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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2016
• Main ID: NCT00876044
• Date of registration: 03/04/2009
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: A Study to Evaluate the Effects of Aflibercept on QTc Interval in Cancer Patients QUTIE
• Scientific title: A Randomized, Double-Blind, Placebo-controlled Study Comparing Aflibercept Versus Placebo on the QTc Interval in Cancer Patients Treated With Docetaxel
• Date of first enrolment: April 2009
• Target sample size: 88
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00876044
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

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

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cancer

Intervention(s)

Drug: aflibercept (AVE0005)

Drug: placebo

Primary Outcome(s)

ECG parameters (QTcF interval) [Time Frame: Cycle 1 and Cycle 3]

Secondary Outcome(s)

Pharmacokinetic parameters [Time Frame: Cycle 1 and Cycle 3]

Clinical safety (adverse events, serious adverse events) [Time Frame: maximum of 15 cycles]

Other ECG parameters [Time Frame: Cycle 1 and Cycle 3]

Secondary ID(s)

TES10897

EudraCT:2008-006796-80

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneron Pharmaceuticals