NCT06072781 A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
| NCT ID | NCT06072781 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Verastem, Inc. |
| Condition | Low Grade Serous Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2024-03-18 |
| Primary Completion | 2028-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 270 participants in total. It began in 2024-03-18 with a primary completion date of 2028-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 progressed on a prior platinum-based therapy.
Eligibility Criteria
Inclusion Criteria: Patients may be eligible for inclusion in the study if they meet the following criteria: 1. Histologically proven LGSOC (ovarian, fallopian, peritoneal) 2. Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test. 3. Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole. 4. Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease. 5. Measurable disease according to RECIST v1.1. 6. An Eastern Cooperative Group (ECOG) performance status ≤ 1. 7. Adequate organ function. 8. Adequate recovery from toxicities related to prior treatments. 9. For patients with reproductive potential, a negative pregnancy test must be confirmed and agreement to use highly effective method of contraceptive. 10. Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria: Patients will be excluded from the study if they meet any of the following criteria: 1. Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy. 2. Co-existing high-grade serous ovarian cancer or mixed histology. 3. Prior treatment with avutometinib, defactinib, or other FAK inhibitors. 4. History of prior malignancy with recurrence \<3 years from the time of enrollment. 5. Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week of the first dose of study intervention. 6. Symptomatic brain metastases requiring steroids or other interventions, known leptomeningeal metastases, or spinal cord compression. 7. An active skin disorder that has required systemic therapy within one year of the first dose of study intervention. 8. History of medically significant rhabdomyolysis. 9. For subjects with prior MEK or RAF exposure, Grade 4 toxicity is deemed related to the MEK inhibitor. 10. Symptomatic bowel obstruction within 3 months of the first dose of study intervention 11. Concurrent ocular disorders. 12. Concurrent heart disease or severe obstructive pulmonary disease. 13. Active or past medical history of interstitial lung disease/pneumonitis, including drug-induced or radiation pneumonitis, pulmonary fibrosis, or adult respiratory distress syndrome (ARDS). 14. Subjects with the inability to swallow oral medications. 15. 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. 16. Pregnant or breastfeeding. 17. Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.
Contact & Investigator
Rachel Grisham, MD
PRINCIPAL INVESTIGATOR
GOG Foundation
Frequently Asked Questions
Who can join the NCT06072781 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Low Grade Serous Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06072781 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 270 participants.
Is NCT06072781 currently recruiting?
Yes, NCT06072781 is actively recruiting participants. Contact the research team at RAMP301TrialSupport@verastem.com for enrollment information.
Where is the NCT06072781 trial being conducted?
This trial is being conducted at Phoenix, United States, Little Rock, United States, Los Angeles, United States, Sacramento, United States and 11 additional locations.
Who is sponsoring the NCT06072781 clinical trial?
NCT06072781 is sponsored by Verastem, Inc.. The principal investigator is Rachel Grisham, MD at GOG Foundation. The trial plans to enroll 270 participants.
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