Expanded Access Program for Daraxonrasib (RMC-6236) in Previously Treated Metastatic Pancreatic Adenocarcinoma

Summary

This Expanded Access Program (EAP) is intended to provide daraxonrasib to eligible adult patients with previously treated metastatic pancreatic adenocarcinoma, who have no comparable or satisfactory alternative therapy and are unable to participate in an ongoing daraxonrasib clinical trial.

Interventions

• daraxonrasib · DRUG

  Oral tablets administered once daily

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (257)

• Alabama Oncology, Birmingham, Alabama · AVAILABLE
• Southern Cancer Center, Daphne, Alabama · AVAILABLE
• Dothan Hematology and Oncology, Dothan, Alabama · AVAILABLE
• Alabama Cancer Care of Ft Payne, Fort Payne, Alabama · AVAILABLE
• USA Health Mitchell Cancer Institute, Mobile, Alabama · AVAILABLE
• Southern Cancer Center, Mobile, Alabama · AVAILABLE
• Montgomery Cancer Center, Montgomery, Alabama · AVAILABLE
• Alabama Cancer Care of Tuscaloosa, Tuscaloosa, Alabama · AVAILABLE
• Alaska Oncology and Hematology, Anchorage, Alaska · AVAILABLE
• Cancer and Blood Specialists of Arizona, Casa Grande, Arizona · AVAILABLE
• City of Hope Phoenix, Goodyear, Arizona · AVAILABLE
• Mayo Clinic - Arizona, Phoenix, Arizona · AVAILABLE
• Honor Health, Scottsdale, Arizona · AVAILABLE
• University of Arizona Cancer Center, Tucson, Arizona · AVAILABLE
• Mercy Hospital Fort Smith, Fort Smith, Arkansas · AVAILABLE
• Genesis Cancer and Blood Institute, Hot Springs, Arkansas · AVAILABLE
• Carti Cancer Center, Little Rock, Arkansas · AVAILABLE
• Care Oncology Center, Chula Vista, California · AVAILABLE
• City of Hope Cancer Center (California), Duarte, California · AVAILABLE
• Cancer and Blood Specialty Clinics, Fountain Valley, California · AVAILABLE
• California Cancer Associates for Research and Excellence, Fresno, California · AVAILABLE
• Providence St. Jude, Fullerton, California · AVAILABLE
• Marin Cancer Care, Greenbrae, California · AVAILABLE
• USC Norris Comprehensive Cancer Hospital, Los Angeles, California · AVAILABLE
• Cedars-Sinai Medical Center, Los Angeles, California · AVAILABLE
• UCLA Health Westlake Village, Los Angeles, California · AVAILABLE
• University of California, Los Angeles, California · AVAILABLE
• Pacific Cancer Care, Monterey, California · AVAILABLE
• El Camino Health, Mountain View, California · AVAILABLE
• University of California - San Francisco, Oakland, California · AVAILABLE
• UCI Health, Orange, California · AVAILABLE
• Desert Care Network Comprehensive Cancer, Palm Springs, California · AVAILABLE
• The Kaiser Permanente Medical Group, Roseville, California · AVAILABLE
• Sutter Health, Sacramento, California · AVAILABLE
• Scripps Clinic Torrey Pines, San Diego, California · AVAILABLE
• Sutter Health, San Francisco, California · AVAILABLE
• Bakar Precision Cancer Medicine Building, San Francisco, California · AVAILABLE
• CommonSpirit, San Luis Obispo, California · AVAILABLE
• Providence Medical Foundation, Santa Rosa, California · AVAILABLE
• Stanford University, Stanford, California · AVAILABLE
• NorthBay Health Heidi Y Campini Cancer Center, Vacaville, California · AVAILABLE
• UCSF John Muir Health, Walnut Creek, California · AVAILABLE
• Rocky Mountain Cancer Center, Aurora, Colorado · AVAILABLE
• UC Health Memorial Health System, Colorado Springs, Colorado · AVAILABLE
• AdventHealth Porter, Denver, Colorado · AVAILABLE
• Intermountain Health, Denver, Colorado · AVAILABLE
• CommonSpirit Oncology Mercy, Durango, Colorado · AVAILABLE
• UCHealth Poudre Valley Hospital, Fort Collins, Colorado · AVAILABLE
• Yale New Haven Hospital, New Haven, Connecticut · AVAILABLE
• Norwalk Hospital, Norwalk, Connecticut · AVAILABLE
• Eastern Connecticut Hematology and Oncology, Norwich, Connecticut · AVAILABLE
• Lynn Cancer Institute - Boca Raton Regional Hospital, Boca Raton, Florida · AVAILABLE
• Advanced Cancer Treatment Centers, Brooksville, Florida · AVAILABLE
• Memorial Cancer Institute, Hollywood, Florida · AVAILABLE
• Mayo Clinic - Florida, Jacksonville, Florida · AVAILABLE
• Cancer Specialists of North Florida, Jacksonville, Florida · AVAILABLE
• Sylvester Comprehensive Cancer Center, Miami, Florida · AVAILABLE
• Baptist Hospital of Miami, Miami, Florida · AVAILABLE
• Mount Sinai Medical Center of Florida, Miami Beach, Florida · AVAILABLE
• Florida Cancer Specialists and Research Institute, Naples, Florida · AVAILABLE
• Advent Health, Orlando, Florida · AVAILABLE
• Holy Cross Health - Phil Smith Neuroscience Institute ALS Multidisciplinary Clinic, Orlando, Florida · AVAILABLE
• Ascension Sacred Heart, Pensacola, Florida · AVAILABLE
• Intercoastal Medical Group, Sarasota, Florida · AVAILABLE
• Tampa General Hospital, Tampa, Florida · AVAILABLE
• Moffitt Cancer Center, Tampa, Florida · AVAILABLE
• Piedmont Cancer Institute - Atlanta, Atlanta, Georgia · AVAILABLE
• Piedmont Physicians Medical Oncology, Atlanta, Georgia · AVAILABLE
• Emory University Hospital, Atlanta, Georgia · AVAILABLE
• North Side Hospital - Atlanta Cancer Care, Atlanta, Georgia · AVAILABLE
• Piedmont Columbus Regional Midtown, Columbus, Georgia · AVAILABLE
• Central Georgia Cancer Care, Macon, Georgia · AVAILABLE
• Northwest Georgia Oncology Centers, Marietta, Georgia · AVAILABLE
• The Queen's Medical Center, Honolulu, Hawaii · AVAILABLE
• Hawai'i Pacific Health, Honolulu, Hawaii · AVAILABLE
• St Luke's Cancer Institute, Boise, Idaho · AVAILABLE
• Beacon Clinic, Post Falls, Idaho · AVAILABLE
• Illinois Cancer Specialist, Arlington Heights, Illinois · AVAILABLE
• Northwestern University, Chicago, Illinois · AVAILABLE
• University of Chicago Medical Center, Chicago, Illinois · AVAILABLE
• Advocate Health Care, Downers Grove, Illinois · AVAILABLE
• Endeavor Health Cancer Institute, Naperville, Illinois · AVAILABLE
• Illinois CancerCare, Peoria, Illinois · AVAILABLE
• OSF Cancer Institute, Peoria, Illinois · AVAILABLE
• Blessing Hospital, Quincy, Illinois · AVAILABLE
• Northwest Oncology & Hematology, Rolling Meadows, Illinois · AVAILABLE
• City of Hope Chicago, Zion, Illinois · AVAILABLE
• Parkview Packnett Family Cancer Institute, Fort Wayne, Indiana · AVAILABLE
• Indiana University School of Medicine, Indianapolis, Indiana · AVAILABLE
• Franciscan Alliance Health, Indianapolis, Indiana · AVAILABLE
• Ascension Medical Group St. Vincent, Newburgh, Indiana · AVAILABLE
• Deaconess Health System, Newburgh, Indiana · AVAILABLE
• McFarland Clinic, Ames, Iowa · AVAILABLE
• University of Iowa Cancer Services Quad Cities, Bettendorf, Iowa · AVAILABLE
• Mercy Medical Center, Cedar Rapids, Iowa · AVAILABLE
• University of Iowa, Waukee, Iowa · AVAILABLE
• Advent Health Shawnee Mission, Merriam, Kansas · AVAILABLE
• University of Kansas Medical Center, Westwood, Kansas · AVAILABLE
• Cancer Center of Kansas, Wichita, Kansas · AVAILABLE
• St. Elizabeth Healthcare, Edgewood, Kentucky · AVAILABLE
• Baptist Health Lexington, Lexington, Kentucky · AVAILABLE
• Norton Cancer Institute, Louisville, Kentucky · AVAILABLE
• Owensboro Health Mitchell Memorial Cancer Center, Owensboro, Kentucky · AVAILABLE
• Mercy Health - Paducah Cancer Center, Paducah, Kentucky · AVAILABLE
• LSU LCMC Health Cancer Center, New Orleans, Louisiana · AVAILABLE
• Ochsner Health System, New Orleans, Louisiana · AVAILABLE
• Willis Knighton Cancer Center, Shreveport, Louisiana · AVAILABLE
• New England Cancer Specialists, Topsham, Maine · AVAILABLE
• Johns Hopkins, Baltimore, Maryland · AVAILABLE
• Frederick Health, Frederick, Maryland · AVAILABLE
• Massachusetts General Hospital, Boston, Massachusetts · AVAILABLE
• Beth Israel Deaconess Medical Center, Boston, Massachusetts · AVAILABLE
• Dana Farber Cancer Institute, Boston, Massachusetts · AVAILABLE
• Lahey Clinic, Burlington, Massachusetts · AVAILABLE
• Mountain Health Clinic, Natick, Massachusetts · AVAILABLE
• UMass Memorial Medical Center, Worcester, Massachusetts · AVAILABLE
• University of Michigan, Ann Arbor, Michigan · AVAILABLE
• Karmanos Cancer Institute (Barbara Ann Karmanos Cancer Hospital), Detroit, Michigan · AVAILABLE
• Henry Ford Health, Detroit, Michigan · AVAILABLE
• The Cancer & Hematology Centers, Grand Rapids, Michigan · AVAILABLE
• Hematology Oncology Consultants, Royal Oak, Michigan · AVAILABLE
• Covenant HealthCare, Saginaw, Michigan · AVAILABLE
• Trinity Health Hospital, Ypsilanti, Michigan · AVAILABLE
• Essentia Health, Duluth, Minnesota · AVAILABLE
• USOR: Minnesota Oncology Hematology, PA, Edina, Minnesota · AVAILABLE
• Mayo Clinic Minnesota, Rochester, Minnesota · AVAILABLE
• Health Partners Frauenshuh Cancer Center, Saint Louis Park, Minnesota · AVAILABLE
• HealthPartners Frauenshuh Cancer Center, Saint Louis Park, Minnesota · AVAILABLE
• Park Nicollet Specialty Center, Saint Louis Park, Minnesota · AVAILABLE
• Health Partners Oncology, Saint Paul, Minnesota · AVAILABLE
• Jackson Oncology Associates, Jackson, Mississippi · AVAILABLE
• University Hospital - MU Health Care, Columbia, Missouri · AVAILABLE
• Mercy Hospital Joplin, Joplin, Missouri · AVAILABLE
• Saint Luke's Hospital of Kansas City, Kansas City, Missouri · AVAILABLE
• Mid America Cancer Care, Kansas City, Missouri · AVAILABLE
• Mercy Hospital Springfield, Springfield, Missouri · AVAILABLE
• Oncology Hematology Associates, Springfield, Missouri · AVAILABLE
• Mercy Hospital St. Louis-South, St Louis, Missouri · AVAILABLE
• Pratt Cancer Center, St Louis, Missouri · AVAILABLE
• Washington University School of Medicine, St Louis, Missouri · AVAILABLE
• Logan Health, Kalispell, Montana · AVAILABLE
• NHO Revive Research Institute, Lincoln, Nebraska · AVAILABLE
• University of Nebraska Medical Center, Omaha, Nebraska · AVAILABLE
• Nebraska Cancer Specialists, Omaha, Nebraska · AVAILABLE
• Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire · AVAILABLE
• MD Anderson at Cooper, Camden, New Jersey · AVAILABLE
• Summit Health, Florham Park, New Jersey · AVAILABLE
• Lindenberg Cancer & Hematology Center, Marlton, New Jersey · AVAILABLE
• Overlook Medical Center - Medical Diagnostic Associates - Atlantic Medical Group, Morristown, New Jersey · AVAILABLE
• Rutgers Cancer Institute, New Brunswick, New Jersey · AVAILABLE
• Community Medical Center, Toms River, New Jersey · AVAILABLE
• New York Oncology Hematology, Albany, New York · AVAILABLE
• Hirschfeld Oncology, Brooklyn, New York · AVAILABLE
• Dosik Hematology and Oncology, Brooklyn, New York · AVAILABLE
• Northwell Health, Lake Success, New York · AVAILABLE
• Memorial Sloan Kettering Cancer Center, Long Island City, New York · AVAILABLE
• NYU Langone Health, New York, New York · AVAILABLE
• Columbia University, New York, New York · AVAILABLE
• The Mount Sinai Hospital, New York, New York · AVAILABLE
• Columbia University Irving Medical Center, New York, New York · AVAILABLE
• New York Cancer and Blood Specialists, New York, New York · AVAILABLE
• Rochester Regional Health, Rochester, New York · AVAILABLE
• Stony Brook University Hospital, Stony Brook, New York · AVAILABLE
• Montefiore Medical Center, The Bronx, New York · AVAILABLE
• Atrium Health, Charlotte, North Carolina · AVAILABLE
• Duke Cancer Institute, Durham, North Carolina · AVAILABLE
• Carolina BioOncology Institute, Huntersville, North Carolina · AVAILABLE
• Wake Forest University Health Sciences, Winston-Salem, North Carolina · AVAILABLE
• Sanford Roger Maris Cancer Center, Fargo, North Dakota · AVAILABLE
• Blood and Cancer Center, Canfield, Ohio · AVAILABLE
• Aultman Hospital, Canton, Ohio · AVAILABLE
• OHC (Oncology Hematology Care), Cincinnati, Ohio · AVAILABLE
• UH Seidman Cancer Centre, Cleveland, Ohio · AVAILABLE
• University Hospitals Cleveland Medical Center, Cleveland, Ohio · AVAILABLE
• Cleveland Clinic Foundation, Cleveland, Ohio · AVAILABLE
• Jasonway Cancer Center, Columbus, Ohio · AVAILABLE
• Ohio Health, Columbus, Ohio · AVAILABLE
• OhioHealth Mansfield Hospital, Columbus, Ohio · AVAILABLE
• Zangmeister Cancer Center, Columbus, Ohio · AVAILABLE
• The Ohio State University Wexner Medical Center, Columbus, Ohio · AVAILABLE
• Premier Health OH, Dayton, Ohio · AVAILABLE
• Kettering Health Cancer Center, Kettering, Ohio · AVAILABLE
• Premier Health OH, Middletown, Ohio · AVAILABLE
• OU Health Science Center - Stephenson Cancer Center, Oklahoma City, Oklahoma · AVAILABLE
• Mercy Hospital Oklahoma City, Oklahoma City, Oklahoma · AVAILABLE
• Samaritan Hemotology and Oncology, Corvallis, Oregon · AVAILABLE
• Compass Oncology, Happy Valley, Oregon · AVAILABLE
• Providence Medical Center, Portland, Oregon · AVAILABLE
• Oregon Oncology Specialists, Salem, Oregon · AVAILABLE
• Willamette Valley Cancer Institute, Springfield, Oregon · AVAILABLE
• Lehigh Valley Hospital, Allentown, Pennsylvania · AVAILABLE
• St. Luke's University Health Network, Bethlehem, Pennsylvania · AVAILABLE
• Bryn Mawr Hospital, Bryn Mawr, Pennsylvania · AVAILABLE
• Allegheny Health Network Cancer Institute, Butler, Pennsylvania · AVAILABLE
• Hematology & Oncology Associates of NEPA, Dunmore, Pennsylvania · AVAILABLE
• Alliance Cancer Specialists, Media, Pennsylvania · AVAILABLE
• Allegheny Valley Hospital, Natrona Heights, Pennsylvania · AVAILABLE
• Paoli Hospital, Paoli, Pennsylvania · AVAILABLE
• University of Pennsylvania, Philadelphia, Pennsylvania · AVAILABLE
• Thomas Jefferson University Hospital, Philadelphia, Pennsylvania · AVAILABLE
• Fox Chase Cancer Center, Philadelphia, Pennsylvania · AVAILABLE
• University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania · AVAILABLE
• UPMC Western Maryland, Pittsburgh, Pennsylvania · AVAILABLE
• Guthrie Sayre, Sayre, Pennsylvania · AVAILABLE
• UPMC Hillman Cancer Center, West Mifflin, Pennsylvania · AVAILABLE
• Lankenau Medical Center, Wynnewood, Pennsylvania · AVAILABLE
• Rhode Island Hospital, Providence, Rhode Island · AVAILABLE
• Bon Secours St. Francis Cancer Center, Charleston, South Carolina · AVAILABLE
• McLeod Health, Florence, South Carolina · AVAILABLE
• Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute, Greer, South Carolina · AVAILABLE
• Monument Health Cancer Care Institute, Rapid City, South Dakota · AVAILABLE
• Sanford Health, Sioux Falls, South Dakota · AVAILABLE
• Avera Cancer Institute, Sioux Falls, South Dakota · AVAILABLE
• West Cancer Center, Germantown, Tennessee · AVAILABLE
• Tennessee Cancer Specialists, Knoxville, Tennessee · AVAILABLE
• Baptist Cancer Center, Memphis, Tennessee · AVAILABLE
• Sarah Cannon Cancer Institute, Nashville, Tennessee · AVAILABLE
• Tennessee Oncology, Nashville, Tennessee · AVAILABLE
• University of Texas Southwestern Medical, Dallas, Texas · AVAILABLE
• DHR Health, Edinburg, Texas · AVAILABLE
• William Beaumont Army Medical Center - Fort Bliss, Fort Bliss, Texas · AVAILABLE
• American Oncology Network - Oncology Consultants, Houston, Texas · AVAILABLE
• Houston Methodist Hospital- Cancer Center, Houston, Texas · AVAILABLE
• MD Anderson Cancer Center, Houston, Texas · AVAILABLE
• Covenant Health - Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas · AVAILABLE
• Texas Oncology, Pearland, Texas · AVAILABLE
• Methodist Richardson Cancer Center, Richardson, Texas · AVAILABLE
• UT Health San Antonio MD Anderson Cancer Center, San Antonio, Texas · AVAILABLE
• Baylor Scott & White Health, Temple, Texas · AVAILABLE
• Ogden Clinic, Ogden, Utah · AVAILABLE
• Utah Cancer Specialists (UCS), Salt Lake City, Utah · AVAILABLE
• Huntsman Cancer Institute & Hospital, Salt Lake City, Utah · AVAILABLE
• University of Vermont Medical Center, Burlington, Vermont · AVAILABLE
• Inova Schar Cancer, Fairfax, Virginia · AVAILABLE
• Virginia Cancer Specialists, Fairfax, Virginia · AVAILABLE
• Hematology Oncology Associates of Fredericksburg, Fredericksburg, Virginia · AVAILABLE
• Virginia Oncology Associates, Hampton, Virginia · AVAILABLE
• Riverside Health, Newport News, Virginia · AVAILABLE
• VCU Health, Richmond, Virginia · AVAILABLE
• Virginia Cancer Institute, Richmond, Virginia · AVAILABLE
• Kadlec Regional Medical Center, Kennewick, Washington · AVAILABLE
• Seattle Integrative Cancer Center, Renton, Washington · AVAILABLE
• Virginia Mason Medical Center, Seattle, Washington · AVAILABLE
• Providence Swedish Cancer Institute, Seattle, Washington · AVAILABLE
• Swedish Cancer Institute Treatment Center, Seattle, Washington · AVAILABLE
• Fred Hutch Cancer Center, Seattle, Washington · AVAILABLE
• Providence St. Mary Medical Center, Walla Walla, Washington · AVAILABLE
• ThedaCare Regional Cancer Center, Appleton, Wisconsin · AVAILABLE
• Aurora Medical Center, Grafton, Wisconsin · AVAILABLE
• HSHS St. Mary's Hospital Medical Center, Green Bay, Wisconsin · AVAILABLE
• Bellin Health, Green Bay, Wisconsin · AVAILABLE
• Emplify Health by Gundersen, La Crosse, Wisconsin · AVAILABLE
• University of Wisconsin, Madison, Wisconsin · AVAILABLE
• Marshfield Medical Center, Marshfield, Wisconsin · AVAILABLE
• Medical College of Wisconsin, Milwaukee, Wisconsin · AVAILABLE
• UW Health Cancer Center at ProHealth Care, Waukesha, Wisconsin · AVAILABLE
• PanOncology Centre, San Juan, Puerto Rico · AVAILABLE