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APG-115 in Salivary Gland Cancer Trial

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion moved earlier from Jul 2026 to Jan 19, 2026v21
  2. Primary completion date: May 2026 to Jul 2026
    • Study completion date: Nov 2026 to Jan 2027
    v20
  3. Primary completion date: Dec 2025 to May 2026
    • Study completion date: Jun 2026 to Nov 2026
    v19
  4. Primary completion date: Jun 2025 to Dec 2025
    • Study completion date: Dec 2025 to Jun 2026
    v18
  5. Primary completion date: Dec 2024 to Jun 2025
    • Study completion date: Jun 2025 to Dec 2025
    v17
Show 15 earlier versionsHide 15 earlier versions
  1. Primary completion date: Jul 2024 to Dec 2024
    • Study completion date: Jan 2025 to Jun 2025
    v16
  2. Trial status: Suspended to Active, Not Recruiting
    • Enrollment target: estimated 34 to confirmed 41
    v15
  3. Trial status: Recruiting to Suspended Sponsor's reason: enrollment has been placed on hold, pending evaluability assessment
    • Site details revised at 3 of 3 sites
    v14
  4. Re-verified, no change to tracked fieldsv13
  5. Site details revised at 1 of 3 sitesv12
  6. Start date: Oct 22, 2019 to Oct 28, 2019v11
  7. Lead sponsor: Ascentage Pharma Group Inc. to University of Michigan Rogel Cancer Centerv10 Show 9 more changesShow less
    • Enrollment target: 62 to 34
    • Primary completion date: Sep 15, 2022 to Jul 2024
    • Study sites: 2 to 3
    • Study completion date: Dec 15, 2022 to Jan 2025
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints expanded, about 16 words
    • Study description shortened, about 94 words
    • Collaborator revised
    • Study title shortened, about 4 words
  8. Site contacts updated at 1 of 2 sitesv9
  9. Re-verified, no change to tracked fieldsv8
  10. Start date: Oct 25, 2019 to Oct 22, 2019v7
  11. Interventions: APG115 + Carboplatin (Drug), APG115 mono-therapy (Drug), Part 2 (Other) to APG-115 (Drug), Carboplatin (Drug)
    • Eligibility criteria expanded, about 27 words
    • Study description expanded, about 1 word
    • Study title shortened, about 2 words
    v6
  12. Study sites: 1 to 2v5
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 25, 2019 to Oct 25, 2019
    • Site details revised
    v4
  14. Start date: Mar 15, 2019 to Sep 25, 2019v3
  15. Study title shortened, about 1 wordv2
  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.
This is a phase I/II trial to evaluate the efficacy of APG-115 +/- Carboplatin for the treatment p53 wild-type malignant salivary gland cancer. Part 1 consisted of 2 arms, arm A (APG-115 monotherapy) and arm B (APG-115 + Carboplatin) and was terminated early. Part 2 is a single arm study (APG-115 monotherapy).
Trial Details
NCT Number NCT03781986
Lead Sponsor University of Michigan Rogel Cancer Center
Collaborators: Ascentage Pharma Group Inc.
Conditions
(from sponsor)		 Malignant Salivary Gland Cancer, Salivary Gland Cancer
Related terms Carcinoma, Adenoid Cystic, Salivary Gland Neoplasms
Enrollment 41 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov