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

NCT00876044 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2016-05-05

No results posted yet for this study

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 electrocardiogram (ECG) parameters, clinical safety and pharmakokinetic (PK) parameters.

Conditions

Interventions

DRUG

aflibercept (AVE0005)

Intravenous route

DRUG

placebo

Intravenous route

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-02-28
Completion
2010-11-30

Countries

  • United States
  • Belgium
  • Denmark
  • Germany
  • Italy
  • Romania
  • Turkey (Türkiye)

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00876044 on ClinicalTrials.gov