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Clinical Trials in Ireland / NCT06072781
Recruiting Phase 3

A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer

NCT06072781 · tracked via the Priya Life Science Ireland tracker
Sponsor
Verastem, Inc.
Phase
Phase 3
Started
2024-03-18
Last updated
2026-08-14

Condition(s) studied

Low Grade Serous Ovarian Cancer

Investigational drug(s) / intervention(s)

avutometinibDefactinibPegylated liposomal doxorubicinPaclitaxelLetrozoleAnastrozole

avutometinib: Avutometinib: administered orally

Defactinib: Defactinib: administered orally

Pegylated liposomal doxorubicin: administered intravenously

Paclitaxel: administered intravenously

Letrozole: administered orally

Anastrozole: administered orally

Study 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

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (106)

FacilityCityRegionStatus
HonorHealth Phoenix Arizona Recruiting
University of Arkansas Little Rock Arkansas Recruiting
UCLA Health Los Angeles California Recruiting
UC Davis Sacramento California Recruiting
University of California, San Francisco San Francisco California Active Not Recruiting
Yale University New Haven Connecticut Recruiting
Florida Cancer Specialists - South Fort Myers Florida Recruiting
Mount Sinai Miami Beach Florida Recruiting
AdventHealth Orlando Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Florida Cancer Specialists Research East West Palm Beach Florida Recruiting
Winship Cancer Institute at Emory University Atlanta Georgia Recruiting
NorthShore University HealthSystem Evanston Illinois Recruiting
Louisiana State University New Orleans Louisiana Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland Recruiting
Karmanos Cancer Center Detroit Michigan Recruiting
Minnesota Oncology Hematology Minneapolis Minnesota Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Roswell Park Cancer Institute Buffalo New York Active Not Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Atrium Health Charlotte North Carolina Recruiting
Cleveland Clinic Foundation Cleveland Ohio Recruiting
Ohio State Hilliard Ohio Recruiting
University of Oklahoma Medical Center Oklahoma City Oklahoma Recruiting
Willamette Valley Cancer Institute Eugene Oregon Recruiting
Northwest Cancer Specialists Portland Oregon Recruiting
Asplundh Cancer Pavilion | Jefferson Health Philadelphia Pennsylvania Recruiting
Allegheny Health Network Pittsburgh Pennsylvania Recruiting
Texas Oncology Central Austin Texas Recruiting
Texas Oncology-Fort Worth Cancer Center Fort Worth Texas Recruiting
Houston Methodist Houston Texas Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Texas Oncology San Antonio Texas Recruiting
Texas Oncology The Woodlands Texas Recruiting
Texas Oncology Tyler Texas Recruiting
Intermountain Medical Center Murray Utah Recruiting
University of Virginia Health System Charlottesville Virginia Recruiting
Virginia Cancer Specialists, PC Gainesville Virginia Recruiting
Prince of Wales Hospital Randwick New South Wales Recruiting
Icon Cancer Centre Wesley Auchenflower Queensland Recruiting

+ 66 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06072781 on ClinicalTrials.gov ↗ ← All trials in Ireland