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

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.

Conditions

Pancreatic Cancer, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Pancreatic Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

UCLA, Los Angeles, California, United States, 90095

Baltimore

Johns Hopkins, Baltimore, Maryland, United States, 21287

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10022

Salt Lake City

Huntsman Cancer Institute, Salt Lake City, Utah, United States, 84112

Fairfax

Virginia Cancer Specialists, Fairfax, Virginia, United States, 22031

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * At least 18 years old and has provided informed consent.
  • * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • * Histologically or cytologically confirmed PDAC with metastatic disease.
  • * Measurable disease per RECIST 1.1.
  • * Adequate organ function (bone marrow, liver, kidney, coagulation)
  • * 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).
  • * Able to take oral medications.
  • * Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
  • * History of or known central nervous system metastatic disease.
  • * Any conditions that may affect the ability to take or absorb study treatment
  • * Major surgery within 4 weeks prior to randomization.
  • * Patient is unable or unwilling to comply with protocol-required study visits or procedures

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Revolution Medicines, Inc.,

Study Director, STUDY_DIRECTOR, Revolution Medicines

Study Record Dates

2027-12