Named Patient Program for Olverembatinib (HQP1351)

NCT05594758 | Unknown

• 1 other identifier: NPP Olverembatinib
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Interventions

Olverembatinib DRUG

Oral Olverembatinib

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ascentage Pharma Group Inc.: lead
• Tanner Pharma Group: collaborator

MeSH Terms

Interventions

olverembatinib

Central Study Contacts

Tanner Pharma

CONTACT

704-552-8408; olverembatinib@tannerpharma.com

NPP Core working Group

CONTACT

301-291-5658; NPP-olverembatinib@ascentage.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Last Updated: February 7, 2024

Record last verified: 2024-02