Effect of Cabazitaxel on the QTc Interval in Cancer Patients

Completed · Phase 1

Conditions studied: Neoplasms, Malignant

In brief

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)

Key facts

Study ID

NCT01087021

Run by

Sanofi

People needed

45

Starts

2010-03-01

Expected to finish

2011-11-01

Last updated by the study team

2011-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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