NCT01087021

Effect of Cabazitaxel on the QTc Interval in Cancer Patients

QT-Cab: An Open-Label Study to Investigate the Effect of Cabazitaxel on the QTc Interval in Cancer Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms, Malignant

Interventions

Type	Name	Description
DRUG	Cabazitaxel (XRP6258)	Pharmaceutical form:solution for infusion Route of administration: intravenous

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-04-01
• Completion: 2011-11-01
• First posted: 2010-03-15
• Last updated: 2011-12-16

Locations

15 sites across 5 countries: United States, Belgium, Denmark, Netherlands, Sweden