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

This study has been completed.
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: April 3, 2009
Last updated: May 4, 2016
Last verified: May 2016

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.

Condition Intervention Phase
Drug: aflibercept (AVE0005)
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-controlled Study Comparing Aflibercept Versus Placebo on the QTc Interval in Cancer Patients Treated With Docetaxel

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • ECG parameters (QTcF interval) [ Time Frame: Cycle 1 and Cycle 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other ECG parameters [ Time Frame: Cycle 1 and Cycle 3 ] [ Designated as safety issue: No ]
  • Clinical safety (adverse events, serious adverse events) [ Time Frame: maximum of 15 cycles ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters [ Time Frame: Cycle 1 and Cycle 3 ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: April 2009
Study Completion Date: November 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
4 mg/kg every 2 weeks
Drug: aflibercept (AVE0005)
Intravenous route
Placebo Comparator: 2
matching placebo
Drug: placebo
Intravenous route

Detailed Description:
All patients receive background treatment with docetaxel.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00876044

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Horsholm, Denmark
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Milano, Italy
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi