting the study.
- Cannot have previously taken MEK inhibitors, including trametinib or similar drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.