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New hope for rare ovarian cancer: drug combo targets tumor growth

NCT ID NCT06072781

Disease control Sponsor: Verastem, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 6 times

Summary

This study tests whether a combination of two drugs (avutometinib and defactinib) works better than standard treatments for people with recurrent low-grade serous ovarian cancer. About 270 participants whose cancer returned after platinum-based therapy will be randomly assigned to receive either the new combination or a standard treatment. The main goal is to see if the new combination delays cancer progression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 270 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

borderline ovarian serous tumor ovarian serous adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Low-grade serous ovarian cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    104 sites in 16 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AO Cannizzaro

    RECRUITING

    Catania, 95126, Italy

  • Aalborg U.H

    RECRUITING

    Aalborg, 9000, Denmark

  • AdventHealth

    RECRUITING

    Orlando, Florida, 32804, United States

  • Agaplesion Markus Krankenhaus

    RECRUITING

    Frankfurt am Main, Hesse, 60431, Germany

  • Aichi Cancer Center Hospital

    RECRUITING

    Aichi, Nagoya, 464-8681, Japan

  • Allegheny Health Network

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Asplundh Cancer Pavilion | Jefferson Health

    RECRUITING

    Philadelphia, Pennsylvania, 19090, United States

  • Atrium Health

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Auckland City Hospital

    RECRUITING

    Auckland, 1023, New Zealand

  • Białostockie Centrum Onkologii

    RECRUITING

    Bialystok, 15-027, Poland

  • British of Columbia

    RECRUITING

    Vancouver, V5Z 4E6, Canada

  • Cambridge University Hospital

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Cancer Research South Australia

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Centre Hospitalier de Besançon

    RECRUITING

    Besançon, 25000, France

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    RECRUITING

    Montreal, Quebec, H2X 0C1, Canada

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69373, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, 59020, France

  • Centro di Riferimento Oncologico (CRO)

    RECRUITING

    Aviano, 33081, Italy

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, 13353, Germany

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clínico Virgen de La Arrixaca

    RECRUITING

    El Palmar, Murcia, 30120, Spain

  • European Institute of Oncology (IEO)

    RECRUITING

    Milan, Italy

  • Florida Cancer Specialists - South

    RECRUITING

    Fort Myers, Florida, 33901, United States

    Contact Email: •••••@•••••

  • Florida Cancer Specialists Research East

    RECRUITING

    West Palm Beach, Florida, 33401, United States

    Contact Email: •••••@•••••

  • Gangnam Severance Hospital

    RECRUITING

    Seoul, 06273, South Korea

  • Gdański Uniwersytet Medyczny

    RECRUITING

    Gdansk, 80-214, Poland

  • Greater Glasgow and Clyde (GGC)

    RECRUITING

    Glasgow, Scotland, G120YN, United Kingdom

  • H. Vall d´ Hebron

    RECRUITING

    Barcelona, Spain

  • H. de Donostia

    RECRUITING

    Donostia / San Sebastian, San Sebastian, 20014, Spain

  • H.U. Ramón y Cajal

    RECRUITING

    Madrid, Spain

  • HonorHealth

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Hope Cancer Trials Centre

    RECRUITING

    Leicester, LE2 7LX, United Kingdom

  • Hospital Clínico Universitario de Santiago

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

    Contact Email: •••••@•••••

  • Hospital Universitario Reina Sofía

    RECRUITING

    Córdoba, Spain

  • Houston Methodist

    RECRUITING

    Houston, Texas, 77030, United States

  • Humanitas San Pio X

    RECRUITING

    Milan, 20159, Italy

  • INT Napoli Hospital

    RECRUITING

    Naples, Italy

  • IRCCS Gemelli

    RECRUITING

    Roma, 00168, Italy

  • Icon Cancer Centre Wesley

    RECRUITING

    Auchenflower, Queensland, 4066, Australia

    Contact Email: •••••@•••••

  • Institut Curie

    RECRUITING

    Paris, France

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • Istituti Fisioterapici Ospitalieri

    RECRUITING

    Rome, 00144, Italy

  • Istituto Nazionale dei Tumori

    RECRUITING

    Milan, 20133, Italy

  • Istituto Oncologico Veneto (IOV)

    RECRUITING

    Padova, 35128, Italy

  • Karmanos Cancer Center

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Kliniken Essen-Mitte

    RECRUITING

    Essen, 45136, Germany

  • Louisiana State University

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Minnesota Oncology Hematology

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Mount Sinai

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • Netherlands Cancer Insitute

    RECRUITING

    Amsterdam, 1066, Netherlands

  • NorthShore University HealthSystem

    RECRUITING

    Evanston, Illinois, 60201, United States

  • Northwest Cancer Specialists

    RECRUITING

    Portland, Oregon, 97227, United States

  • Ohio State

    RECRUITING

    Hilliard, Ohio, 43026, United States

  • Osaka Medical Center

    RECRUITING

    Osaka, Japan

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Prince of Wales Hospital

    RECRUITING

    Randwick, New South Wales, 2031, Australia

  • Princess Margaret Cancer Center

    RECRUITING

    Toronto, Ontario, M5G 1X6, Canada

  • Radboud UMC

    RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Roswell Park Cancer Institute

    ACTIVE_NOT_RECRUITING

    Buffalo, New York, 14263, United States

  • Royal Marsden Hospital

    RECRUITING

    London, SW7 3RP, United Kingdom

  • Royal Marsden Hospital

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • S.C.D.U. Oncologia

    RECRUITING

    Torino, 10128, Italy

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • San Raffaele Hospital

    RECRUITING

    Milan, 20132, Italy

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, 13620, South Korea

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    RECRUITING

    Baltimore, Maryland, 21287, United States

    Contact Email: •••••@•••••

  • Siedleckie Centrum Onkologii

    RECRUITING

    Siedlce, 98-110, Poland

  • Sir Charles Gairdner Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Site Georges François Leclerc

    RECRUITING

    Dijon, 21079, France

  • Spedali Civili

    RECRUITING

    Brescia, 25123, Italy

  • St. James's Hospital

    RECRUITING

    Dublin, 08, Ireland

  • Texas Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Texas Oncology

    RECRUITING

    The Woodlands, Texas, 77380, United States

  • Texas Oncology

    RECRUITING

    Tyler, Texas, 75702, United States

  • Texas Oncology Central

    RECRUITING

    Austin, Texas, 78731, United States

  • Texas Oncology-Fort Worth Cancer Center

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, United Kingdom

  • The Jikei University Hospital

    RECRUITING

    Tokyo, 3-19-18, Japan

  • The Mie University Hospital

    RECRUITING

    Tsu, Mie-ken, 514-8507, Japan

  • Tohoku University Hospital

    RECRUITING

    Miyagi, 980-8574, Japan

  • UC Davis

    RECRUITING

    Sacramento, California, 95817, United States

  • UCLA Health

    RECRUITING

    Los Angeles, California, 90095, United States

  • UMC Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • UZA

    RECRUITING

    Edegem, 2650, Belgium

  • University College London Hospitals NHS Foundation Trust

    RECRUITING

    London, NW1 2PG, United Kingdom

  • University Hospital Ghent

    RECRUITING

    Ghent, 9000, Belgium

  • University of Arkansas

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of California, San Francisco

    ACTIVE_NOT_RECRUITING

    San Francisco, California, 94143, United States

  • University of Edinburgh Cancer Research Centre

    RECRUITING

    Edinburgh, United Kingdom

  • University of Oklahoma Medical Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Virginia Health System

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Universitätsfrauenkinik Ulm

    RECRUITING

    Ulm, 89075, Germany

  • Universitätsklinikum Carl Gustav Carus

    RECRUITING

    Dresden, 01307, Germany

  • Universitätsklinikum Mannheim GmbH

    RECRUITING

    Mannheim, 68167, Germany

  • Virginia Cancer Specialists, PC

    RECRUITING

    Gainesville, Virginia, 20155, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Willamette Valley Cancer Institute

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Winship Cancer Institute at Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

  • Yonsei University Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

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