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A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 27 to 28v28
  2. Study sites: 26 to 27v27
  3. Study sites: 25 to 26v26
  4. Study sites: 24 to 25v25
  5. Study sites: 23 to 24v24
  6. Trial sites expanded: 14 → 22 locationsv23
  7. Study sites: 14 to 22v22
  8. Site contacts updated at 2 of 14 sitesv21
  9. Study sites: 12 to 14v20
  10. Study sites: 11 to 12v19
  11. Site contacts updated at 1 of 11 sitesv18
  12. Study sites: 10 to 11v17
  13. Site contacts updated at 1 of 10 sitesv16
  14. Study sites: 9 to 10v15
  15. Study sites: 10 to 9v14
  16. Interventions: DCC-3116 (Drug), Ripretinib (Drug) to Inlexisertib (Drug), Ripretinib (Drug)
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 4 of 9 entries
    • Study title expanded, about 1 word
    v13
  17. Site contacts updated at 7 of 10 sitesv12
  18. Study sites: 9 to 10
    • Study completion date: Jun 2027 to Mar 2029
    • Eligibility criteria shortened, about 18 words
    v11
  19. Study sites: 8 to 9v10
  20. Enrollment target: 170 to 94v9 Show 4 more changesShow less
    • Interventions: Cetuximab (Drug), DCC-3116 (Drug), Encorafenib (Drug), Ripretinib (Drug) to DCC-3116 (Drug), Ripretinib (Drug)
    • Eligibility criteria shortened, about 19 words
    • Secondary endpoints revised (9)
    • Collaborators shortened, about 1 word
  21. Study sites: 6 to 8v8
  22. Site contacts updated at 1 of 6 sitesv7
  23. Study sites: 3 to 6v6
  24. Study sites: 2 to 3v5
  25. Study sites: 1 to 2v4
  26. Start date changed from estimate of Aug 2023 to Sep 28, 2023v3
  27. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Jul 2023 to Aug 2023
    v2
  28. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase 1/2, multicenter, open-label (unless otherwise specified in a combination-specific module) study of inlexisertib in combination with anticancer therapies. Modules within the master protocol are defined according to different combinations of inlexisertib with other anticancer agents.
Trial Details
NCT Number NCT05957367
Lead Sponsor Deciphera Pharmaceuticals, LLC
Conditions
(from sponsor)		 GIST
Related terms Gastrointestinal Stromal Tumors
Enrollment 94 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov