RASolute 304: A Phase 3 Multicenter, Open-label, Randomized,2-Arm Study of Adjuvant Daraxonrasib versus Standard of CareObservation Following Completion of Neoadjuvant and/orAdjuvant Chemotherapy in Patients with Resected PancreaticDuctal Adenocarcinoma

Contact:

NCT Number:

Protocol:

ACYY0705

Study Status:

Active/Enrolling

Population:

Adult

Phase:

III

The purpose of this study is to test an experimental drug called Daraxonrasib (RMC-6236) compared to standard of care observation after finishinged chemotherapy given either before surgery to shrink the tumor (neoadjuvant chemotherapy) or after surgery to kill remaining cancer cells in patients with resected PDAC. Daraxonsrasib (RMC-6236) is not approved by the United States Food and Drug Administration (FDA). People who usually have this type of cancer typically receive surgery followed by chemotherapy, and then are monitored without additional treatment. This study is different because it adds an experimental drug after chemotherapy to see if it can improve outcomes. This trial will confirm whether Daraxonrasib is more effective than observation in preventing recurrence after surgery and chemotherapy.

Are you Eligible? (Inclusion Criteria)

  • At least 18 years of age 2. Must have completed their most recent treatment (chemotherapy or radiotherapy or surgery) within the past 12 weeks at the time of randomization 3. Capable of taking oral medications and maintaining a daily medication log.

Specialty Area(s)

Pancreatic Cancer, Immunotherapy

Principal Investigator

Profile Headshot
  • Director of Gastrointestinal Oncology
  • Director of Pancreas Translational Research
  • Co-Director of The Pancreas Center

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032
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