Status:
COMPLETED
A Study to Evaluate the Effects of Aflibercept on QTc Interval in Cancer Patients
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 electroc...
Detailed Description
All patients receive background treatment with docetaxel.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00876044
Start Date
April 1 2009
End Date
November 1 2010
Last Update
May 5 2016
Active Locations (7)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Diegem, Belgium
3
Sanofi-Aventis Administrative Office
Hørsholm, Denmark
4
Sanofi-Aventis Administrative Office
Berlin, Germany