A Study to Evaluate the Effects of Aflibercept on QTc Interval in Cancer Patients



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/6/2016
Start Date:April 2009
End Date:November 2010

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Double-Blind, Placebo-controlled Study Comparing Aflibercept Versus Placebo on the QTc Interval in Cancer Patients Treated With Docetaxel

The primary objective of this study is to evaluate the effects of aflibercept on the QTc
interval in cancer patients.

Secondary objectives are to evaluate the effects of aflibercept on other electrocardiogram
(ECG) parameters, clinical safety and pharmakokinetic (PK) parameters.

All patients receive background treatment with docetaxel.

Inclusion criteria:

- Solid malignancy, documented by pathologic report, for which treatment with
single-agent docetaxel (administered every 3 weeks, at dose <75 mg/m2)is planned.

- Written informed consent

Exclusion criteria:

- Patient has received more than 2 prior lines of cytotoxic-containing chemotherapy

- 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 ECG

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
We found this trial at
2
sites
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey
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Bridgewater, NJ
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Sanofi-Aventis Administrative Office
Diegem,
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Diegem,
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