Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

    Cancer Categories
    • Lung
    Karmanos Trial ID
    • 2019-018
    NCT ID
    • NCT03093116
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II
    Principal Investigator

    Objective:

    Phase 2 Primary Objectives
    • To determine the confirmed ORR as assessed by BICR of repotrectinib in each subject population expansion cohort of solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
    Phase 2 Secondary Objectives
    • To determine the DOR, time to response (TTR), and clinical benefit rate (CBR) of repotrectinib, as assessed by BICR, in each subject population expansion cohort of advanced solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
    • To estimate the PFS and overall survival (OS) of subjects treated with repotrectinib with advanced solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement repotrectinib.
    • To evaluate the safety and tolerability of repotrectinib when administered at the RP2D in subjects with advanced solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
    • To determine the intracranial objective response rate (IC-ORR) of repotrectinib and CNS -PFS in subjects presenting with measurable brain metastases at baseline, using Response Assessment in Neuro-Oncology Brain Metastases modified RECIST v1.1 assessment.
    • To confirm PK of repotrectinib at the RP2D.
    • To assess treatment-related symptoms and general health status using validated instruments of subject- reported outcomes (EORTC-QLQ-C30 and LC-13 when applicable) in subjects treated with repotrectinib.
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266