EXPANDED ACCESS PROGRAM TO TREAT PATIENTS WITH PREVIOUSLY TREATED METASTATIC PANCREATIC ADENOCARCINOMA WITH DARAXONRASIB

Brief description of study

This Expanded Access Program (EAP) provides eligible patients with metastatic pancreatic adenocarcinoma (pancreatic cancer that has spread to other parts of the body) access to the investigational drug daraxonrasib. The program is intended for patients with a serious or life-threatening disease who have no approved treatment options that are working for them, including those whose cancer has progressed after treatment, who cannot tolerate available therapies, or who cannot receive them for medical reasons. Patients must also be unable to participate in an ongoing clinical trial of daraxonrasib.

The drug is provided free of charge by Revolution Medicines for as long as the patient remains on treatment. If a patient is approved, the drug is supplied in 28-day treatment cycles and may be continued as long as the patient is benefiting and does not experience unacceptable side effects or another reason to stop treatment. Additional supplies require ongoing confirmation that the patient continues to meet the program's eligibility requirements.


Clinical Study Identifier: s26-00693
ClinicalTrials.gov Identifier: NCT07573215
Principal Investigator: Paul E. Oberstein.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Kelly C O'Sullivan, Marta Wioleta Wronska, Abu Ahmed, Shun Yu, Lourdes Gaddi, Monica Rivera, Shushma Upadhayay, Keriann M Scavone, Zefie Kanos, Peter Young Jae Yu, Kenneth Csehak, Allie Nussbaum, Paige Gugerty, Tiffany S Wang, Jennifer Chuy, Anastasiya Apanasyuk, Ilana Zacharia, Manuel Hidalgo Medina, Daniel J Becker, Kristen Spencer, Paola De Leon, Michael Shusterman, Rafael Winograd, Alexander A Hindenburg.


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