SARC041: Study of Abemaciclib Versus Placebo in Patients With Advanced Dedifferentiated Liposarcoma

StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Dec 2025 → Dec 2027
See other at-risk trials from Sarcoma Alliance for Research through Collaboration

Record History

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  1. Primary completion pushed from Dec 2025 to Dec 2027 Show 4 more changesShow less
    • Study completion pushed from Dec 2026 to Dec 2027
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site details revised at 1 of 9 sites
  2. Primary completion date: May 2024 to Dec 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Nov 2024 to Dec 2026
    • Site details revised at 9 of 9 sites
    v13
  3. Study sites: 8 to 9v12
  4. Study sites: 7 to 8v11
  5. Site contacts updated at 1 of 7 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 5 to 7
    • Eligibility criteria expanded, about 54 words
    v9
  2. Study sites: 4 to 5v8
  3. Study sites: 2 to 4v7
  4. Study sites: 1 to 2v6
  5. Re-verified, no change to tracked fieldsv5
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2021 to Nov 11, 2021
    • Study sites: 0 to 1
    • Study completion date: Sep 2024 to Nov 2024
    v4
  7. Interventions: Abemaciclib (Drug) to Abemaciclib (Drug), Placebo (Drug)
    • Study title revised
    v3
  8. Study title shortened, about 4 wordsv2
  1. Study First Submitted
  • 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 3 randomized double-blind study of abemaciclib versus placebo. Patients with progression of disease will cross over to open label abemaciclib.
Trial Details
NCT Number NCT04967521
Lead Sponsor Sarcoma Alliance for Research through Collaboration
Collaborators: Eli Lilly and Company
Conditions
(from sponsor)		 Advanced Dedifferentiated Liposarcoma
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov