Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06625320 | RECRUITING | Pancreatic Cancer

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

Revolution Medicines, Inc.

Brief Summary:

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.

Condition or disease

Pancreatic Cancer

PDAC

PDAC - Pancreatic Ductal Adenocarcinoma

Intervention/treatment

RMC-6236

Gemcitabine

nab-paclitaxel

Irinotecan

Liposomal irinotecan

5-fluorouracil

leucovorin

Oxaliplatin

Phase

PHASE3

Detailed Description:

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with RMC-6236 will improve progression free survival (PFS) or overall survival (OS) compared to Investigator's choice of standard of care chemotherapy in patients with metastatic PDAC who were previously treated with one prior line of therapy with 5-fluorouracil (5-FU) based or gemcitabine-based regimen. Patients will be randomized in a 1:1 ratio to receive RMC-6236 (Arm A) or Investigator's choice of standard of care chemotherapy (Arm B).

Study Type : INTERVENTIONAL
Estimated Enrollment : 460 participants
Masking : NONE
Primary Purpose : 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)
Actual Study Start Date : 2024-10-16
Estimated Primary Completion Date : 2026-06
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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.
Exclusion Criteria
  • * 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
Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Location Details

NCT06625320

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

RECRUITING

United States, Arizona

Mayo Clinic

Phoenix, Arizona, United States, 85054

RECRUITING

United States, California

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

RECRUITING

United States, California

UCLA

Los Angeles, California, United States, 90095

RECRUITING

United States, California

UC San Diego Health Moores Cancer Center

San Diego, California, United States, 92037

RECRUITING

United States, California

Mission Hall UCSF

San Francisco, California, United States, 94158

RECRUITING

United States, Colorado

Rocky Mountain Cancer

Aurora, Colorado, United States, 80012

RECRUITING

United States, Florida

Mayo Clinic Cancer Center

Jacksonville, Florida, United States, 32224

RECRUITING

United States, Florida

Cancer Care Centers of Brevard Inc

Palm Bay, Florida, United States, 32909

RECRUITING

United States, Maryland

Johns Hopkins

Baltimore, Maryland, United States, 21287

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Road cancer

Karmanos Cancer Institute

Detroit, Road cancer, United States, 48201

RECRUITING

United States, Minnesota

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

RECRUITING

United States, Missouri

Washington University

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, New York

NYU Lagone Health

New York, New York, United States, 10016

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10022

RECRUITING

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032

RECRUITING

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

RECRUITING

United States, Ohio

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

RECRUITING

United States, Pennsylvania

Abramson Cancer Center Clinical Research Unit

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Tennessee

Sarah Cannon Research Institute (Tennessee)

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Texas Oncology Sammons

Dallas, Texas, United States, 75246

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

Texas Oncology - Central South

Irving, Texas, United States, 75063

RECRUITING

United States, Utah

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

RECRUITING

United States, Virginia

Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031

RECRUITING

France,

Institut Paoli CALMETTES

Marseille, France, 13009

RECRUITING

France,

Centre Eugene Marquis

Rennes, France, 35042

RECRUITING

France,

Hospital Paul Brousse

Marne, France, 94804

RECRUITING

France,

Gustave Roussy

Villejuif, France, 94805

RECRUITING

Italy,

IRCCS Foundation National Cancer Institute

Milan, Italy,

RECRUITING

Italy,

European Ieo-Institute of Oncology

Milan, Italy,

RECRUITING

Italy,

Hospital

Pisa, Italy, 56126

RECRUITING

Japan,

National Cancer Center Hospital

Tokyo, Japan, 104-0045

RECRUITING

Japan,

Cancer Institute Hospital of JFCR

Tokyo, Japan, 135-8550

RECRUITING

Japan,

Kanagawa Cancer Center

Yokohama, Japan, 241-8515

RECRUITING

Puerto Rico,

Pan-American Center for Oncology Trials

San Juan, Puerto Rico, 00907

RECRUITING

Spain,

October 12 hospital

Madrid, Spain, 28041

RECRUITING

Spain,

Clinic University of Navarra

Pamplona, Spain, 31008