Expanded Access Program For Daraxonrasib (RMC-6236) In Previously Treated Metastatic Pancreatic Adenocarcinoma

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Tanios Bekaii-Saab, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Hani Babiker, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Ryan Carr, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20602496

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