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CompletedNCT00876044QUTIEUpdated May 5, 2016

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

A Phase 1 interventional study of aflibercept (AVE0005) and placebo in Cancer, sponsored by Sanofi. Completed at 7 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-05.

Sponsored by Sanofi · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

All patients receive background treatment with docetaxel.

02

Conditions studied

  • Cancer
03

In context

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    1

    4 mg/kg every 2 weeks

    Drug: aflibercept (AVE0005)

  • Placebo comparator
    2

    matching placebo

    Drug: placebo

Interventions

  • Drugaflibercept (AVE0005)

    Intravenous route

  • Drugplacebo

    Intravenous route

06

What researchers measure

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

07

Study locations

7 sites
  • Sanofi-Aventis Administrative Office
    Bridgewater, New Jersey 08807, United States
  • Sanofi-Aventis Administrative Office
    Diegem, Belgium
  • Sanofi-Aventis Administrative Office
    Horsholm, Denmark
  • Sanofi-Aventis Administrative Office
    Berlin, Germany
  • Sanofi-Aventis Administrative Office
    Milano, Italy
  • Sanofi-Aventis Administrative Office
    Bucuresti, Romania
  • Sanofi-Aventis Administrative Office
    Istanbul, Turkey
08

References and documents

Publications

  • Maison-Blanche P, Vermorken JB, Goksel T, Machiels JP, Agarwala S, Rottey S, Daugaard G, Volovat C, Scheulen M, Sengelov L, Grecea D, Eniu A, Jager E, Meiri E, Cascinu S, Strumberg D, Demir G, Clemens M, Pinotti G, Nardi M, Guthrie T, Boelle E, Magherini E. A randomized, double-blind, placebo-controlled study to assess QTc interval prolongation of standard dose aflibercept in cancer patients treated with docetaxel. J Cardiovasc Pharmacol. 2013 Jun;61(6):495-504. doi: 10.1097/FJC.0b013e31828b73ff. PubMed 23429593 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00876044
Lead sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Apr 6, 2009
Start date
Apr 2009
Primary completion
Feb 2010
Completion
Nov 2010
Last update
May 5, 2016

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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