Open Actively Recruiting

Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

About

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.

Primary Purpose
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Treatment
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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.
Study Stats
Protocol No.
25-2551
Category
Pancreatic Cancer
Contact
  • Madeleine Manahan
Location
  • UCLA Atascadero
  • UCLA Burbank
  • UCLA Porter Ranch
  • UCLA Santa Barbara
  • UCLA Santa Monica
  • UCLA Westlake Village
For Providers
NCT No.
NCT07252232
For detailed technical eligibility, visit ClinicalTrials.gov.