Spots Global Cancer Trial Database for Effect of Cabazitaxel on the QTc Interval in Cancer Patients
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Trial Identification
Brief Title: Effect of Cabazitaxel on the QTc Interval in Cancer Patients
Official Title: QT-Cab: An Open-Label Study to Investigate the Effect of Cabazitaxel on the QTc Interval in Cancer Patients
Study ID: NCT01087021
Conditions
Interventions
Study Description
Brief Summary: Primary Objective: * To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patients Secondary Objectives: * To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction), and QTcN (population specific correction) intervals * To assess the clinical safety of cabazitaxel * To assess cabazitaxel plasma concentrations at Cycle 1 at early timepoints (during infusion and up to 5h post end of infusion)
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sanofi-Aventis Investigational Site Number 840006, San Diego, California, United States
Sanofi-Aventis Investigational Site Number 840002, San Francisco, California, United States
Sanofi-Aventis Investigational Site Number 840005, Decatur, Illinois, United States
Sanofi-Aventis Investigational Site Number 840008, Wichita, Kansas, United States
Sanofi-Aventis Investigational Site Number 840010, Paducah, Kentucky, United States
Sanofi-Aventis Investigational Site Number 840007, Kansas City, Missouri, United States
Sanofi-Aventis Investigational Site Number 840009, Bethlehem, Pennsylvania, United States
Sanofi-Aventis Investigational Site Number 840003, Salt Lake City, Utah, United States
Sanofi-Aventis Investigational Site Number 056002, Bruxelles, , Belgium
Sanofi-Aventis Investigational Site Number 056001, Gent, , Belgium
Sanofi-Aventis Investigational Site Number 208002, Herlev, , Denmark
Sanofi-Aventis Investigational Site Number 208001, København Ø, , Denmark
Sanofi-Aventis Investigational Site Number 528001, Maastricht, , Netherlands
Sanofi-Aventis Investigational Site Number 752002, Lund, , Sweden
Sanofi-Aventis Investigational Site Number 752001, Uppsala, , Sweden
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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