Clinical trial NCT01087021: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms, Malignant
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-03-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in QT interval corrected calculation by Fridericia method
timeFrame: Cycle 1, Day 1
Secondary outcomes:
measure: 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
timeFrame: Cycle 1, Day 1
measure: Other ECG parameters : PR, QRS intervals and ECG morphology
timeFrame: Cycle 1, Day 1
measure: 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
timeFrame: up to treatment discontinuation + 30 days over a maximum study period of 20 months
measure: Cabazitaxel plasma concentrations, Cmax and partial AUC -
timeFrame: Cycle 1, Day 1
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sanofi-Aventis Investigational Site Number 840006
state: California
city: San Francisco
country: United States
facility: Sanofi-Aventis Investigational Site Number 840002
state: California
city: Decatur
country: United States
facility: Sanofi-Aventis Investigational Site Number 840005
state: Illinois
city: Wichita
country: United States
facility: Sanofi-Aventis Investigational Site Number 840008
state: Kansas
city: Paducah
country: United States
facility: Sanofi-Aventis Investigational Site Number 840010
state: Kentucky
city: Kansas City
country: United States
facility: Sanofi-Aventis Investigational Site Number 840007
state: Missouri
city: Bethlehem
country: United States
facility: Sanofi-Aventis Investigational Site Number 840009
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Sanofi-Aventis Investigational Site Number 840003
state: Utah
city: Bruxelles
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056002
city: Gent
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056001
city: Herlev
country: Denmark
facility: Sanofi-Aventis Investigational Site Number 208002
city: København Ø
country: Denmark
facility: Sanofi-Aventis Investigational Site Number 208001
city: Maastricht
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528001
city: Lund
country: Sweden
facility: Sanofi-Aventis Investigational Site Number 752002
city: Uppsala
country: Sweden
facility: Sanofi-Aventis Investigational Site Number 752001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: