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Completed

NCT Number: NCT00876044

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sanofi-Aventis Administrative Office, Diegem, Belgium

Loading trial locations.

About this study

All patients receive background treatment with docetaxel.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aflibercept (AVE0005)

Drug

Intravenous route

Placebo

Drug

Intravenous route

Primary outcomes

  1. ECG parameters (QTcF interval)

    Time frame: Cycle 1 and Cycle 3

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Acronym: QUTIE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 6, 2009
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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