Recruiting NCT07252232
Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: daraxonrasib.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma (PDAC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France, Germany, Italy, Japan +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
Detailed description
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve disease-free survival (DFS) compared to SOC observation in patients with resected PDAC who have completed neoadjuvant and/or adjuvant chemotherapy.
Interventions
- Drug daraxonrasib
oral tablets
Primary outcome measures
- Disease-Free Survival (DFS) per Investigator [Time frame: Up to approximately 5 years]
Secondary outcome measures (6)
- Overall survival (OS) [Time frame: Up to approximately 5 years]
- DFS per blinded independent central review (BICR) [Time frame: Up to approximately 5 years]
- DFS Rate at 1 year and 2 years [Time frame: Up to approximately 2 years]
- OS rate at 1 year and 2 years [Time frame: Up to approximately 2 years]
- Safety and tolerability of daraxonrasib [Time frame: Up to approximately 5 years]
- Pharmacokinetics (PK) [Time frame: Up to Cycle 4 Day 1 (Day 85)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 33 centers
- Mayo Clinic — Phoenix
- UC San Diego Moores Cancer Center — La Jolla
- Cedars-Sinai Cancer at Cedars-Sinai Medical Center — Los Angeles
- University of California, Los Angeles — Los Angeles
- Stanford Cancer Institute — Palo Alto
- University of California, San Francisco — San Francisco
- Rocky Mountain Cancer Centers, LLP — Lakewood
- Hartford Healthcare — Hartford
- … and 25 more centers
Italy · 5 centers
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan
- IEO - Instituto Europeo di Oncologia — Milan
- IOV - Istituto Oncologico Veneto IRCCS — Padova
- Azienda Ospedaliero Universitaria Pisana — Pisa
- Centro Ricerche Cliniche di Verona s.r.l. — Verona
United Kingdom · 5 centers
- University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre — Birmingham
- Beatson West of Scotland Cancer Centre — Glasgow
- The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital-London — London
- Imperial College Healthcare NHS Foundation Trust, Hammersmith Hospital — London
- The Christie NHS Foundation Trust — Manchester
Japan · 4 centers
- Kanagawa Cancer Center — Yokohama
- National Cancer Center Hospital East — Chiba
- Kyoto University Hospital — Kyoto
- Cancer Institute Hospital of JFCR — Tokyo
South Korea · 4 centers
- Dong-A University Hospital — Busan
- Seoul National University Hospital — Seoul
- Asan Medical Center — Seoul
- Samsung Medical Center — Seoul
Spain · 4 centers
- Hospital Universitari Vall d'Hebron - VHIO — Barcelona
- Hospital Clinic de Barcelona — Barcelona
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Universitario Virgen del Rocio — Seville
France · 3 centers
- CRLCC Eugene Marquis — Rennes
- Hôpital Paul Brousse — Villejuif
- Institut Gustave Roussy — Villejuif
Germany · 1 center
- Universitaetsklinikum Heidelberg — Heidelberg
Puerto Rico · 1 center
- Pan American Oncology Trials, LLC — San Juan
Identifiers
NCT: NCT07252232 · RMC-6236-304