RECRUITING

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

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 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: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. Eligible 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

Study Contact

Revolution Medicines
CONTACT
1-844-2-REVMED
medinfo@revmed.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Revolution Medicines

Study Locations (Sites)

UCLA
Los Angeles, California, 90095
United States
Johns Hopkins
Baltimore, Maryland, 21287
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
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