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

Study acronym: TRIDENT-1
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 104 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Study sites revised (165)v104
  2. Study sites revised (165)v103
  3. Study sites revised (165)v102
  4. Study sites: 164 to 165v101
  5. Study sites revised (164)v100
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (164)v99
  2. Study sites: 163 to 164v98
  3. Study sites: 158 to 163v97
  4. Study sites: 157 to 158v96
  5. Study sites: 151 to 157v95
  6. Study sites revised (151)v94
  7. Re-verified, no change to tracked fieldsv93
  8. Primary completion date: Jun 30, 2024 to Feb 29, 2028
    • Study completion date: Dec 31, 2024 to Feb 29, 2028
    • Start date: Feb 27, 2017 to Mar 7, 2017
    v92
  9. Site details revised at 2 of 151 sitesv91
  10. Study sites: 176 to 151
    • Primary completion date: Jun 2024 to Jun 30, 2024
    • Study completion date: Dec 2024 to Dec 31, 2024
    v90
  11. Site details revised at 7 of 176 sitesv89
  12. Site details revised at 1 of 176 sitesv88
  13. Re-verified, no change to tracked fieldsv87
  14. Site details revised at 11 of 176 sitesv86
  15. Site contacts updated at 1 of 176 sitesv85
  16. Site contacts updated at 1 of 176 sitesv84
  17. Site details revised at 1 of 176 sitesv83
  18. Primary completion date: Dec 31, 2022 to Jun 2024
    • Study completion date: Jun 2023 to Dec 2024
    • Site contacts updated at 2 of 176 sites
    v82
  19. Site contacts updated at 1 of 176 sitesv81
  20. Site details revised at 1 of 176 sitesv80
  21. Study sites revised (176)v79
  22. Site contacts updated at 2 of 176 sitesv78
  23. Study sites: 175 to 176v77
  24. Site contacts updated at 1 of 175 sitesv76
  25. Site contacts updated at 1 of 175 sitesv75
  26. Site contacts updated at 1 of 175 sitesv74
  27. Study sites: 174 to 175v73
  28. Study sites: 173 to 174v72
  29. Site contacts updated at 3 of 173 sitesv71
  30. Site details revised at 1 of 173 sitesv70
  31. Study sites: 165 to 173v69
  32. Site contacts updated at 1 of 165 sitesv68
  33. Collaborators expanded, about 5 wordsv67
  34. Study sites: 164 to 165v66
  35. Study sites revised (164)v65
  36. Study sites: 163 to 164v64
  37. Site details revised at 1 of 163 sitesv63
  38. Primary completion date: Mar 2021 to Dec 31, 2022
    • Enrollment target: 450 to 500
    • Study sites: 112 to 163
    • Study completion date: Dec 2022 to Jun 2023
    v62
  39. Study sites: 111 to 112v61
  40. Study sites: 110 to 111v60
  41. Study sites: 108 to 110v59
  42. Study sites: 105 to 108v58
  43. Study description shortened, about 22 words
    • Eligibility criteria shortened, about 5 words
    v57
  44. Study sites: 102 to 105v56
  45. Study sites: 100 to 102v55
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 a 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 a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
Trial Details
NCT Number NCT03093116
Lead Sponsor Turning Point Therapeutics, Inc.
Collaborators: Zai Lab (Shanghai) Co., Ltd.
Conditions
(from sponsor)		 Locally Advanced Solid Tumors, Metastatic Solid Tumors
Related terms Adenocarcinoma, Bronchial Neoplasms, Carcinoma, Carcinoma, Bronchogenic, Carcinoma, Neuroendocrine, Carcinoma, Non-Small-Cell Lung, Colonic Diseases, Colonic Neoplasms, Digestive System Neoplasms, Endocrine Gland Neoplasms, Endocrine System Diseases, Gastrointestinal Diseases, Gastrointestinal Neoplasms, Head and Neck Neoplasms, Intestinal Diseases, Intestinal Neoplasms, Lung Diseases, Lung Neoplasms, Neoplasms, Neoplasms by Histologic Type, Neoplasms by Site, Neoplasms, Germ Cell and Embryonal, Neuroectodermal Tumors, Neuroendocrine Tumors, Respiratory Tract Diseases, Respiratory Tract Neoplasms, Sarcoma, Thoracic Neoplasms, Thyroid Diseases, Thyroid Neoplasms
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov