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Clinical Trial 21119

Cancer Type: Gynecological Tumor
Study Type: Treatment
NCT#: NCT04625270

Phase: Phase II
Prinicipal Investigator: Hye Sook Chon

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Overview

Study Title

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)

Summary

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)

Objective

Primary Objectives (Parts A and B) Part A: To determine the optimal regimen, either VS-6766 monotherapy or VS-6766 in combination with defactinib, for subsequent evaluation for efficacy in the expansion phase (Part B). Part B: To determine the efficacy of the optimal regimen identified from Part A. Secondary Objectives (Parts A and B) To characterize the safety and toxicity profile of VS-6766 as a monotherapy and in combination with defactinib in LGSOC. Part A: To evaluate additional efficacy parameters for VS-6766 monotherapy and in combination with defactinib. Part B: To evaluate additional efficacy parameters for the optimal regimen identified in Part A. To characterize the pharmacokinetics (PK) of VS-6766, defactinib, and relevant metabolites.

Treatments

Therapies

Medications

Defactinib (VS-6063); VS-6766 ()

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 > 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 > Major surgery within 4 weeks
  • Symptomatic brain metastases requiring steroids or other interventions
  • Known SARS-Cov2 infection (clinical symptoms) > 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

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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