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Sacituzumab Govitecan in Recurrent Glioblastoma

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Feb 2026 to Feb 2027
    • Study completion date: Aug 2026 to Feb 2028
    • Site contacts updated at 1 of 3 sites
    v13
  2. Primary endpoint revisedv12 Show 5 more changesShow less
    • Enrollment target: 40 to 32
    • Eligibility criteria expanded, about 53 words
    • Secondary endpoints expanded, about 8 words
    • Study description expanded, about 104 words
    • Study sites revised (3)
  3. Primary completion date: Aug 2024 to Feb 2026
    • Study completion date: Feb 2025 to Aug 2026
    v11
  4. Primary completion date: Feb 2024 to Aug 2024v10
  5. Study sites: 2 to 3v9
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 3 to 2
    • Start date changed from estimate of Jan 2022 to Jan 6, 2022
    v8
  2. Start date: Nov 2021 to Jan 2022
    • Study sites: 2 to 3
    v7
  3. Start date: Sep 2021 to Nov 2021v6
  4. Start date: Jun 2021 to Sep 2021v5
  5. Start date: Feb 2021 to Jun 2021v4
  6. Start date: Nov 1, 2020 to Feb 2021
    • Primary completion date: Nov 1, 2023 to Feb 2024
    • Study completion date: Nov 1, 2024 to Feb 2025
    v3
  7. Study title shortened, about 3 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 an open-label single arm study. All patients will receive the study drug. The aim of the study is to compare overall survival (OS) of patients with recurrent brain tumor, known as Glioblastoma (GBM) having high levels of a protein, Trophoblast cell surface antigen 2 (Trop-2), expression on treatment with Sacituzumab Govitecan (SG) versus lomustine only which has been used in the past.
Trial Details
NCT Number NCT04559230
Lead Sponsor The University of Texas Health Science Center at San Antonio
Conditions
(from sponsor)		 Recurrent Glioblastoma
Related terms Glioblastoma
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov