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

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00876044
First received: April 3, 2009
Last updated: December 13, 2011
Last verified: December 2011
  Purpose

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
Cancer
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00876044     History of Changes
Other Study ID Numbers: TES10897, EudraCT:2008-006796-80
Study First Received: April 3, 2009
Last Updated: December 13, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 28, 2014