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RASolute 304: 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 (PDAC)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523495-23-00
Enrollment
74
Registered
2026-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resected Pancreatic Ductal Adenocarcinoma (PDAC)

Brief summary

Disease-Free Survival (DFS) per Investigator DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by Investigator.

Detailed description

Overall survival (OS) - OS is defined as the time from randomization until death from any cause, DFS per blinded independent central review (BICR) - DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per RECIST v1.1 as assessed by BICR, DFS Rate at 1 year and 2 years - DFS rate defined as percentage of patients who are disease free at 1 year and 2 years, respectively, OS rate at 1 year and 2 years - OS rate defined as percentage of patients who are alive at 1 year and 2 years, respectively., Safety and tolerability of daraxonrasib - Incidence of adverse events (AEs) and changes from baseline in vital signs, ECOG performance score, and clinical laboratory tests, Pharmacokinetics (PK) - Predose concentration of daraxonrasib

Interventions

Sponsors

Revolution Medicines Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Disease-Free Survival (DFS) per Investigator DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by Investigator.

Secondary

MeasureTime frame
Overall survival (OS) - OS is defined as the time from randomization until death from any cause, DFS per blinded independent central review (BICR) - DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per RECIST v1.1 as assessed by BICR, DFS Rate at 1 year and 2 years - DFS rate defined as percentage of patients who are disease free at 1 year and 2 years, respectively, OS rate at 1 year and 2 years - OS rate defined as percentage of patients who are alive at 1 year and 2 years, respectively., Safety and tolerability of daraxonrasib - Incidence of adverse events (AEs) and changes from baseline in vital signs, ECOG performance score, and clinical laboratory tests, Pharmacokinetics (PK) - Predose concentration of daraxonrasib

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 29, 2026