Effect of Cabazitaxel on the QTc Interval in Cancer Patients
- Registration Number
- NCT01087021
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description cabazitaxel Cabazitaxel (XRP6258) At every cycle (every 3 weeks), on Day 1, patients will receive cabazitaxel, administered by intravenous (IV) infusion over 1 hour, at 25 mg/m2. An IV premedication regimen composed of up to 4 treatments (antihistamine, corticosteroids, H2 antagonist other than cimetidine at all cycles, plus palonosetron at cycle 1) will be administered before cabazitaxel infusion.
- Primary Outcome Measures
Name Time Method Change from baseline in QT interval corrected calculation by Fridericia method Cycle 1, Day 1
- Secondary Outcome Measures
Name Time Method Change from baseline in Heart rate, QT, QTcB (QT interval corrected calculation by Bazett method) and QTcN (QT interval with a population-specific correction formulae) intervals Cycle 1, Day 1 Other ECG parameters : PR, QRS intervals and ECG morphology Cycle 1, Day 1 Clinical safety based on adverse events, serious adverse event, laboratory assessments according to the National Cancer Institute- Common Terminology Criteria for Adverse Events v4.0 grade scaling up to treatment discontinuation + 30 days over a maximum study period of 20 months Cabazitaxel plasma concentrations, Cmax and partial AUC - Cycle 1, Day 1
Trial Locations
- Locations (15)
Sanofi-Aventis Investigational Site Number 056002
🇧🇪Bruxelles, Belgium
Sanofi-Aventis Investigational Site Number 840006
🇺🇸San Diego, California, United States
Sanofi-Aventis Investigational Site Number 840005
🇺🇸Decatur, Illinois, United States
Sanofi-Aventis Investigational Site Number 840002
🇺🇸San Francisco, California, United States
Sanofi-Aventis Investigational Site Number 208001
🇩🇰København Ø, Denmark
Sanofi-Aventis Investigational Site Number 840008
🇺🇸Wichita, Kansas, United States
Sanofi-Aventis Investigational Site Number 840003
🇺🇸Salt Lake City, Utah, United States
Sanofi-Aventis Investigational Site Number 528001
🇳🇱Maastricht, Netherlands
Sanofi-Aventis Investigational Site Number 208002
🇩🇰Herlev, Denmark
Sanofi-Aventis Investigational Site Number 752001
🇸🇪Uppsala, Sweden
Sanofi-Aventis Investigational Site Number 056001
🇧🇪Gent, Belgium
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 840010
🇺🇸Paducah, Kentucky, United States
Sanofi-Aventis Investigational Site Number 752002
🇸🇪Lund, Sweden