Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05512208

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)

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
55 (estimated)
Sponsor
University of Oklahoma · Academic / Other
Sex
Female
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

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.

Detailed description

This is a single-stage exploratory, Phase 2, multicenter, parallel cohort, open label study designed to evaluate efficacy and safety of VS-6766 + defactinib. Enrolled study patients will receive the study drugs (VS-6766 and defactinib) to take orally based on the study procedures. Patients will follow the study procedures and attend all the study visits where various procedures including physical examinations, vitals, assessing the size of the patient's tumor, and examination of urine and blood may take place. Additional visits may be done to assess any other side effects a patient's experiences.

Conditions

Interventions

TypeNameDescription
DRUGAvutometinib (VS-6766) + defactinibAvutometinib (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.

Timeline

Start date
2023-02-06
Primary completion
2027-12-01
Completion
2029-12-01
First posted
2022-08-23
Last updated
2025-10-22

Locations

4 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05512208. Inclusion in this directory is not an endorsement.