QT-Cab: An Open-Label Study to Investigate the Effect of Cabazitaxel on the QTc Interval in Cancer Patients
The main period of the study consists of a maximum of 21-day screening phase, then first 2
treatment cycles with cabazitaxel. End of main period will be Cycle 3 or 30 days after last
dose if patient discontinues study after 1 or 2 treatment cycles. The duration for a patient
for the main period of the study will be about 9 to 10 weeks (screening, 2 cycles).
After Cycle 2, patients will have the option to continue to receive cabazitaxel and should
be followed for safety reporting until 30 days after the last dose of cabazitaxel.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change from baseline in QT interval corrected calculation by Fridericia method
Cycle 1, Day 1
Yes
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
TES10884
NCT01087021
March 2010
November 2011
Name | Location |
---|---|
Sanofi-Aventis Investigational Site Number 840006 | San Diego, California 92103 |
Sanofi-Aventis Investigational Site Number 840002 | San Francisco, California 94115 |
Sanofi-Aventis Investigational Site Number 840005 | Decatur, Illinois 62526 |
Sanofi-Aventis Investigational Site Number 840008 | Wichita, Kansas 67214 |
Sanofi-Aventis Investigational Site Number 840010 | Paducah, Kentucky 42002 |
Sanofi-Aventis Investigational Site Number 840007 | Kansas City, Missouri 64128 |
Sanofi-Aventis Investigational Site Number 840009 | Bethlehem, Pennsylvania 18015 |
Sanofi-Aventis Investigational Site Number 840003 | Salt Lake City, Utah 84132 |