A Study of VS-6766 v. VS-6766 + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation

  • Interventional
  • Recruiting
  • NCT04625270
Eligibility Details Visit Clinicaltrials.gov

A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) Alone and In Combination With Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

This study will assess the safety and efficacy of VS-6766 monotherapy and in combination with Defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

This is a multicenter, randomized, open-label Phase 2 study designed to evaluate safety and tolerability and preliminary efficacy of VS-6766 versus VS-6766 in combination with defactinib in subjects with molecularly profiled recurrent LGSOC.

Gender
Female

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Histologically proven LGSOC (ovarian, peritoneal)

         - In Part A KRAS mutation, KRAS wt

         - Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.

         - Measurable disease according to RECIST 1.1

         - An Eastern Cooperative Group (ECOG) performance status ≤ 1.

         - Adequate organ function

         - Adequate recovery from toxicities related to prior treatments

         - Agreement to use highly effective method of contraceptive

        Exclusion Criteria:

         - Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy

         - Co-existing high-grade ovarian cancer or another histology

         - History of prior malignancy with recurrence <3 years from the time of enrollment

         - Major surgery within 4 weeks

         - Symptomatic brain metastases requiring steroids or other interventions

         - Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy

         - For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor

         - Active skin disorder that has required systemic therapy within the past year

         - History of rhabdomyolysis

         - Concurrent ocular disorders

         - Concurrent heart disease or severe obstructive pulmonary disease

         - Subjects with the inability to swallow oral medications

At a Glance

National Government IDNCT04625270

IRB#IRB21-0072

Lead SponsorVerastem, Inc.

Lead PhysicianJohn Moroney

Collaborator(s)N/A

EligibilityFemale
18 Years and up
Recruiting