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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
Not Enrolling
Both
Cancer

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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 OfficeBridgewater, New Jersey  08807