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Clinical Trial Summary

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).


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01715168
Study type Interventional
Source Azaya Therapeutics, Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date October 2012
Completion date December 2015

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