Taking people in SpainPhase 3
Tests daraxonrasib alone or with chemotherapy for advanced pancreatic cancer
Tests daraxonrasib, alone or with chemotherapy, in adults with advanced pancreatic cancer.
Key facts
- Who runs it
- Revolution Medicines, Inc.
- Where
- Barcelona, Córdoba, L'Hospitalet de Llobregat, Madrid, Pamplona, Valencia, and Zaragoza, SpainSee the 11 sitesAlso in 20 other countries, 126 sites
- Trial code
- Registry title
- Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 900 people, planned
- Started
- 9 Mar 2026
- Expected to end
- Mar 2029
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- daraxonrasib
- gemcitabine
- nab-paclitaxel
- Record updated
- 2 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with pancreatic adenocarcinoma that has spread (metastatic) and who have not yet had treatment for the spread. It tests daraxonrasib alone or with chemotherapy against chemotherapy alone.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Pancreatic adenocarcinoma confirmed by tissue or cell tests. Metastatic disease diagnosed 6 weeks or less before consent. Measurable disease per RECIST v1.1. ECOG performance status of 0 or 1.
- Earlier treatment
- No earlier systemic anticancer therapy for metastatic disease. No earlier RAS-targeted therapy in any setting.
- Biomarker or test result
- RAS mutation status must be documented, either mutant or wild-type.
Main reasons for not taking part
- Earlier systemic anticancer therapy for metastatic disease
- Earlier RAS-targeted therapy
- Active or known untreated cancer spread to the brain or spinal cord
- Conditions that affect taking or absorbing the study drug
- Major surgery within 28 days before randomization
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Spain
Also in 20 other countries, 126 sites
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Universitario Reina SofiaCórdoba, SpainTaking people
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpainTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Universitario La PazMadrid, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Clínica Universidad de navarraPamplona, SpainTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpainTaking people
- Hospital Universitario Miguel ServetZaragoza, SpainTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Arm A: daraxonrasibTreatment being tested
study drug
Treatment: daraxonrasib
- Arm B: daraxonrasib + gemcitabine and nab-paclitaxelTreatment being tested
study drug in combination with chemotherapy
Treatment: daraxonrasib, gemcitabine, and nab-paclitaxel
- Arm C: gemcitabine and nab-paclitaxelExisting treatment, for comparison
SOC chemotherapy
Treatment: gemcitabine and nab-paclitaxel
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Tests daraxonrasib alone or with chemotherapy for advanced pancreatic cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07491445, who can take part
- Record updated
- 2 October 2026