Clinical Trials /

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

NCT04625270

Description:

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)

Related Conditions:
  • Low Grade Ovarian Serous Adenocarcinoma
  • Primary Peritoneal Low Grade Serous Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of VS-6766 v. VS-6766 + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation
  • Official 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)

Clinical Trial IDs

  • ORG STUDY ID: VS-6766-201
  • NCT ID: NCT04625270

Conditions

  • Ovarian Cancer

Interventions

DrugSynonymsArms
VS-6766Part A
VS-6766 and DefactinibVS-6766 and VS-6063Part A

Purpose

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)

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Part AExperimentalTo 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)
  • VS-6766
  • VS-6766 and Defactinib
Part BExperimentalTo determine the efficacy of the optimal regimen identified from Part A
  • VS-6766
  • VS-6766 and Defactinib

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically proven LGSOC (ovarian, peritoneal)

          -  In Part A KRAS mutation

          -  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 ≤28 days prior to first dose of study therapy

          -  For subjects with prior MEK exposure, Grade 3 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part A: Determine optimal regimen of VS-6766 monotherapy or in combination with defactinib
Time Frame:From start of treatment to confirmation of response; 24 weeks
Safety Issue:
Description:Confirmed overall response rate per RECIST 1.1

Secondary Outcome Measures

Measure:Overall Response Rate as assessed by Investigator
Time Frame:From start of treatment to confirmation of response; 24 weeks
Safety Issue:
Description:Proportioned subjects achieving a CR or PR as assess by the investigator
Measure:Duration of Response (DOR)
Time Frame:Time from the first documentation of response to first documentation of progressive disease or death due to any cause, greater than or equal to 6 months
Safety Issue:
Description:From time of first response to PD as assessed by the IRC
Measure:Disease Control Rate (DCR)
Time Frame:Greater than or equal to 8 weeks
Safety Issue:
Description:CR+PR+stable disease as assessed by the IRC
Measure:Progression Free Survival (PFS)
Time Frame:Up to 5 years
Safety Issue:
Description:From time of first dose of study intervention to PD or death for any cause
Measure:Overall Survival (OS)
Time Frame:Up to 5 years
Safety Issue:
Description:From time of first dose of study intervention to death

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Verastem, Inc.

Trial Keywords

  • Low Grade Serous Ovarian Cancer
  • KRAS

Last Updated

November 12, 2020