Study on Trametinib for Cancers with GNAQ or GNA11 Genetic Changes
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04439357
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 GNAQ or GNA11 mutations. The study aims to find out if trametinib can block certain proteins that these cancer cells need to grow.
Patient Parameters
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Program Overview
This study is exploring whether the drug trametinib can effectively treat cancers that have specific genetic changes known as GNAQ or GNA11 mutations. Trametinib works by blocking proteins called MEK1 and MEK2, which may be necessary for the growth of cancer cells with these mutations. Researchers hope to determine if trametinib can shrink these types of cancers 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.
Participants in the study will take trametinib by mouth once a day in 28-day cycles. They will continue this treatment as long as their cancer does not worsen and they do not experience severe side effects. 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 specific treatment study.
- Must have cancer with GNAQ or GNA11 mutations, as identified in the main MATCH study.
- Must have a recent electrocardiogram (ECG) showing no serious heart rhythm problems or high blood pressure that cannot be controlled with medication.
- Must have a recent heart function test showing normal heart pumping ability.
- Must have stopped any previous monoclonal antibody 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), and must have an eye exam before starting the study.
- Cannot have previously taken other MEK inhibitors, including trametinib or similar drugs.
- Cannot have uveal melanoma.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
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