Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

Summary

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.

Interventions

• daraxonrasib · DRUG

  oral tablets

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* At least 18 years old and has provided informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Histologically confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease.
* Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy.
* Must have completed most recent treatment within the past 12 weeks.
* Adequate organ function (bone marrow, liver, kidney, coagulation).
* Documented RAS mutation status.
* Able to take oral medications.

Exclusion Criteria:

* Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
* Any conditions that may affect the ability to take or absorb study drug.
* Major surgery within 28 days prior to randomization.
* Patient is unable or unwilling to comply with protocol-required study visits or procedures.

Sites (66)

• Mayo Clinic, Phoenix, Arizona · RECRUITING
• UC San Diego Moores Cancer Center, La Jolla, California · RECRUITING
• Cedars-Sinai Cancer at Cedars-Sinai Medical Center, Los Angeles, California · RECRUITING
• University of California, Los Angeles, Los Angeles, California · RECRUITING
• Stanford Cancer Institute, Palo Alto, California · RECRUITING
• University of California, San Francisco, San Francisco, California · RECRUITING
• Rocky Mountain Cancer Centers, LLP, Lakewood, Colorado · RECRUITING
• Hartford Healthcare, Hartford, Connecticut · RECRUITING
• Mayo Clinic, Jacksonville, Florida · RECRUITING
• University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center, Miami, Florida · RECRUITING
• Florida Cancer Specialists, St. Petersburg, Florida · RECRUITING
• Winship Cancer Institute, Emory University, Atlanta, Georgia · RECRUITING
• Community Health Network, Indianapolis, Indiana · RECRUITING
• University of Kansas Medical Center Research Institute, Inc., Lawrence, Kansas · RECRUITING
• Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins & Sibley Memorial Hospital, Baltimore, Maryland · RECRUITING
• Massachusetts General Hospital, Boston, Massachusetts · RECRUITING
• Dana Farber Cancer Institute (DFCI), Boston, Massachusetts · RECRUITING
• Mayo Clinic Cancer Center, Rochester, Minnesota · RECRUITING
• Saint Luke's Cancer Institute, Kansas City, Missouri · RECRUITING
• University of Nebraska Medical Center, Omaha, Nebraska · RECRUITING
• Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada · RECRUITING
• Laura and Issac Perlmutter Cancer Center at NYU Langone-Ambulatory Care Center, New York, New York · RECRUITING
• Columbia University Medical Center, New York, New York · RECRUITING
• Memorial Sloan Kettering Cancer Center, New York, New York · RECRUITING
• University of Rochester Medical Center, Rochester, New York · RECRUITING
• Duke Cancer Center, Durham, North Carolina · RECRUITING
• Taylor Cancer Research Center, Maumee, Ohio · RECRUITING
• Avera Cancer Institute, Sioux Falls, South Dakota · RECRUITING
• SCRI Oncology Partners, Nashville, Tennessee · RECRUITING
• Texas Oncology - DFW, Dallas, Texas · RECRUITING
• University of Texas MD Anderson Cancer Center, Houston, Texas · NOT_YET_RECRUITING
• Texas Oncology - Northeast Texas, Longview, Texas · RECRUITING
• University of Utah, Huntsman Cancer Institute, Salt Lake City, Utah · RECRUITING
• Virginia Cancer Specialists, Fairfax, Virginia · RECRUITING
• Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin · RECRUITING
• CRLCC Eugene Marquis, Rennes, Cedex, France · RECRUITING
• Hôpital Paul Brousse, Villejuif, Val-De- Marne, France · RECRUITING
• Institut Gustave Roussy, Villejuif, Val-de-Marne, France · RECRUITING
• Institut Paoli Calmettes, Marseille, France · RECRUITING
• Universitaetsklinikum Heidelberg, Heidelberg, Germany · RECRUITING
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy · RECRUITING
• IEO - Instituto Europeo di Oncologia, Milan, Italy · RECRUITING
• IOV - Istituto Oncologico Veneto IRCCS, Padova, Italy · RECRUITING
• Azienda Ospedaliero Universitaria Pisana, Pisa, Italy · RECRUITING
• Centro Ricerche Cliniche di Verona s.r.l., Verona, Italy · RECRUITING
• Kanagawa Cancer Center, Yokohama, Kanagawa, Japan · RECRUITING
• National Cancer Center Hospital East, Chiba, Japan · RECRUITING
• Kyoto University Hospital, Kyoto, Japan · RECRUITING
• National Cancer Center Hospital, Tokyo, Japan · RECRUITING
• Cancer Institute Hospital of JFCR, Tokyo, Japan · RECRUITING
• Pan American Oncology Trials, LLC, San Juan, Puerto Rico · RECRUITING
• Dong-A University Hospital, Busan, South Korea · RECRUITING
• Seoul National University Hospital, Seoul, South Korea · RECRUITING
• Asan Medical Center, Seoul, South Korea · RECRUITING
• Samsung Medical Center, Seoul, South Korea · RECRUITING
• Clinica Universidad de Navarra, Pamplona, Navarre, Spain · RECRUITING
• Hospital Universitari Vall d'Hebron - VHIO, Barcelona, Spain · RECRUITING
• Hospital Clinic de Barcelona, Barcelona, Spain · RECRUITING
• Hospital Universitario 12 de Octubre, Madrid, Spain · RECRUITING
• Hospital Universitario Virgen del Rocio, Seville, Spain · RECRUITING
• Hospital Clinico Universitario de Valencia, Valencia, Spain · RECRUITING
• University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre, Birmingham, United Kingdom · RECRUITING
• Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom · RECRUITING
• The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital-London, London, United Kingdom · RECRUITING
• Imperial College Healthcare NHS Foundation Trust, Hammersmith Hospital, London, United Kingdom · RECRUITING
• The Christie NHS Foundation Trust, Manchester, United Kingdom · RECRUITING