Effect of Cabazitaxel on the QTc Interval in Cancer Patients

Neoplasms, Malignant Clinical Trial

— QT-Cab  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087021
• Other study ID #: TES10884
• Secondary ID: 2009-016864-35U1
• Status: Completed
• Phase: Phase 1
• First received: March 12, 2010
• Last updated: December 15, 2011
• Start date: March 2010
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

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 information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, and a treatment with a novel taxane agent is considered.

Exclusion criteria:

• Conditions with screening ECG repolarization difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: high degree AV block, pace-maker, atrial fibrillation or flutter

• QTcF >480 msec on screening Electrocardiogram (ECG)

• Significant hypokalemia at screening (serum potassium <3.5 mMol/L)

• Significant hypomagnesemia at screening (serum magnesium <0.7 mMol/L) (Note: Patient may be enrolled after correction of these laboratory abnormalities)

• Patient receives (and cannot discontinue), or is scheduled to receive a QT-prolonging drug

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Neoplasms, Malignant

Intervention

Drug:
• Cabazitaxel (XRP6258)
Pharmaceutical form:solution for infusion Route of administration: intravenous

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Investigational Site Number 056002	Bruxelles
Belgium	Sanofi-Aventis Investigational Site Number 056001	Gent
Denmark	Sanofi-Aventis Investigational Site Number 208002	Herlev
Denmark	Sanofi-Aventis Investigational Site Number 208001	København Ø
Netherlands	Sanofi-Aventis Investigational Site Number 528001	Maastricht
Sweden	Sanofi-Aventis Investigational Site Number 752002	Lund
Sweden	Sanofi-Aventis Investigational Site Number 752001	Uppsala
United States	Sanofi-Aventis Investigational Site Number 840009	Bethlehem	Pennsylvania
United States	Sanofi-Aventis Investigational Site Number 840005	Decatur	Illinois
United States	Sanofi-Aventis Investigational Site Number 840007	Kansas City	Missouri
United States	Sanofi-Aventis Investigational Site Number 840010	Paducah	Kentucky
United States	Sanofi-Aventis Investigational Site Number 840003	Salt Lake City	Utah
United States	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 840008	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in QT interval corrected calculation by Fridericia method		Cycle 1, Day 1	Yes
Secondary	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	Yes
Secondary	Other ECG parameters : PR, QRS intervals and ECG morphology		Cycle 1, Day 1	Yes
Secondary	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	Yes
Secondary	Cabazitaxel plasma concentrations, Cmax and partial AUC -		Cycle 1, Day 1	No