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RAMP-201: A Study of VS-6766 v. VS-6766 + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation

Sponsor
Verastem, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04625270
Collaborator
European Network of Gynaecological Oncological Trial Groups (ENGOT) (Other), GOG Foundation (Other)
100
Enrollment
45
Locations
2
Arms
59.3
Anticipated Duration (Months)
2.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Dec 21, 2020
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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)

Drug: VS-6766
VS-6766 Monotherapy

Drug: VS-6766 and Defactinib
VS-6766 and Defactinib Combination
Other Names:
  • VS-6766 and VS-6063

    		•
    Experimental: Part B

    To determine the efficacy of the optimal regimen identified from Part A

    Drug: VS-6766
    VS-6766 Monotherapy

    Drug: VS-6766 and Defactinib
    VS-6766 and Defactinib Combination
    Other Names:
  • VS-6766 and VS-6063

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Part A: Determine optimal regimen of VS-6766 monotherapy or in combination with defactinib [From start of treatment to confirmation of response; 24 weeks]

      Confirmed overall response rate per RECIST 1.1

    2. Part B: To determine the efficacy of the optimal regimen identified from Part A [From start of treatment to confirmation of response; 24 weeks]

      Confirmed overall response rate per RECIST 1.1

    Secondary Outcome Measures

    1. Overall Response Rate as assessed by Investigator [From start of treatment to confirmation of response; 24 weeks]

      Proportioned subjects achieving a CR or PR as assess by the investigator

    2. Duration of Response (DOR) [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]

      From time of first response to PD as assessed by the BIRC

    3. Disease Control Rate (DCR) [Greater than or equal to 8 weeks]

      CR+PR+stable disease

    4. Progression Free Survival (PFS) [Up to 5 years]

      From time of first dose of study intervention to PD or death for any cause

    5. Overall Survival (OS) [Up to 5 years]

      From time of first dose of study intervention to death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Oncology Associates PC HAL Scottsdale Arizona United States 85258
    2 Sansum Clinic Santa Barbara California United States 93105
    3 Yale School of Medicine New Haven Connecticut United States 06510
    4 Advent Health Orlando Florida United States 32804
    5 H. Lee Moffitt Cancer Center and Research Institute - Center for Women's Oncology Tampa Florida United States 33612
    6 University of Chicago Chicago Illinois United States 60637
    7 Maryland Oncology and Hematology, P.A. Glenn Dale Maryland United States 20769
    8 Minnesota Oncology Hematology PA Minneapolis Minnesota United States 55404
    9 Washington University School of Medicine Saint Louis Missouri United States 63110
    10 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89128
    11 University of New Mexico Comprehensive Cancer Center Albuquerque New Mexico United States 87131
    12 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    13 Cleveland Clinic Women's Health Institute Cleveland Ohio United States 44195
    14 The Ohio State University Wexner Medical Center Columbus Ohio United States 43212
    15 University of Oklahoma Medical Center Oklahoma City Oklahoma United States 73104
    16 Willamette Valley Cancer Institute and Research Center Eugene Oregon United States 97401
    17 Northwest Cancer Specialists Portland Oregon United States 97227
    18 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    19 Texas Oncology Austin Central Austin Texas United States 78731
    20 UT Southwestern Medical Center Dallas Texas United States 75390
    21 Texas Oncology Longview Texas United States 75601
    22 Texas Oncology McAllen Texas United States 78503
    23 Texas Oncology San Antonio Texas United States 78240
    24 Texas Oncology The Woodlands Texas United States 77380
    25 University of Virginia Health System Charlottesville Virginia United States 22908
    26 Virginia Cancer Specialists Fairfax Virginia United States 22031
    27 Virginia Cancer Specialists, PC Gainesville Virginia United States 20155
    28 UZ Gent Medische Oncologie Gent Belgium 9000
    29 UZ Leuven Leuven Belgium 3000
    30 CHU de Liege Liège Belgium 4000
    31 Centre de recherche di Centre Hospitalier de i'Universite de Montreal Montréal Canada H2X 0A9
    32 Princess Margaret Cancer Centre Toronto Canada M5G2M9
    33 Hopital Jean Minjoz Besançon France 2500
    34 Centre Leon Berard Lyon France 69008
    35 ICM - Val d'Aurelle Montpellier France 34298
    36 Institut Curie Paris France 75248
    37 Insituto Europeo di Oncologia I.R.C.C.S Milano Italy 20141
    38 Hospital Universitario Vall D'Hebron Barcelona Spain 08035
    39 Hospital Universitario Reina Sofia Córdoba Spain 14004
    40 Hospital Universitario Ramon y Cajal Madrid Spain 28034
    41 Western General Hospital Edinburgh United Kingdom EH4 2XU
    42 Beatson West of Scotland Cancer Centre Glasgow United Kingdom G120YN
    43 UCLH Cancer Clinical Trials Unit London United Kingdom NW1 2PG
    44 The Christie NHS Foundation Trust Manchester United Kingdom M20 4BX
    45 Royal Marsden Hospital Sutton United Kingdom

    Sponsors and Collaborators

    • Verastem, Inc.
    • European Network of Gynaecological Oncological Trial Groups (ENGOT)
    • GOG Foundation

    Investigators

    • Principal Investigator: Susana Banerjee, MBBS,MA,PhD, European Network of Gynaecological Oncological Trial Groups (ENGOT)
    • Principal Investigator: Rachel Grisham, MD, GOG Foundation
    • Study Director: Hagop Youssoufian, MSc, MD, Verastem, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Verastem, Inc.
    ClinicalTrials.gov Identifier:
    NCT04625270
    Other Study ID Numbers:
    • VS-6766-201
    • GOG-3052
    • ENGOT-ov60
    First Posted:
    Nov 12, 2020
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Verastem, Inc.
    Low Grade Serous Ovarian Cancer
    KRAS, KRAS wt
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    No Results Posted as of Jul 14, 2022