Actively Recruiting
A Phase 2 Study of Avutometinib (VS-6766) Plus Defactinib
Led by University of Oklahoma · Updated on 2025-10-22
55
Participants Needed
4
Research Sites
355 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
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.
CONDITIONS
Official 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 solid gynecological cancers) with mutated RAS, BRAF (type I, II, or III), NF-1 loss of function, or RAS activation
- Available mutation status from prior next-generation sequencing or molecular testing reviewed by the Principal Investigator
- Adequate pathology material available before treatment to confirm diagnosis
- Tumor with known mutation or activation status determined from prior testing; archival tumor tissue less than 5 years old or fresh biopsy samples must be available
- Disease progression or recurrence after at least one prior systemic therapy for metastatic disease
- Measurable disease according to RECIST 1.1 criteria
- Eastern Cooperative Group (ECOG) performance status of 2 or less
- Adequate organ function including hematologic, hepatic, renal, coagulation, albumin, creatine phosphokinase, and cardiac function as defined by laboratory parameters
- Baseline QTc interval less than 460 ms unless bundle branch block present
- Recovery from prior treatment toxicities to at least Grade 1 except alopecia and peripheral neuropathy Grade 2 or less
- Agreement to use highly effective contraception during the trial and for 1 month after last dose for females with reproductive potential
You will not qualify if you...
- Systemic anti-cancer therapy within 4 weeks before first study dose
- Prior exposure to MEK or RAF inhibitors
- Low-grade serous ovarian cancer
- History of prior malignancy with recurrence less than 3 years ago except certain skin, bladder, and cervical cancers with no evidence of disease for 1 year
- Candidates for debulking surgery
- Major surgery within 4 weeks, minor surgery within 2 weeks, or palliative radiotherapy within 1 week before first dose
- Treatment with warfarin unless switched to other anticoagulants
- Use of strong CYP2C9, CYP3A4, or P-glycoprotein inhibitors or inducers within 14 days before or during study
- Symptomatic brain metastases requiring steroids or intervention
- Known active SARS-CoV-2 infection within 28 days before first dose
- Active hepatitis B, hepatitis C, or HIV infection requiring therapy
- Active skin disorders needing systemic therapy within past year
- History of rhabdomyolysis
- Certain ocular disorders including glaucoma, retinal vein occlusion risk factors, and serious ocular surface inflammatory conditions
- Significant cardiac or pulmonary disease
- Inability to swallow oral medications or gastrointestinal absorption issues
- History of hypersensitivity to study drug ingredients
- Pregnant or breastfeeding females
- Any other medical condition posing high risk for toxicity per investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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