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Study of Olverembatinib (HQP1351) in Patients With CML-CP

Study acronym: POLARIS-2
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 6 months later Dec 2025 → Jun 30, 2027
Primary endpoint reworded 2 of 2 changed
See other at-risk trials from Ascentage Pharma Group Inc.

Record History

  1. Primary completion pushed from Dec 2025 to Jun 30, 2027 Primary endpoint(s) modified · Enrollment increased: 285 → 333 participants · Trial sites expanded: 1 → 163 locations · 5 more Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 285 → 333 participants
    • Trial sites expanded: 1 → 163 locations
    • Completion pushed from Feb 2026 to Jul 10, 2028
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints expanded, about 70 words
    • Study description shortened, about 40 words
    • Study title revised
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 2024 to Feb 5, 2024 · Study description shortened, about 31 words · Site details revised · 1 morev2 Show 4 more changesShow less
    • Start date changed from estimate of May 2024 to Feb 5, 2024
    • Study description shortened, about 31 words
    • Site details revised
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B). Patients who meet ELN 2025 failure criteria while receiving bosutinib in Part A may be able to receive olverembatinib in crossover follow-on study.
Trial Details
NCT Number NCT06423911
Lead Sponsor Ascentage Pharma Group Inc.
Conditions Chronic Myeloid Leukemia, CML, CML, Chronic Phase
Enrollment 333 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov