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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1 cancer

Timeline

Completed

Started Apr 2009

Shorter than P25 for phase_1 cancer

Geographic Reach

7 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

April 1, 2009

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2009

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed

Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

10 months

First QC Date

April 3, 2009

Last Update Submit

May 4, 2016

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

ECG parameters (QTcF interval)
Cycle 1 and Cycle 3

Secondary Outcomes (3)

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

Study Arms (2)

1

EXPERIMENTAL

4 mg/kg every 2 weeks

Drug: aflibercept (AVE0005)

2

PLACEBO COMPARATOR

matching placebo

Drug: placebo

Interventions

aflibercept (AVE0005)DRUG

Intravenous route

placeboDRUG

Intravenous route

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.