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

NCT07573215

AvailableN/A

Sponsor: Revolution Medicines, Inc.

Conditions: PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Metastatic Pancreas Adenocarcinoma, Pancreatic Cancer, Pancreatic Cancer Metastatic

Interventions: daraxonrasib

Countries: United States, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Study type: EXPANDED_ACCESS

Eligibility 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.
* 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.
Locations (154)
  • Daphne, Alabama, United States
  • Mobile, Alabama, United States
  • Anchorage, Alaska, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Tucson, Arizona, United States
  • Fort Smith, Arkansas, United States
  • Hot Springs, Arkansas, United States
  • Chula Vista, California, United States
  • Duarte, California, United States
  • Fountain Valley, California, United States
  • Fresno, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Mountain View, California, United States
  • Oakland, California, United States
  • Orange, California, United States
  • Palm Springs, California, United States
  • Roseville, California, United States
  • Sacramento, California, United States
  • San Francisco, California, United States
  • San Luis Obispo, California, United States
  • Stanford, California, United States
  • Vacaville, California, United States
  • Walnut Creek, California, United States
  • Aurora, Colorado, United States
  • Denver, Colorado, United States
  • Denver, Colorado, United States
  • + 124 more on CT.gov