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Named Patient Program for Olverembatinib (HQP1351)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05594758
Expanded Access Status : Available
First Posted : October 26, 2022
Last Update Posted : November 15, 2022
Sponsor:
Collaborator:
Tanner Pharma Group
Information provided by (Responsible Party):
Ascentage Pharma Group Inc.

Study Description
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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.

Intervention/treatment
Drug: Olverembatinib

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

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Olverembatinib
    Oral Olverembatinib
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05594758


Contacts
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Contact: Tanner Pharma 704-552-8408 olverembatinib@tannerpharma.com
Contact: NPP Core working Group 301-291-5658 NPP-olverembatinib@ascentage.com

Sponsors and Collaborators
Ascentage Pharma Group Inc.
Tanner Pharma Group
More Information
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Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ascentage Pharma Group Inc.
ClinicalTrials.gov Identifier: NCT05594758    
Other Study ID Numbers: NPP Olverembatinib
First Posted: October 26, 2022    Key Record Dates
Last Update Posted: November 15, 2022
Last Verified: November 2022
Keywords provided by Ascentage Pharma Group Inc.:
Named Patient Program