Open
Actively Recruiting
A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
About
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
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 Criteria:
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.
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
23-5248
Category
Ovarian Cancer
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood