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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 3 of 17 sitesv11
  2. Enrollment target: 85 to 276 Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026v10 Show 1 more changeShow less
    • Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026
  3. Study sites: 4 to 17v9
  4. Primary and study completion dates: Dec 31, 2023 to Dec 31, 2025v8
  5. Primary and study completion dates: Dec 31, 2022 to Dec 31, 2023 Study sites: 3 to 4v7 Show 1 more changeShow less
    • Study sites: 3 to 4
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 1 to 3 Eligibility criteria expanded, about 144 wordsv6 Show 1 more changeShow less
    • Eligibility criteria expanded, about 144 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Nov 29, 2021 to Dec 31, 2022 Completion date: Feb 28, 2022 to Dec 31, 2022v5 Show 1 more changeShow less
    • Completion date: Feb 28, 2022 to Dec 31, 2022
  3. Study title revisedv4 See this version in full on ClinicalTrials.gov ↗
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 1, 2020 to Jan 20, 2020v3 Show 1 more changeShow less
    • Start date changed from estimate of Feb 1, 2020 to Jan 20, 2020
  5. Start date: Dec 20, 2019 to Feb 1, 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.
Trial Details
NCT Number NCT04192344
Lead Sponsor Abbisko Therapeutics Co, Ltd
Conditions Neoplasms, Tenosynovial Giant Cell Tumor
Enrollment 276 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov