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  • 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)

    Cancer Categories
    • Gastrointestinal (GI)
    Karmanos Trial ID
    • 2024-082
    NCT ID
    • NCT06625320
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase III
    Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
    • Phase III
    Principal Investigator
    • Mohammed Najeeb
      Al Hallak, M.D., MS

      Oncology - Medical View Profile

    Objective:

    Primary Objectives:

    • In the RAS G12-mutant 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

    Secondary Objectives:

    • In the All-Patient population: To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on:
      • PFS
      • OS
    • In the RAS G12 and All-Patient populations: To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on objective response.
    • In the RAS G12 and All-Patient populations: To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on quality of life (QoL), as reported by patients, using EORTC QLQ-PAN26 and EORTC QLQ-C30.
    • In the RAS G12 and All-Patient populations: To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on: − Objective Response (per investigator)
      • DOR
      • TTR
    • In the RAS G12 and All-Patient populations: To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on quality of life (QoL), as reported by patients, using the EORTC QLQ-C30 and EORTC QLQPAN26.
    • In the RAS G12 and All-Patient populations: To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on PFS as assessed by the Investigator.
    • In the RAS G12 and All-Patient populations: To compare the safety and tolerability of RMC-6236 versus Investigator’s choice of standard therapy.
    • In the RAS G12 and All-Patient populations: To characterize the PK of RMC-6236.
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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