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

May 4, 2016 updated by: Sanofi

A Randomized, Double-Blind, Placebo-controlled Study Comparing Aflibercept Versus Placebo on the QTc Interval in Cancer Patients Treated With Docetaxel

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients receive background treatment with docetaxel.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Diegem, Belgium
        • Sanofi-Aventis Administrative Office
  • Denmark
      • Horsholm, Denmark
        • Sanofi-Aventis Administrative Office
  • Germany
      • Berlin, Germany
        • Sanofi-Aventis Administrative Office
  • Italy
      • Milano, Italy
        • Sanofi-Aventis Administrative Office
  • Romania
      • Bucuresti, Romania
        • Sanofi-Aventis Administrative Office
  • Turkey
      • Istanbul, Turkey
        • Sanofi-Aventis Administrative Office
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
matching placebo
Drug: placebo
Intravenous route
Experimental: 1
4 mg/kg every 2 weeks
Drug: aflibercept (AVE0005)
Intravenous route

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ECG parameters (QTcF interval)
Time Frame: Cycle 1 and Cycle 3
Cycle 1 and Cycle 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Other ECG parameters
Time Frame: Cycle 1 and Cycle 3
Cycle 1 and Cycle 3
Clinical safety (adverse events, serious adverse events)
Time Frame: maximum of 15 cycles
maximum of 15 cycles
Pharmacokinetic parameters
Time Frame: Cycle 1 and Cycle 3
Cycle 1 and Cycle 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

April 3, 2009

First Posted (Estimate)

April 6, 2009

Study Record Updates

Last Update Posted (Estimate)

May 5, 2016

Last Update Submitted That Met QC Criteria

May 4, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TES10897
  • EudraCT:2008-006796-80

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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