A Pivotal Pharmacokinetic Bioequivalence Study Comparing Generic to Reference Liposome-Encapsulated Doxorubicin Hydrochloride in Subjects with Epithelial Ovarian Carcinoma Who Have Failed Platinum-Based Chemotherapy
Sponsor: |
Tolmar |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAQ6298 |
Contact: |
June Hou: 212-305-3410 / jh3558@cumc.columbia.edu |
This research is being done to find out if TOLMAR formulation behaves in the body the same way DOXOrubicin does. This will be done by comparing the amount of doxorubicin in subjects' blood after they are given TOLMAR formulation compared to the amount of doxorubicin in the blood after they are given DOXOrubicin. This is a pharmacokinetic study. Pharmacokinetic studies look at what happens to a drug in the body. One way to do this is to take blood samples to see how much drug is in the blood at different points in time after a drug has been given. Several blood samples will be taken over a period of time before and after receiving drug in this study, which will be useful to determine whether the TOLMAR doxorubicin formulation provides the same amount of doxorubicin in the blood as DOXOrubicin.
This study is closed
Investigator
June Hou, MD
Have you been diagnosed with ovarian cancer? |
Yes |
No |