Phase 3 study of RMC-6236 in patients with previously treated metastatic PDAC
Key facts
- Where
- Berlin, Heidelberg, Munich és Ulm, NémetországSee the 4 sites
- Phase
- 3. fázis
Where in Németország
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországNo longer taking part
- Universitaetsklinikum Heidelberg AöRHeidelberg, NémetországNo longer taking part
- Klinikum der Universitaet Muenchen AöRMunich, NémetországNo longer taking part
- Universitaetsklinikum Ulm AoRUlm, NémetországNo longer taking part
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
- EU 2024-516063-89-00
- Record updated
- 2026. október 29.
- Original description
In the RAS G-12 population (referred to as RAS G12 population): To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on: PFS OSRead full original descriptionShow less
RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of RMC-6236 versus Investigator’s Choice of Standard of Care Therapy in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
In the RAS G-12 population (referred to as RAS G12 population): To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on: PFS OS
Inclusion: At least 18 years of age and has provided informed consent. Follow local regulatory requirements if the legal age of consent for study participation is >18 years old; ECOG performance status 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); One prior line of systemic therapy in the metastatic setting; Documented RAS mutation status, either mutant or wild-type. RAS mutations are defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61); Able to take oral medications.
Exclusion: Prior therapy with any direct RAS-targeted therapy (eg, degraders and/or inhibitors); Major surgery within 4 weeks prior to randomization; History of or known central nervous system metastatic disease; Any conditions that may affect the ability to take or absorb study treatment; Patient is unable or unwilling to comply with all protocol-required study visits or procedures.