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Abemaciclib and Letrozole to Treat Endometrial Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Dec 1, 2024 to Dec 1, 2026
    • Study completion date: Dec 1, 2025 to Dec 31, 2026
    v24
  2. Primary completion date: Dec 1, 2023 to Dec 1, 2024v23 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 50 to confirmed 53
    • Study sites: 30 to 29
    • Study completion date: Sep 1, 2024 to Dec 1, 2025
  3. Site contacts updated at 1 of 30 sitesv22
  4. Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Jun 1, 2023 to Dec 1, 2023
    • Study sites: 29 to 30
    v21
  5. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 30 to 29
    v20
Show 18 earlier versionsHide 18 earlier versions
  1. Primary completion date: Jun 1, 2022 to Jun 1, 2023
    • Study sites: 25 to 30
    • Study completion date: Jun 1, 2023 to Sep 1, 2024
    v19
  2. Study sites: 23 to 25v18
  3. Study sites: 22 to 23v17
  4. Study sites: 19 to 22v16
  5. Primary endpoint revised
    • Study sites: 15 to 19
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints: 2 to 3
    v15
  6. Study sites: 12 to 15v14
  7. Study sites: 11 to 12v13
  8. Study sites: 10 to 11v12
  9. Study sites: 9 to 10v11
  10. Collaborators expanded, about 4 wordsv10
  11. Study sites: 8 to 9v9
  12. Study sites: 7 to 8v8
  13. Study sites: 6 to 7v7
  14. Study sites: 4 to 6v6
  15. Study sites: 3 to 4v5
  16. Study sites: 2 to 3v4
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Sep 15, 2020 to Oct 10, 2020
    v3
  18. Start date: Jun 1, 2020 to Sep 15, 2020
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 31 words
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a phase II single arm trial to determine the percentage of patients without evidence of disease progression on abemaciclib and letrozole in advanced stage, persistent or recurrent endometrioid endometrial cancer at 6 months. Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal.
Trial Details
NCT Number NCT04393285
Lead Sponsor Gynecologic Oncology Group
Collaborators: Eli Lilly and Company
Conditions
(from sponsor)		 Endometrial Cancer
Related terms Endometrial Neoplasms
Enrollment 53 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov