An expanded access program has been established to provide daraxonrasib to eligible adult patients with previously treated metastatic pancreatic adenocarcinoma, according to a notice on ClinicalTrials.gov. The program is intended for patients who have no comparable or satisfactory alternative therapy and are unable to participate in an ongoing daraxonrasib clinical trial.
The program aims to provide access to daraxonrasib before the drug reaches potential commercial availability. This initiative is designed to address an unmet medical need and is not intended to support clinical development objectives.
Daraxonrasib is an investigational, orally administered RAS(ON) inhibitor that is administered as monotherapy. Under this program, the sponsor will supply the drug free of charge for the duration of the treatment.
Eligibility for the program requires participants to be at least 18 years old and have provided informed consent. Patients must have a histologically or cytologically confirmed metastatic pancreatic adenocarcinoma and evidence of active disease progression during or following their most recent line of systemic therapy.
Potential participants must have received and progressed on, been intolerant to, or no longer be expected to benefit from standard therapies, including a regimen containing either a fluoropyrimidine-based or gemcitabine-based therapy. Additionally, patients must have adequate bone marrow, renal, hepatic, and coagulation functions and be able to take oral medications.
The study involves 241 locations across the United States. In Utah, participating locations include the Ogden Clinic, Utah Cancer Specialists (UCS), and the Huntsman Cancer Institute & Hospital.
