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A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 25, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 26 words Show 4 more changesShow less
    • Secondary endpoints: 10 to 12
    • Site details revised at 14 of 68 sites
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 2 words
  2. Study sites revised (68)v47
  3. Study sites revised (68)v46
  4. Study sites revised (68)v45
  5. Study sites revised (68)v44
Show 42 earlier versionsHide 42 earlier versions
  1. Study sites revised (68)v43
  2. Study sites revised (68)v42
  3. Study sites revised (68)v41
  4. Study sites revised (68)v40
  5. Study sites: 57 to 68v39
  6. Study sites revised (57)v38
  7. Study sites revised (57)v37
  8. Study sites revised (57)v36
  9. Study sites revised (57)v35
  10. Study sites: 54 to 57v34
  11. Eligibility criteria expanded, about 8 words
    • Study description expanded, about 17 words
    v33
  12. Study sites: 50 to 54v32
  13. Site contacts updated at 1 of 50 sitesv31
  14. Site contacts updated at 2 of 50 sitesv30
  15. Primary completion date: Mar 25, 2025 to Sep 30, 2026
    • Study completion date: Mar 25, 2025 to Sep 30, 2027
    • Start date: Mar 20, 2020 to Mar 12, 2020
    • Site details revised at 2 of 50 sites
    v29
  16. Site details revised at 3 of 50 sitesv28
  17. Re-verified, no change to tracked fieldsv27
  18. Site details revised at 4 of 50 sitesv26
  19. Study sites: 28 to 50
    • Primary completion date: Mar 2025 to Mar 25, 2025
    • Study completion date: Sep 2025 to Mar 25, 2025
    v25
  20. Re-verified, no change to tracked fieldsv24
  21. Primary completion date: Dec 2022 to Mar 2025
    • Study completion date: Dec 2023 to Sep 2025
    v23
  22. Study sites: 27 to 28v22
  23. Site details revised at 1 of 27 sitesv21
  24. Re-verified, no change to tracked fieldsv20
  25. Study sites: 26 to 27
    • Eligibility criteria expanded, about 3 words
    v19
  26. Study sites: 24 to 26v18
  27. Study sites: 22 to 24v17
  28. Study sites: 21 to 22v16
  29. Study sites: 18 to 21
    • Eligibility criteria shortened, about 7 words
    • Study description shortened, about 4 words
    v15
  30. Study sites: 15 to 18v14
  31. Study sites: 14 to 15v13
  32. Study sites: 10 to 14v12
  33. Study sites: 9 to 10v11
  34. Study sites: 6 to 9v10
  35. Study description expanded, about 70 wordsv9
  36. Enrollment target: 12 to 75v8 Show 5 more changesShow less
    • Primary endpoints: 2 to 3
    • Start date changed from estimate of Mar 2020 to Mar 20, 2020
    • Eligibility criteria expanded, about 105 words
    • Secondary endpoints: 7 to 10
    • Study description expanded, about 62 words
  37. Study sites: 5 to 6v7
  38. Study sites: 4 to 5
    • Start date: Feb 2020 to Mar 2020
    v6
  39. Start date: Jan 2020 to Feb 2020
    • Site contacts updated at 4 of 4 sites
    v5
  40. Study sites: 3 to 4v4
  41. Study sites: 1 to 3
    • Start date: Dec 2019 to Jan 2020
    v3
  42. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • 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.
Turning Point Therapeutics, Inc.
3 trials monitored
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and 1 more disease
Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D). Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.
Trial Details
NCT Number NCT04094610
Lead Sponsor Turning Point Therapeutics, Inc.
Conditions
(from sponsor)		 Locally Advanced Solid Tumors, Metastatic Solid Tumors, Lymphoma, Primary CNS Tumors
Related terms Glioblastoma, Glioma, Granuloma, Plasma Cell, Lymphoma, Lymphoma, Large-Cell, Anaplastic, Neoplasm Metastasis, Sarcoma, Solitary Fibrous Tumors
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov