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

Part of paid clinical trials in Bridgewater, New Jersey.

Sponsor
Sanofi
Study ID
NCT00876044
Phase
PHASE1
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 30, 2009
Status verified
May 2016
Primary completion
Feb 28, 2010
Completion
Nov 30, 2010

Study Design

Enrollment
88 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    4 mg/kg every 2 weeks
  • Placebo Comparator: 2
    matching placebo

Primary Outcome Measure

ECG parameters (QTcF interval) [ Time Frame: Cycle 1 and Cycle 3 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sanofi-Aventis Administrative OfficeBridgewaterNew Jersey08807-

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Sanofi-Aventis Administrative Office· Bridgewater, NJ

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