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  • TRIDENT-1

    Acronym: 

    TRIDENT-1

    ACTRN/NCT /ethics: 

    NCT03093116

    Scientific title: 

    A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

    Summary of trial and patient characteristics

    Cancer Type All cancers
    Trial Type Treatment
    Phase Phase I, Phase II Tumour Stream Solid tumours
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Sex Both Anticipated Start Date 2017-02-27
    Molecular Target Anticipated End Date
    Cancer Type All cancers
    Trial Type Treatment
    Phase Phase I, Phase II
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Solid tumours
    Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Anticipated Start Date 2017-02-27
    Anticipated End Date

    Trial Summary

    Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

    Lay Summary

    A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

    Sponsor / Cooperative group

    Turning Point Therapeutics

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Dr Chris Karapetis Recruiting