Phase 2 Study of Avutometinib Plus Defactinib for Gynecological Cancers
This study is testing two drugs, Avutometinib (VS-6766) and defactinib, to see how well they work and if they are safe for women with certain gynecological cancers. These include endometrioid cancer, mucinous ovarian cancer, high-grade serous ovarian cancer, or other solid gynecological cancers. You may be able to join if your cancer has specific changes (mutations) in genes like RAS or BRAF, or a loss of NF-1 function. The study will look at how many patients respond to the treatment over two years. The drugs are taken by mouth for three weeks, followed by a one-week break, in each four-week cycle.
- Study design
- This is a Phase 2 study, meaning it's an early-stage study to see if the treatment is effective and safe. It plans to include 55 participants and is an open-label study, so both you and your doctors will know what treatment you are receiving.
- What's involved
- You will take the study drugs orally and attend regular study visits. These visits will include physical exams, checking vital signs, measuring your tumor size, and providing urine and blood samples. Additional visits may be needed to check for side effects.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main goal of the study is measured at 2 years, which suggests follow-up will occur for at least this long.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 2 Study of Avutometinib (VS-6766) Plus Defactinib
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- Christina Washington, MD · PRINCIPAL_INVESTIGATOR · OU Health Stephenson Cancer Center
Who to contact
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What this trial measures
- Proportion of Patients with objective response rate2 years
To evaluate the efficacy of Avutometinib (VS-6766) + defactinib in endometrioid, MOC, HGSOC and solid gynecological cancer patients with RAS/BRAF/NF1 mutations on confirmed overall response rate (ORR; partial response \[PR\] + complete response \[CR\] defined according to RECIST 1.1) as assessed by the investigator.