Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT05594758
Status:
AVAILABLE
Last Update Posted:
2024-02-07
First Post:
2022-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Named Patient Program for Olverembatinib (HQP1351)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C579813', 'term': 'olverembatinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2022-10-21', 'studyFirstSubmitQcDate': '2022-10-21', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Named Patient Program']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n• 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.\n\nExclusion Criteria:\n\n* 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\n* Existing risks of serious Venous thromboembolic events (VTEs), including deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis\n* Existing serious heart conditions, including acute/chronic heart failure, coronary artery disease\n* Existing conditions of severe liver malfunction\n* Existing conditions of severe myelosuppression\n* Existing conditions of severe hemorrhage\n* Pregnant or baby feeding'}, 'identificationModule': {'nctId': 'NCT05594758', 'briefTitle': 'Named Patient Program for Olverembatinib (HQP1351)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascentage Pharma Group Inc.'}, 'officialTitle': 'Named Patient Program for Providing Access to Olverembatinib (HQP1351) to Countries Where the Drug is Not Available', 'orgStudyIdInfo': {'id': 'NPP Olverembatinib'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Olverembatinib', 'type': 'DRUG', 'description': 'Oral Olverembatinib'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tanner Pharma', 'role': 'CONTACT', 'email': 'olverembatinib@tannerpharma.com', 'phone': '704-552-8408'}, {'name': 'NPP Core working Group', 'role': 'CONTACT', 'email': 'NPP-olverembatinib@ascentage.com', 'phone': '301-291-5658'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascentage Pharma Group Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Tanner Pharma Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}