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Named Patient Program for Olverembatinib (HQP1351)

Sponsor
Ascentage Pharma Group Inc. (Industry)
Overall Status
Available
CT.gov ID
NCT05594758
Collaborator
Tanner Pharma Group (Other)

Study Details

Study Description

Brief Summary

This program will allow eligible patients access to Ascentage Pharma's novel drug candidate Olverembatinib (approved in China) on a named patient basis in over 100 countries ( with the exception of the USA and China) and regions where the drug is not available.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Olverembatinib is a novel third generation BCR-ABL inhibitor that can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation. Olverembatinib is approved in China for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CP-CML) or accelerated-phase CML (AP-CML) harboring the T315I mutation as confirmed by a validated diagnostic test1.

    Study Design

    Study Type:
    Expanded Access
    Official Title:
    Named Patient Program for Providing Access to Olverembatinib (HQP1351) to Countries Where the Drug is Not Available

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 99 Years
      Sexes Eligible for Study:
      All
      Inclusion Criteria:

      • Patients who are suitable to receive Olverembatinib and for whom there is reasonable expectation that Olverembatinib may provide clinical benefit based on the medical judgment of their prescribing physician.

      Exclusion Criteria:

      • Existing risks of serious Arterial occlusive events (AOE), including myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and recent revascularization procedures

      • Existing risks of serious Venous thromboembolic events (VTEs), including deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis

      • Existing serious heart conditions, including acute/chronic heart failure, coronary artery disease

      • Existing conditions of severe liver malfunction

      • Existing conditions of severe myelosuppression

      • Existing conditions of severe hemorrhage

      • Pregnant or baby feeding

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Ascentage Pharma Group Inc.
      • Tanner Pharma Group

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Ascentage Pharma Group Inc.
      ClinicalTrials.gov Identifier:
      NCT05594758
      Other Study ID Numbers:
      • NPP Olverembatinib
      First Posted:
      Oct 26, 2022
      Last Update Posted:
      Nov 15, 2022
      Last Verified:
      Nov 1, 2022
      Keywords provided by Ascentage Pharma Group Inc.
      Named Patient Program

      Study Results

      No Results Posted as of Nov 15, 2022