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)
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
- SECONDARY ID:
GOG-3052
- SECONDARY ID:
ENGOT-ov60
- NCT ID:
NCT04625270
Conditions
Interventions
Drug | Synonyms | Arms |
---|
VS-6766 | | Part A |
VS-6766 and Defactinib | VS-6766 and VS-6063 | Part 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
Name | Type | Description | Interventions |
---|
Part A | Experimental | 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) | - VS-6766
- VS-6766 and Defactinib
|
Part B | Experimental | To 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, 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
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 BIRC |
Measure: | Disease Control Rate (DCR) |
Time Frame: | Greater than or equal to 8 weeks |
Safety Issue: | |
Description: | CR+PR+stable disease |
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: | Recruiting |
Lead Sponsor: | Verastem, Inc. |
Trial Keywords
- Low Grade Serous Ovarian Cancer
- KRAS, KRAS wt
Last Updated
August 25, 2021