AzTrials
AzTrials

Low Grade Serous Ovarian CancerPhase 3RAMP 301NCT06072781

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

A Phase 3 study testing avutometinib, Defactinib and Pegylated liposomal doxorubicin in people with Low Grade Serous Ovarian Cancer, run by Verastem, Inc. at 105 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Low Grade Serous Ovarian Cancer
What is being tested?
avutometinib, Defactinib and Pegylated liposomal doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
105 sitesin 16 countries
Study dates
18 Mar 2024to 9 Feb 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Patients will be excluded from the study if they meet any of the following criteria:
  • Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
  • Co-existing high-grade serous ovarian cancer or mixed histology.
  • Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
  • History of prior malignancy with recurrence <3 years from the time of enrollment.
  • Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week of the first dose of study intervention.
Show all 18Show fewer
  • Symptomatic brain metastases requiring steroids or other interventions, known leptomeningeal metastases, or spinal cord compression.
  • An active skin disorder that has required systemic therapy within one year of the first dose of study intervention.
  • History of medically significant rhabdomyolysis.
  • For subjects with prior MEK or RAF exposure, Grade 4 toxicity is deemed related to the MEK inhibitor.
  • Symptomatic bowel obstruction within 3 months of the first dose of study intervention
  • Concurrent ocular disorders.
  • Concurrent heart disease or severe obstructive pulmonary disease.
  • Active or past medical history of interstitial lung disease/pneumonitis, including drug-induced or radiation pneumonitis, pulmonary fibrosis, or adult respiratory distress syndrome (ARDS).
  • Subjects with the inability to swallow oral medications.
  • 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.
  • Pregnant or breastfeeding.
  • Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.

Trial locations and contacts

105 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

Verastem Call Center contact

781-292-4204

RAMP301TrialSupport@verastem.com

105 sites in 16 countries

United States38 sites, 36 recruiting

  • Winship Cancer Institute at Emory University

    Atlanta, Georgia, 30322

    Syed Ahsan, syed.atif.ahsan@emory.edu

    Susan Modesitt, MD

    Recruiting

  • Texas Oncology Central

    Austin, Texas, 78731

    Michelle Owens, michelle.owens@usoncology.com

    Lynn Knowles, MD

    Recruiting

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287

    Faith Too, ftoo1@jhmi.edu

    HopkinsGynTrials@jhmi.edu

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Active, not recruiting

  • Atrium Health

    Charlotte, North Carolina, 28203

    Melani Terry, Melani.Terry@atriumhealth.org

    Erin Crane, MD

    Recruiting

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

    Alexa Pittaro, AMP7BSH@uvahealth.org

    Kari Ring, MD

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Jacqueline Ludwig, ludwigj@ccf.org

    Peter Rose, MD

    Recruiting

  • Karmanos Cancer Center

    Detroit, Michigan, 48201

    Elizabeth Linnik, linnike@karmanos.org

    Robert Morris, MD

    Recruiting

  • Willamette Valley Cancer Institute

    Eugene, Oregon, 97401

    Jeanne Scahffer, jeanne.schaffer@usoncology.com

    Charles Anderson, MD

    Recruiting

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

    Michele Britto, mbritto@northshore.org

    Mary Tilley Jenkins-Vogel, MD

    Recruiting

  • Florida Cancer Specialists - South

    Fort Myers, Florida, 33901

    Christina Caruso, clinicaltrials@flcancer.com

    Elizabeth Guancial, MD

    Recruiting

  • Texas Oncology-Fort Worth Cancer Center

    Fort Worth, Texas, 76104

    Nori Sullivan, nori.sullivan@usoncology.com

    Noelle Cloven, MD

    Recruiting

  • Virginia Cancer Specialists, PC

    Gainesville, Virginia, 20155

    Monica Cochrane, monica.cochrane@usoncology.com

    Robert Marsh, MD

    Recruiting

  • Ohio State

    Hilliard, Ohio, 43026

    Jordyn Burks, Jordyn.Burks@osumc.edu

    Christa Nagel, MD

    Recruiting

  • Houston Methodist

    Houston, Texas, 77030

    Konny Chan Fong, 346-238-5815, klchanfong@houstonmethodist.org

    Aparna Kamat, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Kelly Rangel, (713) 745-2553, kshea@mdanderson.org

    Lauren Cobb, MD

    Recruiting

  • University of Arkansas

    Little Rock, Arkansas, 72205

    Kathryn Allen, KGAllen@uams.edu

    Heather Williams, MD

    Recruiting

  • UCLA Health

    Los Angeles, California, 90095

    Chika Obiora, CObiora@mednet.ucla.edu

    Ritu Salani, MD

    Recruiting

  • Mount Sinai

    Miami Beach, Florida, 33140

    Antonio Ramirez Riderelli, Antonio.RamirezRiderelli@msmc.com

    Brian Slomovitz, MD

    Recruiting

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404

    Kayla McDonald, kayla.mcdonald1@usoncology.com

    Lauren Bollinger, MD

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, 84107

    Stacy Howard, stacy.howard@imail.org

    Ying Ning, MD

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Lisa Baker, lisa.baker@yale.edu

    Alessandro Santin, MD

    Recruiting

  • Louisiana State University

    New Orleans, Louisiana, 70112

    Alex Yates, ayate2@lsuhsc.edu

    Amelia Jernigan, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Rachel Grisham, 6468884653

    Rachel Grisham, MD

    Recruiting

  • University of Oklahoma Medical Center

    Oklahoma City, Oklahoma, 73104

    Liz Barrett, Elizabeth-Barrett@ouhsc.edu

    Christina Washington, MD

    Recruiting

  • AdventHealth

    Orlando, Florida, 32804

    Karla Hernandez-Cruz, Karla.Hernandez-Cruz@AdventHealth.com

    Robert Holloway, MD

    Recruiting

  • Asplundh Cancer Pavilion | Jefferson Health

    Philadelphia, Pennsylvania, 19090

    Ashley Douglas, ashley.douglas.2@jefferson.edu

    Mitchell Edelson, MD

    Recruiting

  • HonorHealth

    Phoenix, Arizona, 85016

    Nathan Solod, nsolod@honorhealth.com

    Lyndsay Willmott, MD

    Recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15224

    Thomas Krivak, 412-578-1116 ext. 2, thomas.krivak@ahn.org

    Thomas Krivak, MD

    Recruiting

  • Northwest Cancer Specialists

    Portland, Oregon, 97227

    Jennifer Thompson, Jennifer.Thompson@usoncology.com

    Erin Salinas, MD

    Recruiting

  • UC Davis

    Sacramento, California, 95817

    Leslie Garcia, lesgarcia@ucdavis.edu

    Hui Amy Chen, MD

    Recruiting

  • Texas Oncology

    San Antonio, Texas, 78229

    Shannon Syring, shannon.syring@usoncology.com

    Antonio Santillan Gomez, MD

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Active, not recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Linda Odibo, odibol@wustl.edu

    Premal Thaker, MD

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Tiffany Shiles, tiffany.shiles@moffitt.org

    Jenny Newman, jennifer.newman@moffitt.org

    Recruiting

  • Texas Oncology

    The Woodlands, Texas, 77380

    Christina Genthon, Christina.Genthon@usoncology.com

    Sandra Thornton, Sandra.Thornton@usoncology.com

    Recruiting

  • Texas Oncology

    Tyler, Texas, 75702

    Shelly Maxfield, shelly.maxfield@usoncology.com

    Anna M Priebe, MD

    Recruiting

  • Florida Cancer Specialists Research East

    West Palm Beach, Florida, 33401

    Mary Jo Luser, clinicaltrials@flcancer.com

    Bradley Monk, MD

    Recruiting

Other trials in United States

Italy11 sites, 11 recruiting

  • Centro di Riferimento Oncologico (CRO)

    Aviano, 33081

    Serena Corsetti, +390434399077, serena.corsetti@cro.it

    Michelle Bartoletti, MD

    Recruiting

  • AO Cannizzaro

    Catania, 95126

    Francesca Salanitro, +39 0957262165, fra.salanitro@gmail.com

    Alessandra Paggin, alepaggin@hotmail.com

    Recruiting

  • San Raffaele Hospital

    Milan, 20132

    Silvia Pagani, pagani.silvia@hsr.it

    Giorgia Mangili, MD

    Recruiting

  • Humanitas San Pio X

    Milan, 20159

    Ilaria Sabatucci, ilaria.sabatucci@sanpiox.humanitas.it

    Domenica Lorusso, MD

    Recruiting

  • European Institute of Oncology (IEO)

    Milan

    Giovanna Spano, giovanna.spano@ieo.it

    Nicoletta Columbo, MD

    Recruiting

  • Istituto Nazionale dei Tumori

    Milan, 20133

    Barbara Montesanto, 39 0223903619, barbara.montesanto@istitutotumori.mi.it

    Mara Mantiero, MD

    Recruiting

  • INT Napoli Hospital

    Naples

    Margherita Tambaro, m.tambaro@istitutotumori.na.it

    Sabrina Cecere, MD

    Recruiting

  • Istituto Oncologico Veneto (IOV)

    Padova, 35128

    Giulia Doria, giulia.doria@iov.veneto.it

    Valentina Guarneri, MD

    Recruiting

  • IRCCS Gemelli

    Roma, 00168

    Giulia Ponti, 630158545, giulia.ponti@policlinicogemelli.it

    Vanda Salutari, MD

    Recruiting

  • Istituti Fisioterapici Ospitalieri

    Rome, 00144

    Agnese Provenziani, agnese.provenziani@ifo.it

    Savarese Antonella, MD

    Recruiting

  • S.C.D.U. Oncologia

    Torino, 10128

    Giorgio Valabrega, 115085529, giorgio.valabrega@unito.it

    Giorgio Valabrega, MD

    Recruiting

Other trials in Italy

United Kingdom8 sites, 8 recruiting

  • Cambridge University Hospital

    Cambridge, CB2 0QQ

    Regulatory Team, cuh.research@nhs.net

    Joo Ern Ang, MD

    Recruiting

  • University of Edinburgh Cancer Research Centre

    Edinburgh

    Olga Demyanov, olga.demyanov@nhs.scot

    Charlie Gourley, MD

    Recruiting

  • Greater Glasgow and Clyde (GGC)

    Glasgow, Scotland, G120YN

    Ros Glasspool, MD, ros.glasspool@ggc.scot.nhs.uk

    Ros Glasspool, MD

    Recruiting

  • Hope Cancer Trials Centre

    Leicester, LE2 7LX

    Joey Wood, MD, 0116 258 5750, joey.wood@uhl-tr.nhs.uk

    Joey Wood, MD

    Recruiting

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG

    Christian Paul Medina, christianpaul.medina@nhs.net

    Shibani Nicum, MD, snicum@nhs.net

    Recruiting

  • Royal Marsden Hospital

    London, SW7 3RP

    Kylie Fitch, Kylie.Fitch@rmh.nhs.uk

    Susana Banerjee, MD

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester

    Linzi Davies, linzi.davies@nhs.net

    Andrew Clamp, MD

    Recruiting

  • Royal Marsden Hospital

    Sutton, SM2 5PT

    Kylie Fitch, Kylie.Fitch@rmh.nhs.uk

    Susana Banerjee, MD

    Recruiting

Other trials in United Kingdom

Germany7 sites, 7 recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353

    Radoslav Chekerov, MD, radoslav.chekerov@charite.de

    Elena Ioana Braicu, MD, elena.braicu@charite.de

    Recruiting

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307

    Theresa Link, Theresa.link@uniklinikum-dresden.de

    Pauline Wimberger, MD

    Recruiting

  • Kliniken Essen-Mitte

    Essen, 45136

    Anna Kasperek, A.Kasperek@kem-med.com

    Philipp Harter, MD

    Recruiting

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main, Hesse, 60431

    Madeleine Modrow, 0049 9533 66754, madeleine.modrow@agaplesion.de

    Marc Thill, MD

    Recruiting

  • UMC Hamburg-Eppendorf

    Hamburg, 20246

    Juliane Granzow, 040 7410 - 52396, j.granzow@uke.de

    Barbara Schmalfeldt, MD

    Recruiting

  • Universitätsklinikum Mannheim GmbH

    Mannheim, 68167

    Melanie Breitbarth, Melanie.Breitbarth@umm.de

    Frederik Marmé, MD

    Recruiting

  • Universitätsfrauenkinik Ulm

    Ulm, 89075

    Wolfgang Janni, 004973150058520, Janni_Studien.UFK@uniklinik-ulm.de

    Fabienne Schochter, MD

    Recruiting

Other trials in Germany

Spain7 sites, 7 recruiting

  • H. Vall d´ Hebron

    Barcelona

    Olga Padros, opadros@vhio.net

    Ana Oaknin, MD

    Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba

    Asuncion Aranda, asuncion.aranda21@gmail.com

    Maria Jesus Rubio, MD

    Recruiting

  • H. de Donostia

    Donostia / San Sebastian, San Sebastian, 20014

    Cristina Maria Churruca Galaz, 34 943 32 81 51, cristinamaria.churrucagalaz@osakidetza.eus

    Cristina Maria Churruca Galaz, MD

    Recruiting

  • Clínico Virgen de La Arrixaca

    El Palmar, Murcia, 30120

    Ana Puertes Boix, 34 968 369 516, ana.puertes@carm.es

    Ana Puertes Boix, MD

    Recruiting

  • H.U. Ramón y Cajal

    Madrid

    María Cantón Navarro, (+34) 91 336 82 63 ext. 91 336 91, maria.canton@salud.madrid.org

    Rosa María Aras López, (+34) 91 336 82 63 ext. 91 336 91, rosam.aras@salud.madrid.org

    Recruiting

  • Hospital Clínico Universitario de Santiago

    Santiago de Compostela, 15706

    Iria Portos Conde, +34981 950 511, iriaportos.onco@gmail.com

    Juan Cueva Bañuelos, MD

    Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

    Paloma Campos Bañegil, infopacientesonceecc@incliva.es

    Alejandro Perez Fidalgo, MD

    Recruiting

Other trials in Spain

Australia5 sites, 5 recruiting

  • Cancer Research South Australia

    Adelaide, South Australia, 5000

    Vineet Kwatra, MD, vkwatra@crsa.au

    Meena Okera, MD

    Recruiting

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, 4066

    Amy Morrow, researchwesley@icon.team

    Jeffrey Goh, MD

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

    Nicole Marsh, nicole.marsh@petermac.org

    Sumitra Ananda, MD

    Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

    Jolanta Damas, Jolanta.Damas1@health.wa.gov.au

    Tarek Meniawy, MD

    Recruiting

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

    Kaye Kongrak, Kamonwan.Kongrak@health.nsw.gov.au

    Yeh Chen Lee, MD

    Recruiting

Other trials in Australia

France5 sites, 5 recruiting

  • Centre Hospitalier de Besançon

    Besançon, 25000

    Ophélie Sivignon, osivignon@chu-besancon.fr

    Laura Mansi, MD

    Recruiting

  • Site Georges François Leclerc

    Dijon, 21079

    Kevin Le Berre, kleberre@cgfl.fr

    Jean-David Fumet, MD

    Recruiting

  • Centre Oscar Lambret

    Lille, 59020

    Clémence Goetz, c-goetz@o-lambret.fr

    Cyril Abdeddaim, MD

    Recruiting

  • Centre Léon Bérard

    Lyon, 69373

    Emilie Repetto, MD, Emilie.REPETTO@lyon.unicancer.fr

    Isabelle Ray-Coquard, MD

    Recruiting

  • Institut Curie

    Paris

    Manuel Rodrigues, MD, 0033 1 56 24 56 42, manuel.rodrigues@curie.fr

    Recruiting

Other trials in France

Japan5 sites, 5 recruiting

  • Aichi Cancer Center Hospital

    Aichi, Nagoya, 464-8681

    Shiro Suzuki, +81-52-762-6111, s.suzuki@aichi-cc.jp

    Shiro Suzuki, MD

    Recruiting

  • Tohoku University Hospital

    Miyagi, 980-8574

    Shogo Shigeta, shogo.shigeta.a4@tohoku.ac.jp

    Shogo Shigeta

    Recruiting

  • Osaka Medical Center

    Osaka

    Satoe Fujiwara, satoe.fujiwara@ompu.ac.jp

    Satoe Fujiwara, MD

    Recruiting

  • The Jikei University Hospital

    Tokyo, 3-19-18

    Nozomu Yanaihara, yanazou@outlook.com

    Nozomu Yanaihara, MD

    Recruiting

  • The Mie University Hospital

    Tsu, Mie-ken, 514-8507

    Eiji Kondo, eijikon@clin.medic.mie-u.ac.jp

    Eiji Kondo, MD

    Recruiting

Other trials in Japan

South Korea5 sites, 5 recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 13620

    Kidong Kim, 010-6275-7691; 82-31-787-7262, kidong.kim.md@gmail.com

    Kidong Kim, MD

    Recruiting

  • Yonsei University Severance Hospital

    Seoul, 03722

    Sang Wun Kim, 010-7209-8433; 02-2228-2230, san1@yuhs.ac

    Sang Wun Kim, MD

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Geum Hee Na, goldnah@naver.com

    Shin Wah Lee, MD

    Recruiting

  • Gangnam Severance Hospital

    Seoul, 06273

    Mina Jang, 82-10-8737-0811, MNJ2023SC@yuhs.ac

    Jae-Hoon Kim, 010-5276-2742; 02-2019-3436, jaehoonkim@yuhs.ac

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Jung Eun Park, 82-10-6264-6923, jjjeun.park@sbri.co.kr

    Chel Hun Choi, 010-9933-5151, chelhun.choi@samsung.com

    Recruiting

Other trials in South Korea

Canada4 sites, 4 recruiting

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

    Montreal, Quebec, H2X 0C1

    Nathalie Grenier, nathalie.grenier.chum@ssss.gouv.qc.ca

    Diane Provencher, MD

    Recruiting

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

    Phuong Nam Nathalie Nguyen, phuong-nam.nguyen@muhc.mcgill.ca

    Lucy Gilbert, MD

    Recruiting

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 1X6

    Valerie Bowering, valerie.bowering@uhn.ca

    Amit Oza, MD

    Recruiting

  • British of Columbia

    Vancouver, V5Z 4E6

    Fran Topp, RN, ftopp@bccancer.bc.ca

    Anna Tinker, MD

    Recruiting

Other trials in Canada

Poland3 sites, 3 recruiting

  • Białostockie Centrum Onkologii

    Bialystok, 15-027

    Justyna Sławińska, 573 424 968, jslawinska@onkologia.bialystok.pl

    Beata Maćkowiak-Matejczyk, MD

    Recruiting

  • Gdański Uniwersytet Medyczny

    Gdansk, 80-214

    Łukasz Jędrzejewski, 48585846103, ljedrzejewski@uck.gda.pl

    Dagmara Klasa-Mazurkiewicz, MD

    Recruiting

  • Siedleckie Centrum Onkologii

    Siedlce, 98-110

    Tomasz Milewski, tmilewski@szpital.siedlce.pl

    Małgorzata Będkowska, mbedkowska@szpital.siedlce.pl

    Recruiting

Other trials in Poland

Belgium2 sites, 2 recruiting

  • UZA

    Edegem, 2650

    Griet Wyers, + 32 3 821 57 43, griet.wyers@uza.be

    Konstantinos Papadimitriou, MD

    Recruiting

  • University Hospital Ghent

    Ghent, 9000

    Hannelore Denys, MD, +32 9 332 26 92, Hannelore.denys@ugent.be

    Hannelore Denys, MD

    Recruiting

Other trials in Belgium

Netherlands2 sites, 2 recruiting

  • Netherlands Cancer Insitute

    Amsterdam, 1066

    Geesje Feingold - van Olst, g.v.olst@nki.nl

    Frans Opdam

    Recruiting

  • Radboud UMC

    Nijmegen, 6525 GA

    Daphne van Dijk, daphne.vandijk@radboudumc.nl

    Nelleke Ottevanger, MD

    Recruiting

Other trials in Netherlands

Denmark1 site, 1 recruiting

  • Aalborg U.H

    Aalborg, 9000

    Mette Raaschou, 4597661291, mera@rn.dk

    Charlotte A Haslund, MD

    Recruiting

Other trials in Denmark

Ireland1 site, 1 recruiting

  • St. James's Hospital

    Dublin, 08

    Lauren Murphy, +353 (01) 428 4934, LaurMurphy@stjames.ie

    Karen Cadoo, MD

    Recruiting

Other trials in Ireland

New Zealand1 site, 1 recruiting

  • Auckland City Hospital

    Auckland, 1023

    Merina Mathews, MerinaM@adhb.govt.nz

    Michelle Wilson, MD

    Recruiting

Other trials in New Zealand

About this study

Official title: 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.

Read the 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)

Being tested
avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Keywords
Low Grade Serous Ovarian Cancer, KRAS, KRAS wt, KRAS mt

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • avutometinibDrug

    Also called avutometinib (VS-6766)

    Avutometinib: administered orally

  • DefactinibDrug

    Also called defactinib (VS-6063)

    Defactinib: administered orally

  • Pegylated liposomal doxorubicinDrug

    Also called Caelyx, Doxil, Lipodox

    administered intravenously

  • PaclitaxelDrug

    Also called Nov-Onxol, Onxol, Navaplus, Taxol

    administered intravenously

  • LetrozoleDrug

    Also called Femara

    administered orally

  • AnastrozoleDrug

    Also called Arimidex

    administered orally

Study groups in NCT06072781
Study groupRoleWhat they receive
avutometinib + defactinibExperimentalAvutometinib 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.
Receives: Drug: avutometinib; Drug: Defactinib
Investigator Choice of Treatment (ICT)Active comparatorPatients 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.
Receives: Drug: Pegylated liposomal doxorubicin; Drug: Paclitaxel; Drug: Letrozole; Drug: Anastrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) per blinded independent central review (BICR)

    Progression-free survival (PFS) according to RECIST version 1.1, per blinded independent central review (BICR)

    Measured: Up to 24 months

Secondary outcomes (11)

  1. Overall Survival (OS)

    From the time of first dose of study intervention to PD as assessed per RECIST 1.1 or death from any cause

    Measured: Up to 5 years

  2. Progression Free Survival (PFS) per investigator assessment

    Progression-free survival (PFS) according to RECIST version 1.1, per blinded independent central review (BICR)

    Measured: 24 months

  3. Objective response rate (ORR)

    From the time of first dose of study intervention to PD as assessed per RECIST 1.1 by Investigator or death from any cause

    Measured: 12 months

  4. Duration of Response (DOR)

    From the time of first dose of study intervention to PD as assessed per RECIST 1.1 by Investigator or death from any cause

    Measured: 12 months

  5. Disease Control Rate (DCR)

    CR+PR+Stable disease

    Measured: 6 months

  6. Frequency and severity adverse events (AEs) and Serious Adverse Events (SAEs)

    Count of AE and SAEs by grade, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading scale

    Measured: 25 months

  7. Area under the plasma concentration-time curve (AUC) of avutometinib, defactinib and relative metabolites

    Area under plasma Concentration (AUC) 0 to t

    Measured: 5 months

  8. Maximum plasma concentration (Cmax) of avutometinib, defactinib and relative metabolites

    maximum plasma concentration

    Measured: 5 months

  9. 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).

    The EORTC QLQ-C30 is a validated questionnaire to assess the quality of life of ovarian cancer patients.

    Measured: 24 months

  10. 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).

    The EORTC QLQ-OV28 is a validated questionnaire to assess the quality of life of ovarian cancer patients.

    Measured: 24 months

  11. To assess the health-related quality of life and disease based on EuroQol-5 Dimension 5-level (EQ-5D-5L)

    The EuroQol-5 Dimension 5-level (EQ-5D-5L) is a validated questionnaire used to measure a patient's overall health.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start18 Mar 2024
  3. Primary completion15 Oct 2028 (estimated)
  4. Study completion9 Feb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06072781
Sponsor's protocol ID
VS-6766-301
Other IDs
GOG-3097, ENGOT-ov81
Acronym
RAMP 301
Status last verified
Oct 2026
First submitted
2 Oct 2023
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Banerjee SN, Van Nieuwenhuysen E, Aghajanian C, D'Hondt V, Monk BJ, Clamp A, Prendergast E, Oaknin A, Ring K, Colombo N, Holloway RW, Rodrigues M, Chon HS, Gourley C, Santin AD, Thaker PH, Gennigens C, Newman G, Salinas E, Youssoufian H, Moore KN, Lustgarten S, O'Malley DM, Van Gorp T, Grisham RN. The combination of avutometinib and defactinib in treating recurrent low-grade serous ovarian cancer: a plain language summary of the Phase II clinical trial ENGOT-OV60/GOG-3052/RAMP 201. Future Oncol. 2025 Dec;21(30):3859-3871. doi: 10.1080/14796694.2025.2595130. Epub 2025 Dec 12.

    PubMed 41384753

  • Banerjee SN, Van Nieuwenhuysen E, Aghajanian C, D'Hondt V, Monk BJ, Clamp A, Prendergast E, Oaknin A, Ring K, Colombo N, Holloway RW, Rodrigues M, Chon HS, Gourley C, Santin AD, Thaker PH, Gennigens C, Newman G, Salinas E, Youssoufian H, Moore KN, Lustgarten S, O'Malley DM, Van Gorp T, Grisham RN. Efficacy and Safety of Avutometinib +/- Defactinib in Recurrent Low-Grade Serous Ovarian Cancer: Primary Analysis of ENGOT-OV60/GOG-3052/RAMP 201. J Clin Oncol. 2025 Sep;43(25):2782-2792. doi: 10.1200/JCO-25-00112. Epub 2025 Jul 11.

    PubMed 40644648

  • Grisham R, Monk BJ, Van Nieuwenhuysen E, Moore KN, Fabbro M, O'Malley DM, Oaknin A, Thaker P, Oza AM, Colombo N, Gershenson D, Aghajanian CA, Choi CH, Lee YC, Mirza MR, Coleman RL, Cobb L, Harter P, Lustgarten S, Youssoufian H, Banerjee S. GOG-3097/ENGOT-ov81/GTG-UK/RAMP 301: a phase 3, randomized trial evaluating avutometinib plus defactinib compared with investigator's choice of treatment in patients with recurrent low grade serous ovarian cancer. Int J Gynecol Cancer. 2025 Nov;35(11):101832. doi: 10.1136/ijgc-2024-005919. Epub 2025 Apr 19.

    PubMed 39375168

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing avutometinib, Defactinib and Pegylated liposomal doxorubicin in people with Low Grade Serous Ovarian Cancer, run by Verastem, Inc. at 105 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Italy, United Kingdom, Germany, Spain and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Verastem Call Center (781-292-4204, RAMP301TrialSupport@verastem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) per blinded independent central review (BICR) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06072781, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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RAMP 301 Clinical Trial NCT06072781 | AzTrials