A Study to Evaluate the Effects of Aflibercept on QTc Int... | NCT00876044

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

NCT00876044

Sponsor

Sanofi

Status

Completed

Last Update Posted

May 5, 2016Estimated

Enrollment

88Actual

Phase

Phase 1

Conditions

Cancer

Interventions

aflibercept (AVE0005)
placebo

Countries

United States
Belgium
Denmark
Germany
Italy
Romania
Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT:2008-006796-80

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Apr 3, 2009

First Submission Date that Met QC Criteria

Apr 3, 2009

First Posted Date

Apr 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2016

Last Update Posted Date

May 5, 2016Estimated

Name	Class
Regeneron Pharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	4 mg/kg every 2 weeks	Drug: aflibercept (AVE0005)
2	Placebo Comparator	matching placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aflibercept (AVE0005)	Drug	Intravenous route	1
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ECG parameters (QTcF interval)		Cycle 1 and Cycle 3

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Bridgewater	New Jersey	08807	United States
Sanofi-Aventis Administrative Office

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23429593	Result	Maison-Blanche P, Vermorken JB, Goksel T, Machiels JP, Agarwala S, Rottey S, Daugaard G, Volovat C, Scheulen M, Sengelov L, Grecea D, Eniu A, Jager E, Meiri E, Cascinu S, Strumberg D, Demir G, Clemens M, Pinotti G, Nardi M, Guthrie T, Boelle E, Magherini E. A randomized, double-blind, placebo-controlled study to assess QTc interval prolongation of standard dose aflibercept in cancer patients treated with docetaxel. J Cardiovasc Pharmacol. 2013 Jun;61(6):495-504. doi: 10.1097/FJC.0b013e31828b73ff.