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Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

Study acronym: STARTRK-2
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 141 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 130 → 120 locationsv141
  2. Primary and study completion pushed from May 14, 2026 to Jun 30, 2027v140
  3. Re-verified, no change to tracked fieldsv139
  4. Primary and study completion dates: Dec 31, 2025 to May 14, 2026 Site details revised at 2 of 130 sitesv138 Show 1 more changeShow less
    • Site details revised at 2 of 130 sites
  5. Study sites: 128 to 130v137
Show 45 earlier versionsHide 45 earlier versions
  1. Primary completion date: Jun 30, 2025 to Dec 31, 2025v136
  2. Study sites: 108 to 128v135
  3. Study sites: 123 to 108v134
  4. Primary completion date: Dec 31, 2024 to Jun 30, 2025 Completion date: Apr 1, 2025 to Dec 31, 2025 · Study sites revised (123)v133 Show 2 more changesShow less
    • Completion date: Apr 1, 2025 to Dec 31, 2025
    • Study sites revised (123)

    See this version in full on ClinicalTrials.gov ↗

  5. 4 versions Re-verified since Mar 27, 2024, no change to tracked fieldsv129-v132
  6. Site details revised at 1 of 123 sitesv128
  7. Site details revised at 3 of 123 sitesv127
  8. Re-verified, no change to tracked fieldsv126
  9. Study sites revised (123)v125 See this version in full on ClinicalTrials.gov ↗
  10. Enrollment target: estimated 700 to confirmed 534 Site details revised at 5 of 123 sitesv124 Show 1 more changeShow less
    • Site details revised at 5 of 123 sites
  11. Trial status: Recruiting to Active, Not Recruiting Study sites: 147 to 123v123 Show 1 more changeShow less
    • Study sites: 147 to 123
  12. 4 versions Re-verified since Jul 26, 2022, no change to tracked fieldsv119-v122
  13. Site details revised at 4 of 147 sitesv118
  14. Site details revised at 1 of 147 sitesv117
  15. Site details revised at 1 of 147 sitesv116
  16. Site details revised at 59 of 147 sitesv115
  17. Study sites revised (147)v114 See this version in full on ClinicalTrials.gov ↗
  18. Primary completion date: Dec 1, 2022 to Dec 31, 2024 Completion date: Dec 2, 2024 to Apr 1, 2025 · Site details revised at 28 of 147 sitesv113 Show 2 more changesShow less
    • Completion date: Dec 2, 2024 to Apr 1, 2025
    • Site details revised at 28 of 147 sites
  19. Study sites: 150 to 147v112
  20. Re-verified, no change to tracked fieldsv111
  21. Site details revised at 3 of 150 sitesv110
  22. Site details revised at 2 of 150 sitesv109
  23. Site details revised at 18 of 150 sites Eligibility criteria shortened, about 1 wordv108 Show 1 more changeShow less
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  24. Enrollment target: 500 to 700 Eligibility criteria shortened, about 26 wordsv107 Show 1 more changeShow less
    • Eligibility criteria shortened, about 26 words

    See this version in full on ClinicalTrials.gov ↗

  25. Study sites revised (150)v106 See this version in full on ClinicalTrials.gov ↗
  26. Study sites: 145 to 150v105
  27. Enrollment target: 300 to 500 Eligibility criteria expanded, about 13 words · Secondary endpoints: 7 to 12 · Study sites revised (145)v104 Show 3 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 7 to 12
    • Study sites revised (145)

    See this version in full on ClinicalTrials.gov ↗

  28. Site details revised at 1 of 145 sitesv103
  29. Site details revised at 1 of 145 sitesv102
  30. Re-verified, no change to tracked fieldsv101
  31. Site details revised at 1 of 145 sitesv100
  32. Site details revised at 1 of 145 sitesv99
  33. Site details revised at 1 of 145 sitesv98
  34. Site details revised at 1 of 145 sitesv97
  35. Site details revised at 1 of 145 sitesv96
  36. Primary completion date: Oct 31, 2019 to Dec 1, 2022 Completion date: Oct 31, 2020 to Dec 2, 2024 · Site details revised at 16 of 145 sitesv95 Show 2 more changesShow less
    • Completion date: Oct 31, 2020 to Dec 2, 2024
    • Site details revised at 16 of 145 sites
  37. Study sites: 138 to 145v94
  38. Eligibility criteria expanded, about 22 wordsv93 See this version in full on ClinicalTrials.gov ↗
  39. Study sites: 137 to 138v92
  • 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.
Roche/Genentech
366 trials monitored
See 33 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
and 9 more diseases
This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.
Trial Details
NCT Number NCT02568267
Lead Sponsor Hoffmann-La Roche
Conditions Breast Cancer, Cholangiocarcinoma, Colorectal Cancer, Head and Neck Neoplasms, Lymphoma, Large-Cell, Anaplastic, Melanoma, Neuroendocrine Tumors, Non-Small Cell Lung Cancer +8 more
Enrollment 534 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov