RecruitingPhase 3NCT06072781
A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)
Sponsor
Verastem, Inc.
Enrollment
270 participants
Start Date
Mar 18, 2024
Study Type
INTERVENTIONAL
Conditions
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: FEMALEMin Age: 18 Years
Inclusion Criteria11
- 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 Criteria18
- 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.
Interventions
DRUGAnastrozole
administered orally
DRUGavutometinib
Avutometinib: administered orally
DRUGDefactinib
Defactinib: administered orally
DRUGPegylated liposomal doxorubicin
administered intravenously
DRUGPaclitaxel
administered intravenously
DRUGLetrozole
administered orally
Locations(106)
View Full Details on ClinicalTrials.gov
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NCT06072781
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