A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer (RAMP 301)

April 1, 2026 updated by: Verastem, Inc.

A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This international, randomized, open-label, Phase 3 study will compare the investigational combination of avutometinib plus defactinib versus Investigator's Choice of Treatments (ICT) in patients with recurrent LGSOC who have progressed on a prior platinum-based therapy. Avutometinib and defactinib are both types of drugs called kinase inhibitors. Kinase inhibitors block cancer cell growth. The study will compare the progression-free survival (PFS) of the combination of avutometinib plus defactinib versus ICT. The study will also evaluate the effect of the combination on safety, overall survival, other efficacy endpoints, and health-related quality of life and disease related symptoms. The study is being conducted by gynecological cancer specialists. Patients who are eligible and agree to participate in this study will be treated with either a combination of avutometinib with defactinib, or with one of four standard of care NCCN and ESMO treatment recommendations for recurrent LGSOC, and then with subsequent follow up appointments. Patients who originally received one of the standards of care treatments who are determined to have progressive disease may be eligible to crossover to receive the investigational combination avutometinib plus defactinib.Avutometinib and defactinib are investigational drugs that have not been approved by the U.S. Food and Drug Administration (FDA)

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Recruiting
        • Icon Cancer Centre Wesley
        • Contact:
        • Principal Investigator:
          • Jeffrey Goh, MD
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Cancer Research South Australia
        • Contact:
        • Principal Investigator:
          • Meena Okera, MD
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
        • Principal Investigator:
          • Sumitra Ananda, MD
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • Belgium
      • Edegem, Belgium, 2650
        • Recruiting
        • UZA
        • Contact:
        • Principal Investigator:
          • Konstantinos Papadimitriou, MD
      • Ghent, Belgium, 9000
        • Recruiting
        • University Hospital Ghent
        • Principal Investigator:
          • Hannelore Denys, MD
        • Contact:
  • Canada
      • Vancouver, Canada, V5Z 4E6
        • Recruiting
        • British of Columbia
        • Principal Investigator:
          • Anna Tinker, MD
        • Contact:
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X6
        • Recruiting
        • Princess Margaret Cancer Center
        • Principal Investigator:
          • Amit Oza, MD
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre
        • Principal Investigator:
          • Lucy Gilbert, MD
        • Contact:
      • Montreal, Quebec, Canada, H2X 0C1
  • Denmark
      • Aalborg, Denmark, 9000
        • Recruiting
        • Aalborg U.H
        • Contact:
          • Mette Raaschou
          • Phone Number: 4597661291
          • Email: mera@rn.dk
        • Principal Investigator:
          • Charlotte A Haslund, MD
  • France
      • Besançon, France, 25000
        • Recruiting
        • Centre Hospitalier de Besançon
        • Principal Investigator:
          • Laura Mansi, MD
        • Contact:
      • Dijon, France, 21079
        • Recruiting
        • Site Georges François Leclerc
        • Contact:
        • Principal Investigator:
          • Jean-David FUMET, MD
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
        • Principal Investigator:
          • Cyril Abdeddaim, MD
      • Lyon, France, 69373
      • Paris, France
  • Germany
      • Berlin, Germany, 13353
      • Dresden, Germany, 01307
      • Essen, Germany, 45136
        • Recruiting
        • Kliniken Essen-Mitte
        • Contact:
        • Principal Investigator:
          • Philipp Harter, MD
      • Hamburg, Germany, 20246
        • Recruiting
        • UMC Hamburg-Eppendorf
        • Contact:
        • Principal Investigator:
          • Barbara Schmalfeldt, MD
      • Mannheim, Germany, 68167
        • Recruiting
        • Universitätsklinikum Mannheim GmbH
        • Principal Investigator:
          • Frederik Marmé, MD
        • Contact:
      • Ulm, Germany, 89075
        • Recruiting
        • Universitätsfrauenkinik Ulm
        • Contact:
        • Principal Investigator:
          • Fabienne Schochter, MD
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60431
        • Recruiting
        • Agaplesion Markus Krankenhaus
        • Contact:
        • Principal Investigator:
          • Marc Thill, MD
  • Ireland
      • Dublin, Ireland, 08
        • Recruiting
        • St. James's Hospital
        • Contact:
        • Principal Investigator:
          • Karen Cadoo, MD
  • Italy
      • Aviano, Italy, 33081
        • Recruiting
        • Centro di Riferimento Oncologico (CRO)
        • Principal Investigator:
          • Michelle Bartoletti, MD
        • Contact:
      • Brescia, Italy, 25123
        • Recruiting
        • Spedali Civili
        • Principal Investigator:
          • Germana Tognon, MD
        • Contact:
      • Catania, Italy, 95126
      • Milan, Italy, 20132
        • Recruiting
        • San Raffaele Hospital
        • Contact:
        • Principal Investigator:
          • Giorgia Mangili, MD
      • Milan, Italy, 20133
      • Milan, Italy
        • Recruiting
        • European Institute of Oncology (IEO)
        • Principal Investigator:
          • Nicoletta Columbo, MD
        • Contact:
      • Milan, Italy, 20159
      • Naples, Italy
      • Padova, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto (IOV)
        • Principal Investigator:
          • Valentina Guarneri, MD
        • Contact:
      • Roma, Italy, 00168
      • Rome, Italy, 00144
        • Recruiting
        • Istituti Fisioterapici Ospitalieri
        • Contact:
        • Principal Investigator:
          • Savarese Antonella, MD
      • Torino, Italy, 10128
        • Recruiting
        • S.C.D.U. Oncologia
        • Contact:
        • Principal Investigator:
          • Giorgio Valabrega, MD
  • Japan
      • Miyagi, Japan, 980-8574
      • Osaka, Japan
        • Recruiting
        • Osaka Medical Center
        • Principal Investigator:
          • Satoe Fujiwara, MD
        • Contact:
      • Tokyo, Japan, 3-19-18
        • Recruiting
        • The Jikei University Hospital
        • Contact:
        • Principal Investigator:
          • Nozomu Yanaihara, MD
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
    • Nagoya
      • Aichi, Nagoya, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center Hospital
        • Contact:
        • Principal Investigator:
          • Shiro Suzuki, MD
  • Netherlands
      • Amsterdam, Netherlands, 1066
        • Recruiting
        • Netherlands Cancer Insitute
        • Contact:
        • Principal Investigator:
          • Frans Opdam
      • Nijmegen, Netherlands, 6525 GA
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital
        • Principal Investigator:
          • Michelle Wilson, MD
        • Contact:
  • Poland
      • Bialystok, Poland, 15-027
        • Recruiting
        • Białostockie Centrum Onkologii
        • Principal Investigator:
          • Beata Maćkowiak-Matejczyk, MD
        • Contact:
      • Gdansk, Poland, 80-214
        • Recruiting
        • Gdański Uniwersytet Medyczny
        • Contact:
        • Principal Investigator:
          • Dagmara Klasa-Mazurkiewicz, MD
      • Siedlce, Poland, 98-110
  • South Korea
      • Seongnam, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Kidong Kim, MD
        • Contact:
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Shin Wah Lee, MD
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Chel Hun Choi, MD
        • Contact:
        • Contact:
      • Seoul, South Korea, 06273
        • Recruiting
        • Gangnam Severance Hospital
        • Principal Investigator:
          • Jae-Hoon Kim, MD
        • Contact:
        • Contact:
      • Seoul, South Korea, 03722
        • Recruiting
        • Yonsei University Severance Hospital
        • Principal Investigator:
          • Sang Wun Kim, MD
        • Contact:
          • Sang Wun Kim
          • Phone Number: 010-7209-8433; 02-2228-2230
          • Email: san1@yuhs.ac
  • Spain
      • Barcelona, Spain
        • Recruiting
        • H. Vall d´ Hebron
        • Principal Investigator:
          • Ana Oaknin, MD
        • Contact:
      • Córdoba, Spain
        • Recruiting
        • Hospital Universitario Reina Sofía
        • Principal Investigator:
          • Maria Jesus Rubio, MD
        • Contact:
      • Madrid, Spain
        • Recruiting
        • H.U. Ramón y Cajal
        • Principal Investigator:
          • Alfonso Cortes Salgado, MD
        • Contact:
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Hospital Clínico Universitario de Santiago
        • Principal Investigator:
          • Juan Cueva Bañuelos, MD
        • Contact:
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
        • Principal Investigator:
          • Alejandro Perez Fidalgo, MD
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Clínico Virgen de La Arrixaca
        • Contact:
        • Principal Investigator:
          • Ana Puertes Boix, MD
    • San Sebastian
      • Donostia / San Sebastian, San Sebastian, Spain, 20014
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Cambridge University Hospital
        • Contact:
        • Principal Investigator:
          • Joo Ern Ang, MD
      • Edinburgh, United Kingdom
        • Recruiting
        • University of Edinburgh Cancer Research Centre
        • Principal Investigator:
          • Charlie Gourley, MD
        • Contact:
      • Leicester, United Kingdom, LE2 7LX
        • Recruiting
        • Hope Cancer Trials Centre
        • Contact:
        • Principal Investigator:
          • Joey Wood, MD
      • London, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospitals Nhs Foundation Trust
        • Principal Investigator:
          • Rowan Miller, MD
        • Contact:
        • Contact:
      • London, United Kingdom, SW7 3RP
        • Recruiting
        • Royal Marsden Hospital
        • Principal Investigator:
          • Susana Banerjee, MD
        • Contact:
      • Manchester, United Kingdom
        • Recruiting
        • The Christie NHS Foundation Trust
        • Principal Investigator:
          • Andrew Clamp, MD
        • Contact:
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital
        • Principal Investigator:
          • Susana Banerjee, MD
        • Contact:
    • Scotland
      • Glasgow, Scotland, United Kingdom, G120YN
        • Recruiting
        • Greater Glasgow and Clyde (GGC)
        • Principal Investigator:
          • Ros Glasspool, MD
        • Contact:
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Honorhealth
        • Principal Investigator:
          • Lyndsay Willmott, MD
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas
        • Principal Investigator:
          • Heather Williams, MD
        • Contact:
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Health
        • Principal Investigator:
          • Ritu Salani, MD
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis
        • Principal Investigator:
          • Hui Amy Chen, MD
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Principal Investigator:
          • Jocelyn Chapman, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Alessandro Santin, MD
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialists - South
        • Principal Investigator:
          • Elizabeth Guancial, MD
        • Contact:
      • Miami Beach, Florida, United States, 33140
      • Orlando, Florida, United States, 32804
      • Tampa, Florida, United States, 33612
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Florida Cancer Specialists Research East
        • Principal Investigator:
          • Bradley Monk, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute at Emory University
        • Principal Investigator:
          • Susan Modesitt, MD
        • Contact:
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • NorthShore University Healthsystem
        • Principal Investigator:
          • Mary Tilley Jenkins-Vogel, MD
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Louisiana State University
        • Principal Investigator:
          • Amelia Jernigan, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
        • Principal Investigator:
          • Stephanie Gaillard, MD
        • Contact:
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Center
        • Principal Investigator:
          • Robert Morris, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Premal Thaker, MD
        • Contact:
    • New York
      • Buffalo, New York, United States, 14263
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Rachel Grisham
          • Phone Number: 646-888-4653
        • Principal Investigator:
          • Rachel Grisham, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Principal Investigator:
          • Peter Rose, MD
        • Contact:
      • Hilliard, Ohio, United States, 43026
        • Recruiting
        • Ohio State
        • Contact:
        • Principal Investigator:
          • Christa Nagel, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Medical Center
        • Principal Investigator:
          • Christina Washington, MD
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Willamette Valley Cancer Institute
        • Principal Investigator:
          • Charles Anderson, MD
        • Contact:
      • Portland, Oregon, United States, 97227
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19090
        • Recruiting
        • Asplundh Cancer Pavilion | Jefferson Health
        • Principal Investigator:
          • Mitchell Edelson, MD
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Allegheny Health Network
        • Principal Investigator:
          • Thomas Krivak, MD
        • Contact:
    • Texas
      • Austin, Texas, United States, 78731
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Texas Oncology-Fort Worth Cancer Center
        • Contact:
        • Principal Investigator:
          • Noelle Cloven, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Lauren Cobb, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist
        • Principal Investigator:
          • Aparna Kamat, MD
        • Contact:
      • San Antonio, Texas, United States, 78229
      • The Woodlands, Texas, United States, 77380
      • Tyler, Texas, United States, 75702
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Contact:
        • Principal Investigator:
          • Ying Ning, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Health System
        • Principal Investigator:
          • Kari Ring, MD
        • Contact:
      • Gainesville, Virginia, United States, 20155

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients may be eligible for inclusion in the study if they meet the following criteria:

  1. Histologically proven LGSOC (ovarian, fallopian, peritoneal)
  2. Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test.
  3. Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole.
  4. Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
  5. Measurable disease according to RECIST v1.1.
  6. An Eastern Cooperative Group (ECOG) performance status ≤ 1.
  7. Adequate organ function.
  8. Adequate recovery from toxicities related to prior treatments.
  9. For patients with reproductive potential, a negative pregnancy test must be confirmed and agreement to use highly effective method of contraceptive.
  10. Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

  1. Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
  2. Co-existing high-grade serous ovarian cancer or mixed histology.
  3. Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
  4. History of prior malignancy with recurrence <3 years from the time of enrollment.
  5. Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week of the first dose of study intervention.
  6. Symptomatic brain metastases requiring steroids or other interventions, known leptomeningeal metastases, or spinal cord compression.
  7. An active skin disorder that has required systemic therapy within one year of the first dose of study intervention.
  8. History of medically significant rhabdomyolysis.
  9. For subjects with prior MEK or RAF exposure, Grade 4 toxicity is deemed related to the MEK inhibitor.
  10. Symptomatic bowel obstruction within 3 months of the first dose of study intervention
  11. Concurrent ocular disorders.
  12. Concurrent heart disease or severe obstructive pulmonary disease.
  13. Active or past medical history of interstitial lung disease/pneumonitis, including drug-induced or radiation pneumonitis, pulmonary fibrosis, or adult respiratory distress syndrome (ARDS).
  14. Subjects with the inability to swallow oral medications.
  15. History of hypersensitivity to any of the active agents or ingredients of study intervention: peanut, soya, polyoxyl castor oil, etcetc.). Prior hypersensitivity to anthracyclines or anthracenediones if the use of pegylated liposomal doxorubicin (PLD) is planned.
  16. Pregnant or breastfeeding.
  17. Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: avutometinib + defactinib
Avutometinib 3.2 mg, PO, twice weekly for 21 days on, 7 days off in a 28-day (4 weeks) cycle in combination with defactinib 200 mg, PO, twice daily for 21 days on, 7 days off in a 28-day(4 week) cycle.
Drug: avutometinib
Avutometinib: administered orally
Other Names:
  • avutometinib (VS-6766)
Drug: Defactinib
Defactinib: administered orally
Other Names:
  • defactinib (VS-6063)
Active Comparator: Investigator Choice of Treatment (ICT)

Patients will receive one of the following therapies as determined by the Investigator:

  • Pegylated liposomal doxorubicin: 40 mg/m2 IV on Day 1 of each 28-day (4 week) cycle.
  • Paclitaxel: 80 mg/m2 IV on Days 1, 8, and 15 of each 28-day (4 week) cycle.
  • Anastrozole: 1 mg, PO, once daily of each 28-day (4 week) cycle.
  • Letrozole: 2.5 mg, PO, once daily of each 28-day (4 week) cycle.
Drug: Paclitaxel
administered intravenously
Other Names:
  • Nov-Onxol, Onxol, Navaplus, Taxol
Drug: Pegylated liposomal doxorubicin
administered intravenously
Other Names:
  • Caelyx, Doxil, Lipodox
Drug: Letrozole
administered orally
Other Names:
  • Femara
Drug: Anastrozole
administered orally
Other Names:
  • Arimidex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) per blinded independent central review (BICR)
Time Frame: Up to 24 months
Progression-free survival (PFS) according to RECIST version 1.1, per blinded independent central review (BICR)
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 5 years
From the time of first dose of study intervention to PD as assessed per RECIST 1.1 or death from any cause
Up to 5 years
Objective response rate (ORR)
Time Frame: 12 months
From the time of first dose of study intervention to PD as assessed per RECIST 1.1 by Investigator or death from any cause
12 months
Duration of Response (DOR)
Time Frame: 12 months
From the time of first dose of study intervention to PD as assessed per RECIST 1.1 by Investigator or death from any cause
12 months
Disease Control Rate (DCR)
Time Frame: 6 months
CR+PR+Stable disease
6 months
Frequency and severity adverse events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 25 months
Count of AE and SAEs by grade, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading scale
25 months
Area under the plasma concentration-time curve (AUC) of avutometinib, defactinib and relative metabolites
Time Frame: 5 months
Area under plasma Concentration (AUC) 0 to t
5 months
Maximum plasma concentration (Cmax) of avutometinib, defactinib and relative metabolites
Time Frame: 5 months
maximum plasma concentration
5 months
To assess the health-related quality of life and disease based on European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire Core module C30 (QLQ-C30).
Time Frame: 24 months
The EORTC QLQ-C30 is a validated questionnaire to assess the quality of life of ovarian cancer patients.
24 months
To assess the health-related quality of life and disease based on European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire Ovarian Cancer module OV28 (QLQ-OV28).
Time Frame: 24 months
The EORTC QLQ-OV28 is a validated questionnaire to assess the quality of life of ovarian cancer patients.
24 months
To assess the health-related quality of life and disease based on EuroQol-5 Dimension 5-level (EQ-5D-5L)
Time Frame: 24 months
The EuroQol-5 Dimension 5-level (EQ-5D-5L) is a validated questionnaire used to measure a patient's overall health.
24 months
Progression Free Survival (PFS) per investigator assessment
Time Frame: 24 months
Progression-free survival (PFS) according to RECIST version 1.1, per blinded independent central review (BICR)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Verastem, Inc.

Collaborators

GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Korean Gynecologic Oncology Group
Australia New Zealand Gynaecological Oncology Group

Investigators

  • Principal Investigator: Rachel Grisham, MD, GOG Foundation
  • Principal Investigator: Susana Banerjee, MBBS, MA, PhD, European Network of Gynecological Oncological Trial Groups (ENGOT)
  • Study Director: Craig Berman Verastem Medical Monitor, RAMP301@verastem.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2024

Primary Completion (Estimated)

October 15, 2028

Study Completion (Estimated)

February 9, 2031

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VS-6766-301
  • GOG-3097 (Other Identifier: The GOG Foundation, Inc.)
  • ENGOT-ov81 (Other Identifier: ENGOT)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Grade Serous Ovarian Cancer

Clinical Trials on Paclitaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe