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Clinical trial

Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane in Patients With Breast Cancer

ID
Name
262180
Description
The purpose of this research study is to determine whether early administration of Dexrazoxane prevents Doxorubicin induced cardiotoxicity.
Trial arms
Trial start
2021-09-14
Estimated PCD
2024-10-31
Trial end
2025-10-31
Status
Recruiting
Phase
Early phase I
Treatment
Dexrazoxane
One dose of dexrazoxane
Arms:
Dexrazoxane 100mg/m2, Dexrazoxane 200mg/m2, Dexrazoxane 300mg/m2, Dexrazoxane 400mg/m2, Dexrazoxane 500mg/m2
Other names:
Zinecard
Size
25
Primary endpoint
Degradation of Topoisomerase 2 b
48 hours after administration
Eligibility criteria
Inclusion Criteria: * Women, * Age 18-65, * Not pregnant, Not currently breast feeding * No current illness, Exclusion Criteria: * Pregnancy, currently breast feeding * Current illness, * History of cardiac, or renal disease
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Each subject will receive one dose of dexrazoxane.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ESTIMATED'}}
Updated at
2024-02-16

1 organization

1 product

1 indication

Organization
University of Arkansas
Product
Dexrazoxane
Indication
Healthy