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Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)

Study acronym: APROMISS
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial status: Active, Not Recruiting to Recruitingv25 Show 8 more changesShow less
    • Primary completion date: Dec 2024 to Dec 2027
    • Primary endpoints: 2 to 3
    • Study sites: 23 to 24
    • Study completion date: Jun 2025 to Dec 2028
    • Interventions: AL3818 (Drug), AL3818 or placebo (Drug), Dacarbazine (Drug) to AL3818 (Drug), AL3818 or placebo (Drug), Dacarbazine (Drug), Digoxin (0.25mg) (Drug), Midazolam 2 mg for CYP3A4 phenotyping (Drug)…
    • Eligibility criteria expanded, about 56 words
    • Study description expanded, about 151 words
    • Study arms: 6 to 7
  2. Primary completion date: Dec 2023 to Dec 2024
    • Study completion date: Apr 2024 to Jun 2025
    v24
  3. Primary completion date: Dec 2022 to Dec 2023
    • Study completion date: Apr 2023 to Apr 2024
    v23
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 24 to 23
    • Study description revised
    v22
  5. Study sites: 23 to 24v21
Show 19 earlier versionsHide 19 earlier versions
  1. Eligibility criteria revised
    • Study description expanded, about 23 words
    • Site contacts updated at 1 of 23 sites
    v20
  2. Primary completion date: Apr 2021 to Dec 2022
    • Study sites: 20 to 23
    • Study completion date: Aug 2021 to Apr 2023
    • Study description revised
    v19
  3. Site contacts updated at 1 of 20 sitesv18
  4. Site contacts updated at 1 of 20 sitesv17
  5. Enrollment target: 219 to 325v16 Show 6 more changesShow less
    • Study sites: 17 to 20
    • Interventions: AL 3818 (Drug), Dacarbazine (Drug) to AL3818 (Drug), AL3818 or placebo (Drug), Dacarbazine (Drug)
    • Eligibility criteria expanded, about 226 words
    • Study description expanded, about 147 words
    • Study arms: 5 to 6
    • Study title shortened, about 2 words
  6. Site contacts updated at 2 of 17 sitesv15
  7. Study sites: 15 to 17v14
  8. Study sites: 14 to 15v13
  9. Study sites: 11 to 14v12
  10. Study sites: 10 to 11v11
  11. Study sites: 9 to 10v10
  12. Site contacts updated at 1 of 9 sitesv9
  13. Study sites: 8 to 9v8
  14. Study sites: 6 to 8v7
  15. Study sites: 4 to 6v6
  16. Study sites: 3 to 4v5
  17. Enrollment target: 216 to 219v4 Show 4 more changesShow less
    • Study sites: 1 to 3
    • Start date changed from estimate of Jun 15, 2017 to Aug 15, 2017
    • Secondary endpoints: 3 to 2
    • Study description shortened, about 8 words
  18. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 2017 to Jun 15, 2017
    • Study sites: 0 to 1
    v3
  19. Start date: Feb 2017 to Apr 2017
    • Primary completion date: Feb 2021 to Apr 2021
    • Study completion date: Jun 2021 to Aug 2021
    • Secondary endpoints: details revised at 1 of 3 entries
    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.
THIS STUDY IS CURRENTLY RECRUITING PATIENTS WITH ALVEOLAR SOFT PART SARCOMA ONLY AND IS NO LONGER RECRUITING PATIENTS WITH SYNOVIAL SARCOMA OR LEIOMYOSARCOMA. This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.
Trial Details
NCT Number NCT03016819
Lead Sponsor Advenchen Laboratories, LLC
Conditions
(from sponsor)		 Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma, Soft-Tissue Sarcoma
Related terms Leiomyosarcoma, Sarcoma, Sarcoma, Alveolar Soft Part, Sarcoma, Synovial
Enrollment 325 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov