Testing Trametinib for Cancers with NF1 Genetic Changes (MATCH-Subprotocol S1)
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04439318
This study is exploring whether the drug trametinib can help shrink or stop the growth of cancers with a specific genetic change called an NF1 mutation. Trametinib works by blocking certain proteins that cancer cells need to grow.
Patient Parameters
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Program Overview
This phase II clinical trial is testing the effects of trametinib in patients whose cancer has a genetic change known as an NF1 mutation. Trametinib blocks proteins called MEK1 and MEK2, which may be necessary for cancer cell growth when an NF1 mutation is present. The researchers aim to find out if trametinib can shrink these types of cancer or stop them from growing.
Description
The main goal of this study is to see how many patients experience a reduction in their cancer size after taking trametinib. Researchers also want to know how many patients are still alive and have not seen their cancer grow after six months of treatment. They will also look at how long it takes for the cancer to progress or for the patient to pass away. Additionally, the study will explore other factors that might predict how well the treatment works, using various tests and imaging techniques.
Patients in the study will take trametinib by mouth once a day for 28 days. This cycle will repeat every 28 days as long as the cancer does not get worse 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 of the main MATCH study before joining this sub-study.
- Must have a specific genetic change called an NF1 mutation, as identified in the main MATCH study.
- Must have a heart test (ECG) within eight weeks before starting treatment and should not have serious heart issues like abnormal heart rhythms or high blood pressure that cannot be controlled.
- Must have a heart function test (ECHO or MUGA) within four weeks before starting treatment and should have normal heart function.
- If previously treated with certain antibody therapies, must have stopped those treatments at least eight weeks before starting trametinib.
- If diagnosed with glioblastoma, must have confirmed recurrent or worsening grade 4 glioma, as shown by specific brain scans.
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 and similar drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
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