Actively Recruiting
A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) Plus Defactinib (FAK Inhibitor) in Recurrent Gynecological Cancers (DURAFAK)
Led by University of Oklahoma · Updated on 2025-10-22
55
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of Oklahoma
Lead Sponsor
V
Verastem, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of the drugs Avutometinib (VS-6766) and defactinib in women with certain gynecological cancers, including endometrioid cancer, mucinous ovarian cancer, high-grade serous ovarian cancer, and other solid gynecological tumors. This is a Phase 2, open-label study designed to explore how these drugs affect patients with these cancers that have specific genetic mutations or activations related to RAS, BRAF, or NF-1. Participants will take Avutometinib orally twice a week at 3.2 mg and defactinib orally twice daily at 200 mg. Each treatment cycle lasts four weeks, with three weeks of medication followed by one week off. The study involves a single stage with parallel cohorts, and all treatments and procedures are conducted at multiple centers. Patients will visit the study sites regularly for assessments and treatment. During the study, participants will undergo physical examinations, vital sign checks, tumor size assessments, urine and blood tests, and evaluations for any side effects. The main outcome measured is the proportion of patients who show an objective response to the treatment over two years. Secondary outcomes include tracking side effects, duration of response, progression-free survival, disease control rate, and overall survival. The total participation period extends up to two years, during which safety and efficacy are closely monitored.
CONDITIONS
Brief Title
A Phase 2 Study of Avutometinib (VS-6766) Plus Defactinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects 18 years of age or older
- Histologically confirmed gynecological cancers (endometrioid, mucinous ovarian cancer, high-grade serous ovarian cancer, or other solid gynecological cancers) with mutated RAS, BRAF (type I, II, or III), NF-1 loss of function, or RAS activation
- Tumor mutation status confirmed by previous genetic or molecular testing with adequate pathology material available
- Evidence of progression or recurrence after at least one prior systemic therapy for metastatic disease including platinum therapy
- Measurable disease according to RECIST 1.1 criteria
- ECOG performance status of 0, 1, or 2
- Adequate organ function including blood counts, liver and kidney function, heart function (LVEF ≥55%), and normal QTc interval
- Recovery from prior treatment toxicities to at least Grade 1 (except alopecia and Grade ≤2 peripheral neuropathy)
- Agreement to use effective contraception during the trial and for one month after last dose of Avutometinib
You will not qualify if you...
- Systemic anti-cancer therapy within 4 weeks before starting study drugs
- Prior exposure to MEK or RAF inhibitors
- Low grade serous ovarian cancer diagnosis
- History of malignancy with recurrence less than 3 years prior, except certain treated skin or bladder cancers
- Candidates for debulking surgery as determined by their physician
- Recent major surgery within 4 weeks, minor surgery within 2 weeks, or palliative radiotherapy within 1 week before treatment
- Use of warfarin anticoagulant unless converted to other anticoagulants
- Use of strong CYP2C9, CYP3A4, or P-glycoprotein inhibitors or inducers within 14 days before or during treatment
- Symptomatic brain metastases requiring steroids or intervention
- Active infections such as symptomatic COVID-19, active hepatitis B, C, or HIV
- Active skin disorders requiring systemic treatment within past year
- History of rhabdomyolysis
- Certain eye disorders including glaucoma, retinal vein occlusion risk factors, or serious ocular inflammation
- Severe heart or lung diseases including recent heart attack or unstable angina
- Inability to swallow oral medications or impaired gastrointestinal absorption
- Allergy to study drug ingredients
- Pregnant or breastfeeding females
- Any other medical condition deemed unsafe by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 4-week cycles, each consisting of 3 weeks of treatment followed by 1 week of rest
Participants take the study drugs Avutometinib (VS-6766) and Defactinib orally according to the study schedule. They attend study visits where physical examinations, vital signs, tumor assessments, and urine and blood tests are conducted. Additional visits may be scheduled to assess side effects.
Multiple visits during each 4-week cycle as per study procedures
Trial Site Locations
Total: 4 locations
1
AdventHealth
Orlando, Florida, United States, 32804
Actively Recruiting
2
Louisiana State University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
3
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
4
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73117
Actively Recruiting
Research Team
S
SCC IIT Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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