Overview

A Crossover Bioequivalence Study of Intravenously Administered ATI0918 and DOXIL/CAELYX in Patients With Ovarian Cancer

Status:
Unknown status

Trial end date:
2015-12-01

Target enrollment:

Participant gender:

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).

Phase:

Phase 1

Details

Lead Sponsor:

Azaya Therapeutics, Inc.

Treatments:

Doxorubicin
Liposomal doxorubicin