Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreati… (NCT06625320) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
United States500 participantsStarted 2024-10-16
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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.
Exclusion Criteria:
* 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
What they're measuring
1
Progression free survival (PFS) in the RAS G12-mutant population
Timeframe: Up to approximately 3 years
2
Overall survival (OS) in the RAS G12-mutant population