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A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma

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

Record History

  1. Minor Completion pushed from Aug 31, 2026 to Feb 28, 2027 Eligibility criteria expanded, about 15 words · Site details revised at 1 of 11 sites · Publications: details revised at 2 of 2 entries Show 3 more changesShow less
    • Eligibility criteria expanded, about 15 words
    • Site details revised at 1 of 11 sites
    • Publications: details revised at 2 of 2 entries
  2. Minor Re-verified, no change to tracked fieldsv13
  3. Minor Completion date: Jun 30, 2026 to Aug 31, 2026v12
  4. Minor Re-verified, no change to tracked fieldsv11
  5. Minor Primary completion date changed from estimate of Sep 30, 2023 to Mar 10, 2023v10
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Primary completion date: Jun 30, 2023 to Sep 30, 2023v9
  2. Minor 2 versions Re-verified since Feb 3, 2022, no change to tracked fieldsv7-v8
  3. Minor Trial status: Recruiting to Active, Not Recruiting Site details revised at 11 of 11 sitesv6 Show 1 more changeShow less
    • Site details revised at 11 of 11 sites
  4. Minor Study sites: 8 to 11v5
  5. Minor Study sites: 2 to 8v4
  6. Minor Study sites: 1 to 2v3
  7. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jul 1, 2020 to Jul 8, 2020v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 1, 2020 to Jul 8, 2020
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
Trial Details
NCT Number NCT04458272
Lead Sponsor Daiichi Sankyo Co., Ltd.
Conditions WHO Grade II Glioma
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov