- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07573215
Expanded Access Program for Daraxonrasib (RMC-6236) in Previously Treated Metastatic Pancreatic Adenocarcinoma
Expanded Access Program to Treat Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma With Daraxonrasib
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This EAP has been established to provide access to daraxonrasib to patients with previously treated metastatic pancreatic adenocarcinoma during the period before potential commercial availability. Patients may be eligible if they have progressed on, are intolerant of, or are no longer expected to benefit from available standard therapies, and if they are not able to enroll in a clinical trial of daraxonrasib due to ineligibility or lack of access. This EAP is intended to address an unmet medical need and is not designed to support clinical development objectives.
Daraxonrasib is an investigational, orally administered, RAS(ON) inhibitor administered as monotherapy. Daraxonrasib will be supplied by the Sponsor free of charge during the duration of treatment under this program.
Study Type
Expanded Access Type
- Treatment IND/Protocol
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 00909
- Available
- PanOncology Centre
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Alabama
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Daphne, Alabama, United States, 36526
- Available
- Southern Cancer Center
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Mobile, Alabama, United States, 36608
- Available
- Southern Cancer Center
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Alaska
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Anchorage, Alaska, United States, 99508
- Available
- Alaska Oncology and Hematology
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Arizona
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Scottsdale, Arizona, United States, 85258
- Available
- Honor Health
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California
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Chula Vista, California, United States, 91911
- Available
- Care Oncology Center
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Duarte, California, United States, 91010
- Available
- City of Hope Cancer Center (California)
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Los Angeles, California, United States, 90048
- Available
- Cedars-Sinai Medical Center
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Los Angeles, California, United States, 90095
- Available
- University of California
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Los Angeles, California, United States, 90033
- Available
- USC Norris Comprehensive Cancer Hospital
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Los Angeles, California, United States, 90095
- Available
- UCLA Health Westlake Village
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Mountain View, California, United States, 94040
- Available
- El Camino Health
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Roseville, California, United States, 95661
- Available
- The Kaiser Permanente Medical Group
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Sacramento, California, United States, 95816
- Available
- Sutter Health
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San Francisco, California, United States, 94115
- Available
- Sutter Health
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Vacaville, California, United States, 95687
- Available
- NorthBay Health Heidi Y Campini Cancer Center
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Walnut Creek, California, United States, 94598
- Available
- UCSF John Muir Health
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Colorado
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Aurora, Colorado, United States, 80012
- Available
- Rocky Mountain Cancer Center
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Durango, Colorado, United States, 81301
- Available
- CommonSpirit Oncology Mercy
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Florida
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Boca Raton, Florida, United States, 33487
- Available
- Lynn Cancer Institute - Boca Raton Regional Hospital
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Hollywood, Florida, United States, 33021
- Available
- Memorial Cancer Institute
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Jacksonville, Florida, United States, 32224
- Available
- Mayo Clinic - Florida
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Miami, Florida, United States, 33176
- Available
- Baptist Hospital of Miami
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Miami, Florida, United States, 33136
- Available
- Sylvester Comprehensive Cancer Center
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Miami Beach, Florida, United States, 33140
- Available
- Mount Sinai Medical Center of Florida
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Tampa, Florida, United States, 33612
- Available
- Moffitt Cancer Center
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Hawaii
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Honolulu, Hawaii, United States, 96813
- Available
- The Queen's Medical Center
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Illinois
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Arlington Heights, Illinois, United States, 60005
- Available
- Illinois Cancer Specialist
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Iowa
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Waukee, Iowa, United States, 50263
- Available
- University of Iowa
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Kansas
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Merriam, Kansas, United States, 66204
- Available
- Advent Health Shawnee Mission
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Westwood, Kansas, United States, 66205
- Available
- University of Kansas Medical Center
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Wichita, Kansas, United States, 67214
- Available
- Cancer Center of Kansas
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Kentucky
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Lexington, Kentucky, United States, 40503
- Available
- Baptist Health Lexington
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Available
- LSU LCMC Health Cancer Center
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Maine
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Topsham, Maine, United States, 04086
- Available
- New England Cancer Specialists
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Maryland
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Baltimore, Maryland, United States, 21231
- Available
- Johns Hopkins
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Available
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02215
- Available
- Dana Farber Cancer Institute
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Available
- University of Michigan
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Detroit, Michigan, United States, 48201
- Available
- Karmanos Cancer Institute (Barbara Ann Karmanos Cancer Hospital)
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Detroit, Michigan, United States, 48202
- Available
- Henry Ford Health
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Minnesota
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Rochester, Minnesota, United States, 55905
- Available
- Mayo Clinic Minnesota
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Saint Louis Park, Minnesota, United States, 55426
- Available
- Park Nicollet Specialty Center
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Saint Paul, Minnesota, United States, 55101
- Available
- Health Partners Oncology
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Missouri
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Kansas City, Missouri, United States, 64111
- Available
- Saint Luke's Hospital of Kansas City
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Kansas City, Missouri, United States, 64132
- Available
- Mid America Cancer Care
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St Louis, Missouri, United States, 63141
- Available
- Washington University School of Medicine
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Nebraska
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Omaha, Nebraska, United States, 68130
- Available
- Nebraska Cancer Specialists
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New Jersey
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Morristown, New Jersey, United States, 07960
- Available
- Overlook Medical Center - Medical Diagnostic Associates - Atlantic Medical Group
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New York
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Brooklyn, New York, United States, 11206
- Available
- Hirschfeld Oncology
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Long Island City, New York, United States, 11101
- Available
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10016
- Available
- NYU Langone Health
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New York, New York, United States, 10029
- Available
- The Mount Sinai Hospital
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The Bronx, New York, United States, 10461
- Available
- Montefiore Medical Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Available
- Duke Cancer Institute
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Huntersville, North Carolina, United States, 28078
- Available
- Carolina BioOncology Institute
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Ohio
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Columbus, Ohio, United States, 43219
- Available
- Zangmeister Cancer Center
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Dayton, Ohio, United States, 45459
- Available
- Premier Health OH
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Middletown, Ohio, United States, 45005
- Available
- Premier Health OH
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73120
- Available
- Mercy Hospital Oklahoma City
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Oregon
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Salem, Oregon, United States, 97301
- Available
- Oregon Oncology Specialists
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Pennsylvania
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Dunmore, Pennsylvania, United States, 18512
- Available
- Hematology & Oncology Associates of NEPA
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Philadelphia, Pennsylvania, United States, 19107
- Available
- Thomas Jefferson University Hospital
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Sayre, Pennsylvania, United States, 18840
- Available
- Guthrie Sayre
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Available
- Avera Cancer Institute
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Tennessee
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Germantown, Tennessee, United States, 38138
- Available
- West Cancer Center
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Nashville, Tennessee, United States, 37203
- Available
- Sarah Cannon Cancer Institute
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Texas
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Houston, Texas, United States, 77030
- Available
- MD Anderson Cancer Center
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Washington
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Renton, Washington, United States, 98057
- Available
- Seattle Integrative Cancer Center
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Seattle, Washington, United States, 98101
- Available
- Virginia Mason Medical Center
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Seattle, Washington, United States, 98104
- Available
- Swedish Cancer Institute Treatment Center
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Available
- Marshfield Medical Center
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Milwaukee, Wisconsin, United States, 53226
- Available
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
- Evidence of active disease progression during or following the most recent line of systemic therapy for PDAC, based on investigator assessment.
- At least one prior line of systemic therapy in the metastatic setting, which must include either a fluoropyrimidine-based or gemcitabine-based regimen.
- Received and progressed, been intolerant to prior standard therapy, or no longer expected to benefit from standard therapies.
- Adequate bone marrow, renal, hepatic, and coagulation functions.
- Ineligible for, or unable to enroll in, another clinical trial of daraxonrasib, if available.
- Able to take oral medications
Exclusion Criteria:
- History of known central nervous system metastatic disease.
- Concurrent systemic anticancer therapy.
- Significant cardiovascular disease.
- Major GI conditions that may affect the ability to take or absorb daraxonrasib (patients with prior Whipple procedure are eligible).
- Active uncontrolled systemic infection.
- Major surgery within 28 days before enrollment.
- Additional inclusion and exclusion criteria may apply.
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Compassionate Use
- Pancreatic cancer
- KRAS
- Pancreatic Adenocarcinoma
- RAS
- Pancreatic ductal adenocarcinoma (PDAC)
- Pancreatic Adenocarcinoma Metastatic
- EAP
- Metastatic pancreatic adenocarcinoma
- RMC-6236
- Pancreatic Cancer Metastatic
- Daraxonrasib
- Pancreatic Adenosquamous Carcinoma
- Expanded Access Program (EAP)
- RMC-0706236
- RAS(ON) inhibitor
- Unmet medical need
Additional Relevant MeSH Terms
Other Study ID Numbers
- RMC-6236-401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Revolution Medicines, Inc.RecruitingPancreatic Cancer | Pancreatic Adenocarcinoma | NSCLC | Advanced Solid Tumors | Non-small Cell Lung Cancer (NSCLC) | CRC | Pancreatic Ductal Adenocarcinoma (PDAC) | PDAC | Colorectal Cancer (CRC) | Lung Cancer (NSCLC)United States
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