Tests daraxonrasib alone or with chemotherapy for advanced pancreatic cancer
Tests daraxonrasib, alone or with chemotherapy, in adults with advanced pancreatic cancer.
Plain-language title generated from the registry record
Registry title: Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Key facts
- Where
- Aarhus N, Herlev, and Odense C, DenmarkSee the 3 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which describes how well you can do daily activities?
Source: NCT07491445, who can take part
Where in Denmark
- Region MidtjyllandAarhus N, DenmarkTaking people
- Region HovedstadenHerlev, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Revolution Medicines, Inc.
- Trial code
- NCT07491445EU 2025-525088-34-00
- Record updated
- 2 October 2026
- Original description
The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.Read full original descriptionShow less
RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma
The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.
Inclusion: At least 18 years old and has provided informed consent; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Histologically or cytologically confirmed pancreatic adenocarcinoma; Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent; Documented RAS mutation status, either mutant or wild-type; Measurable disease per RECIST v1.1; Adequate organ function (bone marrow, liver, kidney, coagulation); Able to take oral medications.
Exclusion: Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting; Major surgery within 28 days prior to randomization; Active or known history of untreated central nervous system metastatic disease; Any conditions that may affect the ability to take or absorb study drug; Patient is unable or unwilling to comply with protocol-required study visits or procedures.