Informations générales (source: ClinicalTrials.gov)
RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of Daraxonrasib (RMC-6236) Versus Investigator's Choice of Standard of Care Therapy in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) (RASolute 302)
Interventional
Phase 3
Revolution Medicines, Inc. (Voir sur ClinicalTrials)
octobre 2024
décembre 2027
22 mai 2025
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON)
inhibitor compared to standard(s) of care (SOC) treatment.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Paul Brousse | Pascal Hammel | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Michel Ducreux | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Eugene Marquis - 35042 - Rennes - France | Julien Edeline | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - 13009 - Marseille - France | Emmanuel Mitry | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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 PDAC with metastatic disease.
- Measurable disease per RECIST 1.1.
- Adequate organ function (bone marrow, liver, kidney, coagulation)
- Documented RAS mutation status, either mutant or wild-type. RAS mutations defined as
nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or
Q61).
- Able to take oral medications.
- 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 PDAC with metastatic disease.
- Measurable disease per RECIST 1.1.
- Adequate organ function (bone marrow, liver, kidney, coagulation)
- Documented RAS mutation status, either mutant or wild-type. RAS mutations defined as
nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or
Q61).
- Able to take oral medications.
- Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
- History of or known central nervous system metastatic disease.
- Any conditions that may affect the ability to take or absorb study treatment
- Major surgery within 4 weeks prior to randomization.
- Patient is unable or unwilling to comply with protocol-required study visits or
procedures