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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00876044
Recruitment Status : Completed
First Posted : April 6, 2009
Last Update Posted : May 5, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Cancer Drug: aflibercept (AVE0005) Drug: placebo Phase 1

Detailed Description:
All patients receive background treatment with docetaxel.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2009
Primary Completion Date : February 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Aflibercept
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. ECG parameters (QTcF interval) [ Time Frame: Cycle 1 and Cycle 3 ]

Secondary Outcome Measures :
  1. Other ECG parameters [ Time Frame: Cycle 1 and Cycle 3 ]
  2. Clinical safety (adverse events, serious adverse events) [ Time Frame: maximum of 15 cycles ]
  3. Pharmacokinetic parameters [ Time Frame: Cycle 1 and Cycle 3 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876044


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