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Back|NCT06072781Recruiting
Official Title

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)

Phase
Phase 3
Sponsor
Verastem, Inc.
Enrollment
270
Timeline
Mar 2024 → Feb 2031
About This Study

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

  • 1Patients may be eligible for inclusion in the study if they meet the following criteria:
  • 2Histologically proven LGSOC (ovarian, fallopian, peritoneal)
  • 3Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test.
  • 4Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole.
  • 5Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
  • 6Measurable disease according to RECIST v1.1.
  • 7An Eastern Cooperative Group (ECOG) performance status ≤ 1.
  • 8Adequate organ function.
  • 9Adequate recovery from toxicities related to prior treatments.
  • 10For patients with reproductive potential, a negative pregnancy test must be confirmed and agreement to use highly effective method of contraceptive.
  • 11Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria

  • 1Patients will be excluded from the study if they meet any of the following criteria:
  • 2Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
  • 3Co-existing high-grade serous ovarian cancer or mixed histology.
  • 4Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
  • 5History of prior malignancy with recurrence \<3 years from the time of enrollment.
  • 6Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week of the first dose of study intervention.
  • 7Symptomatic brain metastases requiring steroids or other interventions, known leptomeningeal metastases, or spinal cord compression.
  • 8An active skin disorder that has required systemic therapy within one year of the first dose of study intervention.
  • 9History of medically significant rhabdomyolysis.
  • 10For subjects with prior MEK or RAF exposure, Grade 4 toxicity is deemed related to the MEK inhibitor.
  • 11Symptomatic bowel obstruction within 3 months of the first dose of study intervention
  • 12Concurrent ocular disorders.
  • 13Concurrent heart disease or severe obstructive pulmonary disease.
  • 14Active or past medical history of interstitial lung disease/pneumonitis, including drug-induced or radiation pneumonitis, pulmonary fibrosis, or adult respiratory distress syndrome (ARDS).
  • 15Subjects with the inability to swallow oral medications.
  • 16History 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.
  • 17Pregnant or breastfeeding.
  • 18Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.

Locations

105 sites participating in this study

Winship Cancer Institute at Emory University

Atlanta, Georgia 30322

Recruiting

Susan Modesitt, MD

HonorHealth

Phoenix, Arizona 85016

Recruiting

Lyndsay Willmott, MD

University of Arkansas

Little Rock, Arkansas 72205

Recruiting

Heather Williams, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →