A Randomized, Double-Blind, Placebo-controlled Study Comparing Aflibercept Versus Placebo on the QTc Interval in Cancer Patients Treated With Docetaxel
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancer
Both
Cancer
Trial Information
A Randomized, Double-Blind, Placebo-controlled Study Comparing Aflibercept Versus Placebo on the QTc Interval in Cancer Patients Treated With Docetaxel
All patients receive background treatment with docetaxel.
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
ECG parameters (QTcF interval)
Outcome Time Frame:
Cycle 1 and Cycle 3
Safety Issue:
No
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
United States: Food and Drug Administration
Study ID:
TES10897
NCT ID:
NCT00876044
Start Date:
April 2009
Completion Date:
November 2010
Related Keywords:
- Cancer
Name | Location |
|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater, New Jersey 08807 |
