Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT06072781

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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