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Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen (VELOUR)

Primary Purpose

Colorectal Neoplasms, Neoplasm Metastasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring colorectal cancer, metastatic, anti-angiogenic, irinotecan, 5-FU, FOLFIRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Participants who met the following main selection criteria were included in the study.

Inclusion Criteria:

Histologically or cytologically proven adenocarcinoma of the colon or rectum
Metastatic disease that is not amenable to potentially curative treatment
One and only one prior line of treatment for metastatic disease. This prior line should be an oxaliplatin based chemotherapy (participants who relapse within 6 months of completion of oxaliplatin based adjuvant chemotherapy are eligible)
Prior treatment with bevacizumab is permitted.

Exclusion Criteria:

Prior therapy with irinotecan
Eastern Cooperative Oncology Group performance status >2

The above information is not intended to contain all considerations relevant to participation in a clinical trial.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo/FOLFIRI

Aflibercept/FOLFIRI

Arm Description

Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) starting on Day 1 of a 2-week cycle until a treatment discontinuation criterion was met

Participants with Metastatic Colorectal Cancer administered Aflibercept followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) starting on Day 1 of a 2-week cycle until a treatment discontinuation criterion was met

Outcomes

Primary Outcome Measures

Overall Survival (OS)

Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011). OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.

Secondary Outcome Measures

Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)

PFS was the time interval from the date of randomization to the date of progression, or death from any cause if it occurs before tumor progression is documented. To evaluate disease progression, copies of all tumor imaging sets were systematically collected and assessed by the IRC. PFS was analyzed using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model. The analysis for PFS was performed as planned when 561 deaths (OS events) had occurred.

Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria

The overall ORR was the percentage of evaluable participants who achieved complete response [CR] or partial response [PR] according to RECIST criteria version 1.0. CR reflected the disappearance of all tumor lesions (with no new tumors) PR reflected a pre-defined reduction in tumor burden Tumors were assessed by the IRC using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 - 6 weeks.

Number of Participants With Adverse Events (AE)

All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.

Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay

Serum samples for immunogenicity assessment were analyzed using a bridging immunoassay to detect ADA. Positive samples in the ADA assay were further analyzed in the NAb assay using a validated, non-quantitative ligand binding assay.

Full Information

NCT ID

NCT00561470

First Posted

November 20, 2007

Last Updated

September 27, 2012

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals, NSABP Foundation Inc

1. Study Identification

Unique Protocol Identification Number

NCT00561470

Brief Title

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen

Acronym

VELOUR

Official Title

A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan / 5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals, NSABP Foundation Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease. The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.

Detailed Description

Participants were randomized at baseline (treatment was initiated with 3 days of randomization) administered treatment in cycles of 14-days till a study withdrawal criterion was met followed up 30 days after discontinuation of treatment, and every 8 weeks until death or end of study. The criteria for discontinuation of study treatment for a participant are: participant (or legal representative) chose to withdraw from treatment the investigator thought that continuation of the study would be detrimental to the participants well-being due to disease progression unacceptable AEs intercurrent illnesses non-compliance to the study protocol participant was lost to follow-up participant was unblinded for the investigational treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms, Neoplasm Metastasis

Keywords

colorectal cancer, metastatic, anti-angiogenic, irinotecan, 5-FU, FOLFIRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1226 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo/FOLFIRI

Arm Type

Placebo Comparator

Arm Description

Arm Title

Aflibercept/FOLFIRI

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

4 mg/kg of sterile aqueous buffered vehicle (pH 6.0) was administered intra venously (IV) over 1 hour on Day 1, every 2 weeks

Intervention Type

Drug

Intervention Name(s)

Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

Intervention Description

4 mg/kg of Aflibercept was administered IV over 1 hour on Day 1, every 2 weeks.

Intervention Type

Drug

Intervention Name(s)

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

Intervention Description

The FOLFIRI regimen was initiated immediately after Placebo administration on Day 1 The FOLFIRI regimen included: 180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by: 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by: 5-FU 2400 mg/m² continuous IV infusion over 46-hours

Intervention Type

Drug

Intervention Name(s)

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

Intervention Description

The FOLFIRI regimen was initiated immediately after Aflibercept administration on Day 1 The FOLFIRI regimen included: 180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by: 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by: 5-FU 2400 mg/m² continuous IV infusion over 46-hours

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)

Secondary Outcome Measure Information:

Title

Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)

Description

Time Frame

From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)

Title

Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria

Description

Time Frame

From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months)

Title

Number of Participants With Adverse Events (AE)

Description

Time Frame

From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized

Title

Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay

Description

Time Frame

Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Participants who met the following main selection criteria were included in the study. Inclusion Criteria: Histologically or cytologically proven adenocarcinoma of the colon or rectum Metastatic disease that is not amenable to potentially curative treatment One and only one prior line of treatment for metastatic disease. This prior line should be an oxaliplatin based chemotherapy (participants who relapse within 6 months of completion of oxaliplatin based adjuvant chemotherapy are eligible) Prior treatment with bevacizumab is permitted. Exclusion Criteria: Prior therapy with irinotecan Eastern Cooperative Oncology Group performance status >2 The above information is not intended to contain all considerations relevant to participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Investigational Site Number 840119

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35203

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840074

City

Muscle Shoals

State/Province

Alabama

ZIP/Postal Code

35661

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840093

City

Hot Springs

State/Province

Arizona

ZIP/Postal Code

71913

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840080

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840076

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840120

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840073

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904-2007

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840101

City

Hayward

State/Province

California

ZIP/Postal Code

94545

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840046

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840116

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840048

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840201

City

Oakland

State/Province

California

ZIP/Postal Code

94611

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840901

City

Roseville

State/Province

California

ZIP/Postal Code

95678

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840042

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840301

City

Sacramento

State/Province

California

ZIP/Postal Code

95825

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840112

City

Salinas

State/Province

California

ZIP/Postal Code

93901-3906

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840006

City

San Diego

State/Province

California

ZIP/Postal Code

92102

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840106

City

San Diego

State/Province

California

ZIP/Postal Code

92102

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840206

City

San Diego

State/Province

California

ZIP/Postal Code

92102

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840306

City

San Diego

State/Province

California

ZIP/Postal Code

92102

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840406

City

San Diego

State/Province

California

ZIP/Postal Code

92102

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840506

City

San Diego

State/Province

California

ZIP/Postal Code

92102

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840606

City

San Diego

State/Province

California

ZIP/Postal Code

92102

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840706

City

San Diego

State/Province

California

ZIP/Postal Code

92102

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840806

City

San Diego

State/Province

California

ZIP/Postal Code

92102

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840906

City

San Diego

State/Province

California

ZIP/Postal Code

92102

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840401

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840601

City

San Jose

State/Province

California

ZIP/Postal Code

95119

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840501

City

Santa Clara

State/Province

California

ZIP/Postal Code

95051

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840801

City

South San Francisco

State/Province

California

ZIP/Postal Code

94080

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840001

City

Vallejo

State/Province

California

ZIP/Postal Code

94589

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840701

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94596

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840071

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06902

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840014

City

Newark

State/Province

Delaware

ZIP/Postal Code

19718

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840089

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33435

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840041

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840031

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840122

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840079

City

The Villages

State/Province

Florida

ZIP/Postal Code

32159

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840087

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60616

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840019

City

Decatur

State/Province

Illinois

ZIP/Postal Code

62526

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840115

City

Elk Grove Village

State/Province

Illinois

ZIP/Postal Code

60007

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840010

City

Naperville

State/Province

Illinois

ZIP/Postal Code

60540

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840113

City

Quincy

State/Province

Illinois

ZIP/Postal Code

62301

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840072

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46254

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840047

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840034

City

Munster

State/Province

Indiana

ZIP/Postal Code

46321

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840088

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840096

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42003

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840043

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840084

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840015

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840070

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840029

City

Salisbury

State/Province

Maryland

ZIP/Postal Code

21801

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840053

City

Pontiac

State/Province

Michigan

ZIP/Postal Code

48341

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840021

City

St Louis Park

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840081

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64128

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840052

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840114

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63136

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840049

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840044

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840036

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840094

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840017

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840097

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840035

City

Burlington

State/Province

North Carolina

ZIP/Postal Code

27215

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840024

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840026

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28262

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840005

City

Goldsboro

State/Province

North Carolina

ZIP/Postal Code

27534

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840004

City

Hendersonville

State/Province

North Carolina

ZIP/Postal Code

28791

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840075

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840098

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840011

City

Kettering

State/Province

Ohio

ZIP/Postal Code

45429

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840086

City

Middletown

State/Province

Ohio

ZIP/Postal Code

45042

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840008

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43623

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840039

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840118

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840033

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840012

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840082

City

Pawtucket

State/Province

Rhode Island

ZIP/Postal Code

02860

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840095

City

Woonsocket

State/Province

Rhode Island

ZIP/Postal Code

02895

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840085

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29403

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840037

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840078

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78405

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840117

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840099

City

Seattle

State/Province

Washington

ZIP/Postal Code

98115

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840002

City

Marshfield

State/Province

Wisconsin

ZIP/Postal Code

54449

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 032003

City

Bahia Blanca

ZIP/Postal Code

8000

Country

Argentina

Facility Name

Sanofi-Aventis Investigational Site Number 032006

City

Buenos Aires

ZIP/Postal Code

1426ANZ

Country

Argentina

Facility Name

Sanofi-Aventis Investigational Site Number 032005

City

Ciudad De Buenos Aires

ZIP/Postal Code

C1426BOR

Country

Argentina

Facility Name

Sanofi-Aventis Investigational Site Number 032007

City

Salta

ZIP/Postal Code

4400

Country

Argentina

Facility Name

Sanofi-Aventis Investigational Site Number 036004

City

Hornsby

ZIP/Postal Code

2077

Country

Australia

Facility Name

Sanofi-Aventis Investigational Site Number 036001

City

Kingswood

ZIP/Postal Code

2747

Country

Australia

Facility Name

Sanofi-Aventis Investigational Site Number 036002

City

Kurralta Park

ZIP/Postal Code

5037

Country

Australia

Facility Name

Sanofi-Aventis Investigational Site Number 036005

City

Melbourne

ZIP/Postal Code

3050

Country

Australia

Facility Name

Sanofi-Aventis Investigational Site Number 036003

City

Melbourne

ZIP/Postal Code

3128

Country

Australia

Facility Name

Sanofi-Aventis Investigational Site Number 036007

City

Nedlands

ZIP/Postal Code

6009

Country

Australia

Facility Name

Sanofi-Aventis Investigational Site Number 036006

City

Subiaco

ZIP/Postal Code

6008

Country

Australia

Facility Name

Sanofi-Aventis Investigational Site Number 040001

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Sanofi-Aventis Investigational Site Number 056006

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

Sanofi-Aventis Investigational Site Number 056007

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Sanofi-Aventis Investigational Site Number 056002

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Sanofi-Aventis Investigational Site Number 056004

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Sanofi-Aventis Investigational Site Number 056001

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Sanofi-Aventis Investigational Site Number 056005

City

Haine-Saint-Paul

ZIP/Postal Code

7100

Country

Belgium

Facility Name

Sanofi-Aventis Investigational Site Number 056003

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Sanofi-Aventis Investigational Site Number 076004

City

Porto Alegre

ZIP/Postal Code

90035-003

Country

Brazil

Facility Name

Sanofi-Aventis Investigational Site Number 076005

City

Porto Alegre

ZIP/Postal Code

90110-270

Country

Brazil

Facility Name

Sanofi-Aventis Investigational Site Number 076002

City

Porto Alegre

ZIP/Postal Code

90430090

Country

Brazil

Facility Name

Sanofi-Aventis Investigational Site Number 076008

City

Rio De Janeiro

ZIP/Postal Code

20231-050

Country

Brazil

Facility Name

Sanofi-Aventis Investigational Site Number 076003

City

Rio De Janeiro

ZIP/Postal Code

22260-020

Country

Brazil

Facility Name

Sanofi-Aventis Investigational Site Number 076001

City

Santo Andre

ZIP/Postal Code

09050-360

Country

Brazil

Facility Name

Sanofi-Aventis Investigational Site Number 076007

City

Sao Paulo

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Sanofi-Aventis Investigational Site Number 076006

City

Sao Paulo

ZIP/Postal Code

01308050

Country

Brazil

Facility Name

Sanofi-Aventis Investigational Site Number 152002

City

Santiago

ZIP/Postal Code

7510032

Country

Chile

Facility Name

Sanofi-Aventis Investigational Site Number 152003

City

Santiago

ZIP/Postal Code

7650635

Country

Chile

Facility Name

Sanofi-Aventis Investigational Site Number 152001

City

Santiago

ZIP/Postal Code

8380455

Country

Chile

Facility Name

Sanofi-Aventis Investigational Site Number 152005

City

Santiago

ZIP/Postal Code

8380456

Country

Chile

Facility Name

Sanofi-Aventis Investigational Site Number 152004

City

Viña Del Mar

ZIP/Postal Code

2540364

Country

Chile

Facility Name

Sanofi-Aventis Investigational Site Number 203002

City

Brno

ZIP/Postal Code

62500

Country

Czech Republic

Facility Name

Sanofi-Aventis Investigational Site Number 203001

City

Brno

ZIP/Postal Code

65653

Country

Czech Republic

Facility Name

Sanofi-Aventis Investigational Site Number 203004

City

Praha 5

ZIP/Postal Code

15006

Country

Czech Republic

Facility Name

Sanofi-Aventis Investigational Site Number 208001

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Sanofi-Aventis Investigational Site Number 208003

City

Ålborg

ZIP/Postal Code

9100

Country

Denmark

Facility Name

Sanofi-Aventis Investigational Site Number 233002

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Sanofi-Aventis Investigational Site Number 233001

City

Tartu

ZIP/Postal Code

50406

Country

Estonia

Facility Name

Sanofi-Aventis Investigational Site Number 250002

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 250004

City

Clichy Cx

ZIP/Postal Code

92118

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 250005

City

La Roche Sur Yon

ZIP/Postal Code

85925

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 250001

City

Lyon Cedex 03

ZIP/Postal Code

69437

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 250003

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 276003

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276002

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276001

City

Halle / Saale

ZIP/Postal Code

06120

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276005

City

Magdeburg

ZIP/Postal Code

39104

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276004

City

Magdeburg

ZIP/Postal Code

39130

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276006

City

München

ZIP/Postal Code

81737

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 300005

City

Athens

ZIP/Postal Code

11522

Country

Greece

Facility Name

Sanofi-Aventis Investigational Site Number 300004

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Sanofi-Aventis Investigational Site Number 300001

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

Sanofi-Aventis Investigational Site Number 300002

City

Ilion, Athens

Country

Greece

Facility Name

Sanofi-Aventis Investigational Site Number 300003

City

Patras

ZIP/Postal Code

26500

Country

Greece

Facility Name

Sanofi-Aventis Investigational Site Number 380007

City

Ancona

ZIP/Postal Code

60032

Country

Italy

Facility Name

Sanofi-Aventis Investigational Site Number 380005

City

Aviano

ZIP/Postal Code

33081

Country

Italy

Facility Name

Sanofi-Aventis Investigational Site Number 380004

City

Candiolo

ZIP/Postal Code

10060

Country

Italy

Facility Name

Sanofi-Aventis Investigational Site Number 380003

City

Genova

ZIP/Postal Code

16128

Country

Italy

Facility Name

Sanofi-Aventis Investigational Site Number 380001

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Sanofi-Aventis Investigational Site Number 380002

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Sanofi-Aventis Investigational Site Number 380008

City

Rozzano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Sanofi-Aventis Investigational Site Number 380006

City

San Giovanni Rotondo

ZIP/Postal Code

71013

Country

Italy

Facility Name

Sanofi-Aventis Investigational Site Number 410001

City

Goyang

ZIP/Postal Code

410-760

Country

Korea, Republic of

Facility Name

Sanofi-Aventis Investigational Site Number 410003

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Sanofi-Aventis Investigational Site Number 410005

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Sanofi-Aventis Investigational Site Number 410002

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Sanofi-Aventis Investigational Site Number 410004

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Sanofi-Aventis Investigational Site Number 528004

City

Amsterdam

ZIP/Postal Code

1091 HA

Country

Netherlands

Facility Name

Sanofi-Aventis Investigational Site Number 528001

City

Blaricum

ZIP/Postal Code

1261 AN

Country

Netherlands

Facility Name

Sanofi-Aventis Investigational Site Number 528005

City

Breda

ZIP/Postal Code

4819 EV

Country

Netherlands

Facility Name

Sanofi-Aventis Investigational Site Number 528002

City

Rotterdam

ZIP/Postal Code

3007 AC

Country

Netherlands

Facility Name

Sanofi-Aventis Investigational Site Number 528003

City

Sittard-Geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

Sanofi-Aventis Investigational Site Number 554009

City

Auckland

ZIP/Postal Code

1023

Country

New Zealand

Facility Name

Sanofi-Aventis Investigational Site Number 554010

City

Christchurch

Country

New Zealand

Facility Name

Sanofi-Aventis Investigational Site Number 578002

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Facility Name

Sanofi-Aventis Investigational Site Number 578001

City

Oslo

ZIP/Postal Code

0407

Country

Norway

Facility Name

Sanofi-Aventis Investigational Site Number 578003

City

Stavanger

ZIP/Postal Code

4011

Country

Norway

Facility Name

Sanofi-Aventis Investigational Site Number 616005

City

Czestochowa

ZIP/Postal Code

42-200

Country

Poland

Facility Name

Sanofi-Aventis Investigational Site Number 616004

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Sanofi-Aventis Investigational Site Number 616007

City

Krakow

ZIP/Postal Code

31-826

Country

Poland

Facility Name

Sanofi-Aventis Investigational Site Number 616003

City

Lodz

ZIP/Postal Code

93-509

Country

Poland

Facility Name

Sanofi-Aventis Investigational Site Number 616002

City

Poznan

ZIP/Postal Code

61-485

Country

Poland

Facility Name

Sanofi-Aventis Investigational Site Number 616006

City

Rybnik

ZIP/Postal Code

44-200

Country

Poland

Facility Name

Sanofi-Aventis Investigational Site Number 616001

City

Wroclaw

ZIP/Postal Code

53-413

Country

Poland

Facility Name

Sanofi-Aventis Investigational Site Number 630001

City

San Juan

ZIP/Postal Code

00927

Country

Puerto Rico

Facility Name

Sanofi-Aventis Investigational Site Number 642004

City

Alba Iulia

ZIP/Postal Code

510077

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642007

City

Bucharest

ZIP/Postal Code

050098

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642001

City

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642002

City

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642003

City

Cluj Napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642006

City

Iasi

ZIP/Postal Code

700106

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642005

City

Suceava

ZIP/Postal Code

720237

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 643001

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Sanofi-Aventis Investigational Site Number 643006

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Sanofi-Aventis Investigational Site Number 643002

City

Moscow

ZIP/Postal Code

129128

Country

Russian Federation

Facility Name

Sanofi-Aventis Investigational Site Number 643003

City

Saint-Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Sanofi-Aventis Investigational Site Number 643004

City

St-Petersburg

ZIP/Postal Code

191104

Country

Russian Federation

Facility Name

Sanofi-Aventis Investigational Site Number 643007

City

St-Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Sanofi-Aventis Investigational Site Number 710004

City

Cape Town

ZIP/Postal Code

7506

Country

South Africa

Facility Name

Sanofi-Aventis Investigational Site Number 710005

City

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Sanofi-Aventis Investigational Site Number 710008

City

Durban

ZIP/Postal Code

4062

Country

South Africa

Facility Name

Sanofi-Aventis Investigational Site Number 710001

City

Parktown

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Sanofi-Aventis Investigational Site Number 710006

City

Port Elizabeth

ZIP/Postal Code

6001

Country

South Africa

Facility Name

Sanofi-Aventis Investigational Site Number 710007

City

Pretoria

ZIP/Postal Code

0001

Country

South Africa

Facility Name

Sanofi-Aventis Investigational Site Number 710003

City

Pretoria

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Sanofi-Aventis Investigational Site Number 724002

City

Barakaldo

ZIP/Postal Code

48903

Country

Spain

Facility Name

Sanofi-Aventis Investigational Site Number 724005

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Sanofi-Aventis Investigational Site Number 724001

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Sanofi-Aventis Investigational Site Number 724006

City

Madrid

ZIP/Postal Code

28035

Country

Spain

Facility Name

Sanofi-Aventis Investigational Site Number 724003

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Sanofi-Aventis Investigational Site Number 724007

City

Reus

ZIP/Postal Code

43201

Country

Spain

Facility Name

Sanofi-Aventis Investigational Site Number 752002

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Sanofi-Aventis Investigational Site Number 752003

City

Sundsvall

ZIP/Postal Code

851 86

Country

Sweden

Facility Name

Sanofi-Aventis Investigational Site Number 752001

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Sanofi-Aventis Investigational Site Number 792005

City

Adana

ZIP/Postal Code

01120

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 792004

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 792001

City

Ankara

ZIP/Postal Code

06500

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 792002

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 792003

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 804005

City

Dnipropetrovsk

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804004

City

Donetsk

ZIP/Postal Code

83092

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804006

City

Kharkiv

ZIP/Postal Code

61037

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804002

City

Kharkov

ZIP/Postal Code

61070

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 826001

City

Aberdeen

ZIP/Postal Code

AB25 2ZD

Country

United Kingdom

Facility Name

Sanofi-Aventis Investigational Site Number 826010

City

Bournemouth

ZIP/Postal Code

BH7 7DW

Country

United Kingdom

Facility Name

Sanofi-Aventis Investigational Site Number 826009

City

Dudley

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

Facility Name

Sanofi-Aventis Investigational Site Number 826008

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Sanofi-Aventis Investigational Site Number 826004

City

London

ZIP/Postal Code

N18 1QX

Country

United Kingdom

Facility Name

Sanofi-Aventis Investigational Site Number 826007

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

Sanofi-Aventis Investigational Site Number 826011

City

London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Sanofi-Aventis Investigational Site Number 826002

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Sanofi-Aventis Investigational Site Number 826003

City

Northwood

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Sanofi-Aventis Investigational Site Number 826005

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

34789774

Citation

Lu L, Dercle L, Zhao B, Schwartz LH. Deep learning for the prediction of early on-treatment response in metastatic colorectal cancer from serial medical imaging. Nat Commun. 2021 Nov 17;12(1):6654. doi: 10.1038/s41467-021-26990-6.

Results Reference

derived

PubMed Identifier

32168980

Citation

Chau I, Fakih M, Garcia-Alfonso P, Linke Z, Ruiz Casado A, Marques EP, Picard P, Celanovic M, Cartwright T. Safety and Effectiveness of Aflibercept + Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) for the Treatment of Patients with Metastatic Colorectal Cancer (mCRC) in Current Clinical Practice: OZONE Study. Cancers (Basel). 2020 Mar 11;12(3):657. doi: 10.3390/cancers12030657.

Results Reference

derived

PubMed Identifier

28807738

Citation

Ruff P, Van Cutsem E, Lakomy R, Prausova J, van Hazel GA, Moiseyenko VM, Soussan-Lazard K, Dochy E, Magherini E, Macarulla T, Papamichael D. Observed benefit and safety of aflibercept in elderly patients with metastatic colorectal cancer: An age-based analysis from the randomized placebo-controlled phase III VELOUR trial. J Geriatr Oncol. 2018 Jan;9(1):32-39. doi: 10.1016/j.jgo.2017.07.010. Epub 2017 Aug 12.

Results Reference

derived

PubMed Identifier

28761750

Citation

Stanel SC, Sjoberg J, Salmonson T, Foggi P, Caleno M, Melchiorri D, Gravanis I, Tzogani K, Pignatti F. European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer. ESMO Open. 2017 May 2;2(2):e000190. doi: 10.1136/esmoopen-2017-000190. eCollection 2017.

Results Reference

derived

PubMed Identifier

26706237

Citation

Van Cutsem E, Joulain F, Hoff PM, Mitchell E, Ruff P, Lakomy R, Prausova J, Moiseyenko VM, van Hazel G, Cunningham D, Arnold D, Schmoll HJ, Ten Tije AJ, McKendrick J, Kroning H, Humblet Y, Gravalos C, Le-Guennec S, Andria M, Dochy E, Vishwanath RL, Macarulla T, Tabernero J. Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy. Target Oncol. 2016 Jun;11(3):383-400. doi: 10.1007/s11523-015-0402-9.

Results Reference

derived

PubMed Identifier

24140268

Citation

Tabernero J, Van Cutsem E, Lakomy R, Prausova J, Ruff P, van Hazel GA, Moiseyenko VM, Ferry DR, McKendrick JJ, Soussan-Lazard K, Chevalier S, Allegra CJ. Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial. Eur J Cancer. 2014 Jan;50(2):320-31. doi: 10.1016/j.ejca.2013.09.013. Epub 2013 Oct 16.

Results Reference

derived

PubMed Identifier

22949147

Citation

Van Cutsem E, Tabernero J, Lakomy R, Prenen H, Prausova J, Macarulla T, Ruff P, van Hazel GA, Moiseyenko V, Ferry D, McKendrick J, Polikoff J, Tellier A, Castan R, Allegra C. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol. 2012 Oct 1;30(28):3499-506. doi: 10.1200/JCO.2012.42.8201. Epub 2012 Sep 4.

Results Reference

derived

Learn more about this trial

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen

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Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen (VELOUR)

Colorectal Neoplasms, Neoplasm Metastasis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial