A Phase 3 Multicenter, Open-Label, Randomized,2-Arm Study of Adjuvant Daraxonrasib versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients with Resected Pancreatic Ductal Adenocarcinoma.
Primary Objective:
To compare the effect of treatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC) versus standard of care observation on:
-DFS (per Investigator)
Secondary Objective:
To compare the effect of treatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemotherapy in patients with resected PDAC versus standard of care observation on:
- OS
To compare the effect of treatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemotherapy in patients with resected PDAC versus standard of care observation on:
- DFS (per BICR)
- DFS rate at 1 year and 2 years (per Investigator and BICR)
- OS rate at 1 year and 2 years
To evaluate the safety and tolerability of treatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemotherapy in patients with resected PDAC
To characterize the PK of daraxonrasib
No Drug
- RWJBarnabas Health
- Community Medical Center
- Cooperman Barnabas, Livingston
- Monmouth Medical Center
- Rutgers University
Inclusion Criteria: - At least 18 years old and has provided informed consent. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Histologically confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease. - Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy. - Must have completed most recent treatment within the past 12 weeks. - Adequate organ function (bone marrow, liver, kidney, coagulation). - Documented RAS mutation status. - Able to take oral medications. Exclusion Criteria: - Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors). - Any conditions that may affect the ability to take or absorb study drug. - Major surgery within 28 days prior to randomization. - Patient is unable or unwilling to comply with protocol-required study visits or procedures.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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