Cancer Clinical Trial
Official title:
A Phase 1, Single-blind, Randomized, Two-way, Crossover Bioequivalence Study of Intravenously Administered ATI 0918 in Patients With Ovarian Cancer That Has Progressed or Recurred After Platinum-based Chemotherapy
The purpose of this study is to find the answers to the following research question(s):
1. Is the study drug equivalent to the approved drug, Doxil/Caelyx, and does it act the same
way in the body as the approved drug?
ATI-0918 is believed to be a generic of Doxil/Caelyx and this is what the study is trying to
prove. All people who participate in this study will receive the research study medication
(ATI-0918) and Doxil/Caelyx in addition to best supportive care (treatment for symptoms).
The study drug being tested in this study works the same as the FDA (government) approved
drug doxorubicin HCl. ATI-0918 is a generic (the same) formulation of doxorubicin HCl being
delivered (given to the patient).
n/a
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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