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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
History of Changes

April 3, 2009
December 13, 2011
April 2009
February 2010   (final data collection date for primary outcome measure)
ECG parameters (QTcF interval) [ Time Frame: Cycle 1 and Cycle 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00876044 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Effects of Aflibercept on QTc Interval in Cancer Patients
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.

All patients receive background treatment with docetaxel.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cancer
  • Drug: aflibercept (AVE0005)
    Intravenous route
  • Drug: placebo
    Intravenous route
  • Experimental: 1
    4 mg/kg every 2 weeks
    Intervention: Drug: aflibercept (AVE0005)
  • Placebo Comparator: 2
    matching placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
November 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Denmark,   Germany,   Italy,   Romania,   Turkey
 
NCT00876044
TES10897, EudraCT:2008-006796-80
No
Sanofi
Sanofi
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP