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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: aflibercept (AVE0005); Drug: placebo

• Registration Number: NCT00876044
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

All patients receive background treatment with docetaxel.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-06
• Primary Completion: 2010-02
• Study Completion: 2010-11
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-04
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	aflibercept (AVE0005)	4 mg/kg every 2 weeks
2	placebo	matching placebo

Primary Outcome Measures

Name	Time	Method
ECG parameters (QTcF interval)	Cycle 1 and Cycle 3

Secondary Outcome Measures

Name	Time	Method
Other ECG parameters	Cycle 1 and Cycle 3
Clinical safety (adverse events, serious adverse events)	maximum of 15 cycles
Pharmacokinetic parameters	Cycle 1 and Cycle 3

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇹🇷 Istanbul, Turkey