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  • FAST LANE

    Acronym: 

    CodeBreak 100

    ACTRN/NCT /ethics: 

    NCT03600883

    Scientific title: 

    A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreak 100)

    Summary of trial and patient characteristics

    Cancer Type All cancers
    Trial Type Treatment
    Phase Phase I, Phase II Tumour Stream All cancers
    Age Range 18 years and older Cancer Stage Metastatic or Widespread, Locally Recurrent or Locally Advanced
    Sex Both Anticipated Start Date 2018-08-27
    Molecular Target Anticipated End Date 2024-03-08
    Cancer Type All cancers
    Trial Type Treatment
    Phase Phase I, Phase II
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream All cancers
    Cancer Stage Metastatic or Widespread, Locally Recurrent or Locally Advanced
    Anticipated Start Date 2018-08-27
    Anticipated End Date 2024-03-08

    Trial Summary

    Evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.

    Lay Summary

    A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreak 100)

    Sponsor / Cooperative group

    Amgen

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    The Queen Elizabeth Hospital Pamela Cooper pamela.cooper@sa.gov.au 08 8222 6140 Professor Tim Price Recruiting