Ignite Creation Date:
2024-05-05 @ 10:20 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01087021
Status:
COMPLETED
Last Update Posted:
2011-12-16
First Post:
2010-03-12
Brief Title:
Effect of Cabazitaxel on the QTc Interval in Cancer Patients
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
QT-Cab An Open-Label Study to Investigate the Effect of Cabazitaxel on the QTc Interval in Cancer Patients
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QT-Cab
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 Bazetts 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
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 Bazetts 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1116-5677 | OTHER | UTN | None |
| 2009-016864-35 | EUDRACT_NUMBER | None | None |