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A Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese Patients

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Feb 29, 2024 to Dec 30, 2024 Completion date: Jun 30, 2024 to Nov 30, 2025v7 Show 1 more changeShow less
    • Completion date: Jun 30, 2024 to Nov 30, 2025
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 25 to confirmed 12 · Primary completion date: Dec 31, 2023 to Feb 29, 2024 · Completion date: Dec 31, 2023 to Jun 30, 2024 · 2 morev6 Show 5 more changesShow less
    • Enrollment target: estimated 25 to confirmed 12
    • Primary completion date: Dec 31, 2023 to Feb 29, 2024
    • Completion date: Dec 31, 2023 to Jun 30, 2024
    • Site details revised at 4 of 4 sites
    • Collaborator revised

    See this version in full on ClinicalTrials.gov ↗

  3. Primary and study completion dates: Dec 31, 2021 to Dec 31, 2023v5
  4. Primary completion date: Dec 31, 2020 to Dec 31, 2021 Site details revised at 1 of 4 sitesv4 Show 1 more changeShow less
    • Site details revised at 1 of 4 sites
  5. Site details revised at 2 of 4 sitesv3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 4 · Primary completion date: Oct 15, 2020 to Dec 31, 2020 · Completion date: Apr 15, 2021 to Dec 31, 2021 · 2 morev2 Show 5 more changesShow less
    • Study sites: 0 to 4
    • Primary completion date: Oct 15, 2020 to Dec 31, 2020
    • Completion date: Apr 15, 2021 to Dec 31, 2021
    • Start date changed from estimate of Oct 15, 2019 to Jan 8, 2020
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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, non-randomized clinical study to evaluate the pharmacokinetic (PK) profiles, safety, tolerability and preliminary efficacy of oral abexinostat monotherapy in patients with non-Hodgkin's lymphoma who have failed standard of care, and thereby to determine the pharmacokinetic (PK) parameters, the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) of the oral monotherapy of abexinostat.
Trial Details
NCT Number NCT04024696
Lead Sponsor Xynomic Pharmaceuticals, Inc.
Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions Non Hodgkin Lymphoma
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov