Actively Recruiting
A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
Led by Verastem, Inc. · Updated on 2026-04-02
270
Participants Needed
106
Research Sites
359 weeks
Total Duration
On this page
Sponsors
V
Verastem, Inc.
Lead Sponsor
G
GOG Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.
CONDITIONS
Official Title
A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed low-grade serous ovarian cancer (ovarian, fallopian, peritoneal)
- Documented KRAS mutation status by a validated tumor tissue test
- Eligible for at least one investigator's choice treatment: pegylated liposomal doxorubicin, paclitaxel, letrozole, or anastrozole
- Disease progression or recurrence after at least one prior systemic therapy for metastatic disease
- Measurable disease according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Fully recovered from toxicities of prior treatments
- Negative pregnancy test if of reproductive potential and agreement to use highly effective contraception
- Willingness to follow study visits, treatments, lab tests, and procedures
You will not qualify if you...
- Systemic anti-cancer therapy within 4 weeks before first study treatment dose
- Presence of high-grade serous ovarian cancer or mixed histology
- Prior treatment with avutometinib, defactinib, or other FAK inhibitors
- History of prior malignancy with recurrence within 3 years before enrollment
- Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week before first dose
- Symptomatic brain metastases requiring steroids or interventions, leptomeningeal metastases, or spinal cord compression
- Active skin disorder requiring systemic therapy within 1 year before first dose
- History of serious muscle breakdown (rhabdomyolysis)
- Grade 4 toxicity related to prior MEK inhibitor treatment
- Symptomatic bowel obstruction within 3 months before first dose
- Concurrent eye disorders
- Concurrent heart disease or severe obstructive lung disease
- Active or past interstitial lung disease or similar lung conditions
- Inability to swallow oral medications
- History of allergic reaction to any study drug ingredients or planned treatments
- Pregnant or breastfeeding
- Active uncontrolled infection requiring systemic therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 106 locations
1
HonorHealth
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
University of Arkansas
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
UCLA Health
Los Angeles, California, United States, 90095
Actively Recruiting
4
UC Davis
Sacramento, California, United States, 95817
Actively Recruiting
5
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
6
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
7
Florida Cancer Specialists - South
Fort Myers, Florida, United States, 33901
Actively Recruiting
8
Mount Sinai
Miami Beach, Florida, United States, 33140
Actively Recruiting
9
AdventHealth
Orlando, Florida, United States, 32804
Actively Recruiting
10
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
11
Florida Cancer Specialists Research East
West Palm Beach, Florida, United States, 33401
Actively Recruiting
12
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
13
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Actively Recruiting
14
Louisiana State University
New Orleans, Louisiana, United States, 70112
Actively Recruiting
15
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
16
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Actively Recruiting
17
Minnesota Oncology Hematology
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
18
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
19
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
20
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
21
Atrium Health
Charlotte, North Carolina, United States, 28203
Actively Recruiting
22
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
23
Ohio State
Hilliard, Ohio, United States, 43026
Actively Recruiting
24
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
25
Willamette Valley Cancer Institute
Eugene, Oregon, United States, 97401
Actively Recruiting
26
Northwest Cancer Specialists
Portland, Oregon, United States, 97227
Actively Recruiting
27
Asplundh Cancer Pavilion | Jefferson Health
Philadelphia, Pennsylvania, United States, 19090
Actively Recruiting
28
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
29
Texas Oncology Central
Austin, Texas, United States, 78731
Actively Recruiting
30
Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
31
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
32
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
33
Texas Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
34
Texas Oncology
The Woodlands, Texas, United States, 77380
Actively Recruiting
35
Texas Oncology
Tyler, Texas, United States, 75702
Actively Recruiting
36
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
37
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Actively Recruiting
38
Virginia Cancer Specialists, PC
Gainesville, Virginia, United States, 20155
Actively Recruiting
39
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
40
Icon Cancer Centre Wesley
Auchenflower, Queensland, Australia, 4066
Actively Recruiting
41
Cancer Research South Australia
Adelaide, South Australia, Australia, 5000
Actively Recruiting
42
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
43
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
44
UZA
Edegem, Belgium, 2650
Actively Recruiting
45
University Hospital Ghent
Ghent, Belgium, 9000
Actively Recruiting
46
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 1X6
Actively Recruiting
47
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
48
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
49
British of Columbia
Vancouver, Canada, V5Z 4E6
Actively Recruiting
50
Aalborg U.H
Aalborg, Denmark, 9000
Actively Recruiting
51
Centre Hospitalier de Besançon
Besançon, France, 25000
Actively Recruiting
52
Site Georges François Leclerc
Dijon, France, 21079
Actively Recruiting
53
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
54
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
55
Institut Curie
Paris, France
Actively Recruiting
56
Agaplesion Markus Krankenhaus
Frankfurt am Main, Hesse, Germany, 60431
Actively Recruiting
57
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
58
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Actively Recruiting
59
Kliniken Essen-Mitte
Essen, Germany, 45136
Actively Recruiting
60
UMC Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
61
Universitätsklinikum Mannheim GmbH
Mannheim, Germany, 68167
Actively Recruiting
62
Universitätsfrauenkinik Ulm
Ulm, Germany, 89075
Actively Recruiting
63
St. James's Hospital
Dublin, Ireland, 08
Actively Recruiting
64
Centro di Riferimento Oncologico (CRO)
Aviano, Italy, 33081
Actively Recruiting
65
Spedali Civili
Brescia, Italy, 25123
Actively Recruiting
66
AO Cannizzaro
Catania, Italy, 95126
Actively Recruiting
67
San Raffaele Hospital
Milan, Italy, 20132
Actively Recruiting
68
Humanitas San Pio X
Milan, Italy, 20159
Actively Recruiting
69
European Institute of Oncology (IEO)
Milan, Italy
Actively Recruiting
70
Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
71
INT Napoli Hospital
Naples, Italy
Actively Recruiting
72
Istituto Oncologico Veneto (IOV)
Padova, Italy, 35128
Actively Recruiting
73
IRCCS Gemelli
Roma, Italy, 00168
Actively Recruiting
74
Istituti Fisioterapici Ospitalieri
Rome, Italy, 00144
Actively Recruiting
75
S.C.D.U. Oncologia
Torino, Italy, 10128
Actively Recruiting
76
The Mie University Hospital
Tsu, Mie-ken, Japan, 514-8507
Actively Recruiting
77
Aichi Cancer Center Hospital
Aichi, Nagoya, Japan, 464-8681
Actively Recruiting
78
Tohoku University Hospital
Miyagi, Japan, 980-8574
Actively Recruiting
79
Osaka Medical Center
Osaka, Japan
Actively Recruiting
80
The Jikei University Hospital
Tokyo, Japan, 3-19-18
Actively Recruiting
81
Netherlands Cancer Insitute
Amsterdam, Netherlands, 1066
Actively Recruiting
82
Radboud UMC
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
83
Auckland City Hospital
Auckland, New Zealand, 1023
Actively Recruiting
84
Białostockie Centrum Onkologii
Bialystok, Poland, 15-027
Actively Recruiting
85
Gdański Uniwersytet Medyczny
Gdansk, Poland, 80-214
Actively Recruiting
86
Siedleckie Centrum Onkologii
Siedlce, Poland, 98-110
Actively Recruiting
87
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Actively Recruiting
88
Yonsei University Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
89
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
90
Gangnam Severance Hospital
Seoul, South Korea, 06273
Actively Recruiting
91
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
92
Clínico Virgen de La Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
93
H. de Donostia
Donostia / San Sebastian, San Sebastian, Spain, 20014
Actively Recruiting
94
H. Vall d´ Hebron
Barcelona, Spain
Actively Recruiting
95
Hospital Universitario Reina Sofía
Córdoba, Spain
Actively Recruiting
96
H.U. Ramón y Cajal
Madrid, Spain
Actively Recruiting
97
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Spain, 15706
Actively Recruiting
98
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
99
Greater Glasgow and Clyde (GGC)
Glasgow, Scotland, United Kingdom, G120YN
Actively Recruiting
100
Cambridge University Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
101
University of Edinburgh Cancer Research Centre
Edinburgh, United Kingdom
Actively Recruiting
102
Hope Cancer Trials Centre
Leicester, United Kingdom, LE2 7LX
Actively Recruiting
103
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Actively Recruiting
104
Royal Marsden Hospital
London, United Kingdom, SW7 3RP
Actively Recruiting
105
The Christie NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
106
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
V
Verastem Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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