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


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms, Malignant

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Change from baseline in QT interval corrected calculation by Fridericia method

Outcome Time Frame:

Cycle 1, Day 1

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

TES10884

NCT ID:

NCT01087021

Start Date:

March 2010

Completion Date:

November 2011

Related Keywords:

  • Neoplasms, Malignant
  • Neoplasms

Name

Location

Sanofi-Aventis Investigational Site Number 840006San Diego, California  92103
Sanofi-Aventis Investigational Site Number 840002San Francisco, California  94115
Sanofi-Aventis Investigational Site Number 840005Decatur, Illinois  62526
Sanofi-Aventis Investigational Site Number 840008Wichita, Kansas  67214
Sanofi-Aventis Investigational Site Number 840010Paducah, Kentucky  42002
Sanofi-Aventis Investigational Site Number 840007Kansas City, Missouri  64128
Sanofi-Aventis Investigational Site Number 840009Bethlehem, Pennsylvania  18015
Sanofi-Aventis Investigational Site Number 840003Salt Lake City, Utah  84132