ACTIVE_NOT_RECRUITING

Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

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Conditions

Pancreatic CancerPDACPDAC - Pancreatic Ductal AdenocarcinomaPancreatic Ductal AdenocarcinomaRASKRASNRASHRASRAS Wild-TypeRAS Q61 MutationRAS G12 MutationRAS G13 Mutation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of Daraxonrasib (RMC-6236) Versus Investigator's Choice of Standard of Care Therapy in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Quick Facts

Study Start:2024-10-16
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06625320

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years old and has provided informed consent.
  2. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  3. * Histologically or cytologically confirmed PDAC with metastatic disease.
  4. * Measurable disease per RECIST 1.1.
  5. * Adequate organ function (bone marrow, liver, kidney, coagulation)
  6. * Documented RAS mutation status, either mutant or wild-type. RAS mutations defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
  7. * Able to take oral medications.
  1. * Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
  2. * History of or known central nervous system metastatic disease.
  3. * Any conditions that may affect the ability to take or absorb study treatment
  4. * Major surgery within 4 weeks prior to randomization.
  5. * Patient is unable or unwilling to comply with protocol-required study visits or procedures

Contacts and Locations

Principal Investigator

Study Director
STUDY_DIRECTOR
Revolution Medicines

Study Locations (Sites)

Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
Mayo Clinic Cancer Center - Phoenix
Phoenix, Arizona, 85054
United States
City of Hope-Duarte
Duarte, California, 91010
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
UCLA
Los Angeles, California, 90095
United States
UC San Diego Health Moores Cancer Center
San Diego, California, 92037
United States
Mission Hall UCSF
San Francisco, California, 94158
United States
Rocky Mountain Cancer
Aurora, Colorado, 80012
United States
Mayo Clinic Cancer Center - Florida
Jacksonville, Florida, 32224
United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
Cancer Care Centers of Brevard Inc
Palm Bay, Florida, 32909
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
The Queen's Medical Center
Honolulu, Hawaii, 96813
United States
The University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Johns Hopkins
Baltimore, Maryland, 21287
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Mayo Clinic Cancer Center - Rochester
Rochester, Minnesota, 55905
United States
Washington University
St Louis, Missouri, 63110
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
NYU Lagone Health
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
United States
Columbia University Medical Center
New York, New York, 10032
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Abramson Cancer Center Clinical Research Unit
Philadelphia, Pennsylvania, 19104
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Sarah Cannon Research Institute (Tennessee)
Nashville, Tennessee, 37203
United States
Texas Oncology Sammons
Dallas, Texas, 75246
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Texas Oncology - Central South
Irving, Texas, 75063
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Revolution Medicines, Inc.

  • Study Director, STUDY_DIRECTOR, Revolution Medicines

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 Registration Dates

Study Start Date2024-10-16
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-10-16
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Pancreatic Cancer
  • PDAC
  • Pancreatic Ductal Adenocarcinoma
  • RAS
  • KRAS
  • NRAS
  • HRAS
  • RAS Wild-Type
  • RAS Q61 Mutation
  • RAS G12 Mutation
  • RAS G13 Mutation

Additional Relevant MeSH Terms

  • Pancreatic Cancer
  • PDAC
  • PDAC - Pancreatic Ductal Adenocarcinoma