Ovarian Cancer Clinical Trial

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

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)

View Full Description

Full Description

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically proven LGSOC (ovarian, peritoneal)
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, if necessary

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

225

Study ID:

NCT04625270

Recruitment Status:

Recruiting

Sponsor:

Verastem, Inc.

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There are 46 Locations for this study

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Arizona Oncology Associates PC HAL
Scottsdale Arizona, 85258, United States More Info
Amela Ahmetovic
Contact
[email protected]
Mei Yu
Contact
[email protected]
Bradley J Monk, MD
Principal Investigator
Sansum Clinic
Santa Barbara California, 93105, United States More Info
Heidi Heitkamp
Contact
805-879-0643
[email protected]
Gregg Newman, MD
Principal Investigator
Yale School of Medicine
New Haven Connecticut, 06510, United States More Info
Lisa Baker
Contact
[email protected]
Alessandro Santin, MD
Principal Investigator
Advent Health
Orlando Florida, 32804, United States More Info
Alejandra Ricaute
Contact
[email protected]
Robert Holloway, MD
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute - Center for Women's Oncology
Tampa Florida, 33612, United States More Info
LaToya Hyde
Contact
[email protected]
Hye Sook Chon, MD
Principal Investigator
University of Chicago
Chicago Illinois, 60637, United States More Info
Hatti Koning
Contact
[email protected]
John Maroney, MD
Principal Investigator
Maryland Oncology and Hematology, P.A.
Glenn Dale Maryland, 20769, United States More Info
Corilynn Hughes
Contact
[email protected]
Carol Tweed, MD
Principal Investigator
Minnesota Oncology Hematology PA
Minneapolis Minnesota, 55404, United States More Info
Nykole Starks
Contact
[email protected]
Lauren Bollinger, MD
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Stephanie Russell
Contact
[email protected]
Premal Thaker, MD
Principal Investigator
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89128, United States More Info
Ann Lovelace
Contact
[email protected]
Anu Thummala, MD
Principal Investigator
University of New Mexico Comprehensive Cancer Center
Albuquerque New Mexico, 87131, United States More Info
Leslie Byatt
Contact
[email protected]
Carolyn Muller, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Rachel Grisham
Contact
646-888-4653
Rachel Grisham, MD
Principal Investigator
Cleveland Clinic Women's Health Institute
Cleveland Ohio, 44195, United States More Info
Donna White
Contact
[email protected]
Peter Rose, MD
Principal Investigator
The Ohio State University Wexner Medical Center
Columbus Ohio, 43212, United States More Info
Erika Prizzi
Contact
[email protected]
David O'Malley, MD
Principal Investigator
University of Oklahoma Medical Center
Oklahoma City Oklahoma, 73104, United States More Info
Erika Dobbs
Contact
[email protected]
Kathleen Moore, MD
Principal Investigator
Willamette Valley Cancer Institute and Research Center
Eugene Oregon, 97401, United States More Info
Nichole Fisher
Contact
[email protected]
Jeanne Schaffer
Contact
[email protected]
Charles Anderson, MD
Principal Investigator
Northwest Cancer Specialists
Portland Oregon, 97227, United States More Info
Julian Kern
Contact
[email protected]
Erin Salinas, MD
Principal Investigator
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Kristy Long
Contact
[email protected]
Erika Hamilton, MD
Principal Investigator
Texas Oncology Austin Central
Austin Texas, 78731, United States More Info
Michelle Owens
Contact
[email protected]
Lynne Knowles, MD
Principal Investigator
Texas Oncology- Dallas Presbyterian Hospital
Dallas Texas, 75231, United States More Info
Morgan Heim
Contact
[email protected]
Nancy Jones
Contact
[email protected]
Kristi McIntyre, MD
Principal Investigator
UT Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Tiffany Thomas
Contact
[email protected]
David Miller, MD
Principal Investigator
Texas Oncology
Longview Texas, 75601, United States More Info
Shelly Maxfield
Contact
[email protected]
Anna M Priebe, MD
Principal Investigator
Texas Oncology
McAllen Texas, 78503, United States More Info
Nereida Salinas
Contact
[email protected]
Suresh Ratnam, MD
Principal Investigator
Texas Oncology
San Antonio Texas, 78240, United States More Info
Alice Bock
Contact
[email protected]
Debora Lind
Contact
[email protected]
Antonio Santillian-Gomez, MD
Principal Investigator
Texas Oncology
The Woodlands Texas, 77380, United States More Info
Christina Genthon
Contact
[email protected]
Sandra Thornton
Contact
[email protected]
Christine Lee, MD
Principal Investigator
University of Virginia Health System
Charlottesville Virginia, 22908, United States More Info
Rachel Lacy
Contact
[email protected]
Chrystal Axford
Contact
[email protected]
Kari Ring, MD
Principal Investigator
Virginia Cancer Specialists, PC
Gainesville Virginia, 20155, United States More Info
Monica Cochrane
Contact
[email protected]
Marcy Sullivan
Contact
[email protected]
Mitul Gandhi, MD
Principal Investigator
Alex Spira, MD
Sub-Investigator
UZ Gent Medische Oncologie
Gent , 9000, Belgium More Info
Els Stommeleier
Contact
[email protected]
Hannelore Denys, MD
Principal Investigator
UZ Leuven
Leuven , 3000, Belgium More Info
Toon Van Gorp
Contact
[email protected]
Toon Van Gorp, MD
Principal Investigator
CHU de Liege
Liège , 4000, Belgium More Info
Chloe Denis
Contact
[email protected]
Christine Gennigens, MD
Principal Investigator
Centre de recherche di Centre Hospitalier de i'Universite de Montreal
Montréal , H2X 0, Canada More Info
Diane Provencher
Contact
[email protected]
Diane Provencher, MD
Principal Investigator
Princess Margaret Cancer Centre
Toronto , M5G2M, Canada More Info
Amit Oza
Contact
[email protected]
Amit Oza, MD
Principal Investigator
Hopital Jean Minjoz
Besançon , 2500, France More Info
Clovis Boibessot
Contact
[email protected]
Elsa Kalbacher, MD
Principal Investigator
Centre Leon Berard
Lyon , 69008, France More Info
Ibtissame Djedoui
Contact
[email protected]
Isabelle Ray-Coquard, MD
Principal Investigator
ICM - Val d'Aurelle
Montpellier , 34298, France More Info
Michel Fabbro, MD
Principal Investigator
Institut Curie
Paris , 75248, France More Info
Audrey Faye
Contact
[email protected]
Manuel Rodrigues, MD
Principal Investigator
Insituto Europeo di Oncologia I.R.C.C.S
Milano , 20141, Italy More Info
Nicoletta Colombo
Contact
[email protected]
Nicoletta Colombo, MD
Principal Investigator
U.O.C. Oncologia 2, Istituto Oncologico Veneto I.R.C.C.S.
Padova , 35128, Italy More Info
Valentina Guarneri
Contact
[email protected]
Valentina Guarneri, MD
Principal Investigator
Hospital Universitario Vall D'Hebron
Barcelona , 08035, Spain More Info
Alba Meire
Contact
[email protected]
Ana Oaknin, MD
Principal Investigator
Hospital Universitario Reina Sofia
Córdoba , 14004, Spain More Info
Maria Jesus Rubio
Contact
[email protected]
Maria Jesus Rubio, MD
Principal Investigator
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain More Info
Alfonso Cortes-Salgado
Contact
[email protected]
Alfonso Cortes -Salgado, MD
Principal Investigator
Hospital Clínico Universitario de Valencia
Valencia , 46010, Spain More Info
Jose Alejandro Perez Fidalgo
Contact
Jose Alejandro Perez Fidalgo, MD
Principal Investigator
Western General Hospital
Edinburgh , EH4 2, United Kingdom More Info
Ryan Simpson
Contact
0131 537 1234
[email protected]
Charlie Gourley, MD
Principal Investigator
Beatson West of Scotland Cancer Centre
Glasgow , G120Y, United Kingdom More Info
Shannon Fairley
Contact
[email protected]
Rosalind Glasspool, MD
Principal Investigator
UCLH Cancer Clinical Trials Unit
London , NW1 2, United Kingdom More Info
Melissa Hawkes-Blackburn
Contact
07790 895740
[email protected]
Rowan Miller, MD
Principal Investigator
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom More Info
Andrew Clamp
Contact
[email protected]
Andrew Clamp, MD
Principal Investigator
Royal Marsden Hospital
Sutton , , United Kingdom More Info
Kylie Fitch
Contact
Susana Banerjee, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

225

Study ID:

NCT04625270

Recruitment Status:

Recruiting

Sponsor:


Verastem, Inc.

How clear is this clinincal trial information?

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