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

Launched by VERASTEM, INC. · Oct 2, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for women with recurrent low-grade serous ovarian cancer (LGSOC), which means the cancer has come back after previous treatments. The study is testing a combination of two drugs, avutometinib (VS-6766) and defactinib (VS-6063), to see if they are safe and effective compared to other standard treatments chosen by the doctor. To join the study, participants need to have a confirmed diagnosis of LGSOC, have experienced cancer progression after at least one previous treatment, and meet certain health criteria.

Women between the ages of 65 and 74 may be eligible if they have specific genetic markers and have not had certain treatments in the past. Participants will receive the new combination therapy or the doctor’s choice of treatment and will be closely monitored throughout the study. It's important for potential participants to know that they will need to attend regular appointments for treatment and check-ups. This trial aims to find better options for women facing this challenging condition, and participating could help advance research in ovarian cancer treatment.

Gender

FEMALE

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.