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

Cancer Clinical Trial

— QUTIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876044
• Other study ID #: TES10897
• Secondary ID: EudraCT:2008-006
• Status: Completed
• Phase: Phase 1
• First received: April 3, 2009
• Last updated: May 4, 2016
• Start date: April 2009
• Est. completion date: November 2010

Study information

• Verified date: May 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

All patients receive background treatment with docetaxel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• aflibercept (AVE0005)
Intravenous route
• placebo
Intravenous route

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Administrative Office	Diegem
Denmark	Sanofi-Aventis Administrative Office	Horsholm
Germany	Sanofi-Aventis Administrative Office	Berlin
Italy	Sanofi-Aventis Administrative Office	Milano
Romania	Sanofi-Aventis Administrative Office	Bucuresti
Turkey	Sanofi-Aventis Administrative Office	Istanbul
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  Germany,  Italy,  Romania,  Turkey, 

References & Publications (1)

Maison-Blanche P, Vermorken JB, Goksel T, Machiels JP, Agarwala S, Rottey S, Daugaard G, Volovat C, Scheulen M, Sengeløv L, Grecea D, Eniu A, Jäger E, Meiri E, Cascinu S, Strumberg D, Demir G, Clemens M, Pinotti G, Nardi M, Guthrie T, Boelle E, Magherini — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECG parameters (QTcF interval)		Cycle 1 and Cycle 3	No
Secondary	Other ECG parameters		Cycle 1 and Cycle 3	No
Secondary	Clinical safety (adverse events, serious adverse events)		maximum of 15 cycles	No
Secondary	Pharmacokinetic parameters		Cycle 1 and Cycle 3	No