RecruitingPhase 2NCT05512208

A Phase 2 Study of Avutometinib (VS-6766) Plus Defactinib

A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) Plus Defactinib (FAK Inhibitor) in Recurrent Gynecological Cancers (DURAFAK)


Sponsor

University of Oklahoma

Enrollment

55 participants

Start Date

Feb 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research is to test the effectiveness and safety of the study drugs (VS-6766 and defactinib), and see what effects (good and bad) these drugs have on the patients with endometrioid cancer, mucinous ovarian cancer, high-grade serous ovarian cancer, or solid gynecological cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study tests a combination of two targeted cancer drugs — avutometinib and defactinib — for women with gynecological cancers (including ovarian, endometrial, and other solid gynecological cancers) that have specific gene mutations (RAS, BRAF, or NF-1). These mutations make cancer cells grow in a certain way that may be blocked by this drug combination. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with a gynecological cancer (such as ovarian, endometrial, or mucinous ovarian carcinoma) - Your tumor has been tested and found to have mutations in RAS, BRAF, NF-1, or related pathways - You have received prior treatment and your cancer has progressed or returned - Archival tumor tissue is available for testing **You may NOT be eligible if...** - Your tumor does not have the required mutations - You have significant liver, heart, or lung problems - You have uncontrolled brain metastases - You are pregnant or breastfeeding - You have received prior treatment with MEK inhibitors or FAK inhibitors Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAvutometinib (VS-6766) + defactinib

Avutometinib (VS-6766): will be administered at 3.2 mg orally twice a week Defactinib: will be administered at 200 mg orally twice a day (BID). Treatment will be for 3 weeks, followed by a 1-week rest period, in each 4-week (28 day) cycle.


Locations(4)

AdventHealth

Orlando, Florida, United States

Louisiana State University Medical Center New Orleans

New Orleans, Louisiana, United States

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05512208


Related Trials