Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04488822 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT

Study acronym: PLX3397
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion date: Feb 28, 2026 to Mar 31, 2027v15
  2. Re-verified, no change to tracked fieldsv14
  3. Eligibility criteria revisedv13 See this version in full on ClinicalTrials.gov ↗
  4. Completion date: Mar 30, 2024 to Feb 28, 2026v12
  5. Results first posted: Apr 27, 2023 Secondary endpoints: details revised at 3 of 9 entriesv11 Show 1 more changeShow less
    • Secondary endpoints: details revised at 3 of 9 entries
Show 9 earlier versionsHide 9 earlier versions
  1. Primary endpoint revised Enrollment target: estimated 35 to confirmed 40 · Primary completion date: Apr 25, 2022 to Oct 27, 2021 · Start date: Sep 2, 2020 to Sep 25, 2020 · 1 morev10 Show 4 more changesShow less
    • Enrollment target: estimated 35 to confirmed 40
    • Primary completion date: Apr 25, 2022 to Oct 27, 2021
    • Start date: Sep 2, 2020 to Sep 25, 2020
    • Secondary endpoints revised (9)

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date changed from estimate of Apr 1, 2022 to Apr 25, 2022v9
  3. Primary completion date: Jan 1, 2022 to Apr 1, 2022 Completion date: Mar 30, 2022 to Mar 30, 2024v8 Show 1 more changeShow less
    • Completion date: Mar 30, 2022 to Mar 30, 2024
  4. Trial status: Recruiting to Active, Not Recruiting Site details revised at 9 of 9 sitesv7 Show 1 more changeShow less
    • Site details revised at 9 of 9 sites
  5. Study sites: 7 to 9v6
  6. Study sites: 4 to 7v5
  7. Study sites: 3 to 4v4
  8. Study sites: 2 to 3v3
  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Sep 30, 2020 to Sep 2, 2020v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 30, 2020 to Sep 2, 2020
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will assess pexidartinib in adult participants with symptomatic TGCT that is associated with severe morbidity or functional limitations and not amendable to improvement with surgery.
Trial Details
NCT Number NCT04488822
Lead Sponsor Daiichi Sankyo Co., Ltd.
Conditions Tenosynovial Giant Cell Tumor
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov