Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04040205 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv12
  2. Primary completion date: Jun 1, 2025 to Jun 1, 2027 Primary endpoints: 2 to 1 · Completion date: Jun 1, 2026 to Jun 1, 2027v11 Show 2 more changesShow less
    • Primary endpoints: 2 to 1
    • Completion date: Jun 1, 2026 to Jun 1, 2027

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jun 1, 2026 to Jun 1, 2025 Study sites: 5 to 4 · Completion date: Jun 1, 2027 to Jun 1, 2026v10 Show 2 more changesShow less
    • Study sites: 5 to 4
    • Completion date: Jun 1, 2027 to Jun 1, 2026
  4. Primary completion date: Sep 1, 2024 to Jun 1, 2026 Enrollment target: 45 to 44 · Completion date: Sep 1, 2025 to Jun 1, 2027 · Site contacts updated at 1 of 5 sitesv9 Show 3 more changesShow less
    • Enrollment target: 45 to 44
    • Completion date: Sep 1, 2025 to Jun 1, 2027
    • Site contacts updated at 1 of 5 sites
  5. Primary completion date: Sep 1, 2023 to Sep 1, 2024 Completion date: Sep 1, 2024 to Sep 1, 2025 · Eligibility criteria expanded, about 4 wordsv8 Show 2 more changesShow less
    • Completion date: Sep 1, 2024 to Sep 1, 2025
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 4 to 5v7
  2. Study sites: 3 to 4v6
  3. Re-verified, no change to tracked fieldsv5
  4. Study sites: 2 to 3v4
  5. Study sites: 1 to 2 Eligibility criteria expanded, about 41 words · Study description expanded, about 2 words · Study title shortened, about 3 wordsv3 Show 3 more changesShow less
    • Eligibility criteria expanded, about 41 words
    • Study description expanded, about 2 words
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Not Yet Recruiting to Recruiting Primary endpoints: 1 to 2 · Start date changed from estimate of Sep 1, 2019 to Oct 7, 2019 · Site details revisedv2 Show 3 more changesShow less
    • Primary endpoints: 1 to 2
    • Start date changed from estimate of Sep 1, 2019 to Oct 7, 2019
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  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 single-arm, phase II study that will enroll a total of 45 subjects. All subjects will have a confirmed diagnosis of metastatic or unresectable soft tissue sarcoma or bone sarcoma. All subjects must have intact Rb, identified at the time of screening, by immunohistochemistry testing of submitted tumor specimen. Subjects will receive Abemaciclib 200 mg twice daily until progression or discontinuation criteria are met.
Trial Details
NCT Number NCT04040205
Lead Sponsor Medical College of Wisconsin
Conditions Chondrosarcoma, Osteosarcoma, Soft Tissue Sarcoma
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov