Status:
RECRUITING
A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
Lead Sponsor:
Verastem, Inc.
Collaborating Sponsors:
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Conditions:
Low Grade Serous Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progr...
Detailed Description
This international, randomized, open-label, Phase 3 study will compare the investigational combination of avutometinib plus defactinib versus Investigator's Choice of Treatments (ICT) in patients with...
Eligibility Criteria
Inclusion
- Patients may be eligible for inclusion in the study if they meet the following criteria:
- Histologically proven LGSOC (ovarian, fallopian, peritoneal)
- Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test.
- Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole.
- Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
- Measurable disease according to RECIST v1.1.
- An Eastern Cooperative Group (ECOG) performance status ≤ 1.
- Adequate organ function.
- Adequate recovery from toxicities related to prior treatments.
- For patients with reproductive potential, a negative pregnancy test must be confirmed and agreement to use highly effective method of contraceptive.
- Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion
- Patients will be excluded from the study if they meet any of the following criteria:
- Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
- Co-existing high-grade serous ovarian cancer or mixed histology.
- Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
- History of prior malignancy with recurrence \<3 years from the time of enrollment.
- Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week of the first dose of study intervention.
- Symptomatic brain metastases requiring steroids or other interventions, known leptomeningeal metastases, or spinal cord compression.
- An active skin disorder that has required systemic therapy within one year of the first dose of study intervention.
- History of medically significant rhabdomyolysis.
- For subjects with prior MEK or RAF exposure, Grade 4 toxicity is deemed related to the MEK inhibitor.
- Symptomatic bowel obstruction within 3 months of the first dose of study intervention
- Concurrent ocular disorders.
- Concurrent heart disease or severe obstructive pulmonary disease.
- Active or past medical history of interstitial lung disease/pneumonitis, including drug-induced or radiation pneumonitis, pulmonary fibrosis, or adult respiratory distress syndrome (ARDS).
- Subjects with the inability to swallow oral medications.
- History of hypersensitivity to any of the active agents or ingredients of study intervention: peanut, soya, polyoxyl castor oil, etcetc.). Prior hypersensitivity to anthracyclines or anthracenediones if the use of pegylated liposomal doxorubicin (PLD) is planned.
- Pregnant or breastfeeding.
- Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.
Key Trial Info
Start Date :
March 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 9 2031
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT06072781
Start Date
March 18 2024
End Date
February 9 2031
Last Update
November 14 2025
Active Locations (105)
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1
HonorHealth
Phoenix, Arizona, United States, 85016
2
University of Arkansas
Little Rock, Arkansas, United States, 72205
3
UCLA Health
Los Angeles, California, United States, 90095
4
UC Davis
Sacramento, California, United States, 95817