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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-11-30

Brief Summary

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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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Detailed Description

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All patients receive background treatment with docetaxel.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

4 mg/kg every 2 weeks

Group Type EXPERIMENTAL

aflibercept (AVE0005)

Intervention Type DRUG

Intravenous route

2

matching placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Intravenous route

Interventions

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aflibercept (AVE0005)

Intravenous route

Intervention Type DRUG

placebo

Intravenous route

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No