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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00851084




Registration number
NCT00851084
Ethics application status
Date submitted
24/02/2009
Date registered
25/02/2009
Date last updated
7/06/2016

Titles & IDs
Public title
Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
Scientific title
Randomized, Multinational, Study Of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
Secondary ID [1] 0 0
EudraCT 2008-004178-41
Secondary ID [2] 0 0
EFC10668
Universal Trial Number (UTN)
Trial acronym
AFFIRM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Neoplasms 0 0
Neoplasm Metastasis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - aflibercept
Treatment: Drugs - oxaliplatin
Treatment: Drugs - 5-FU
Treatment: Drugs - Folinic Acid

Active comparator: mFOLFOX6 only - modified FOLFOX6 chemotherapy regimen

Experimental: mFOLFOX6 + aflibercept - modified FOLFOX6 chemotherapy regimen in combination with aflibercept


Treatment: Drugs: aflibercept
administration: IV infusion

Treatment: Drugs: oxaliplatin
administration: IV infusion

Treatment: Drugs: 5-FU
administration: IV infusion

Treatment: Drugs: Folinic Acid
administration: IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) Rate at 12 Months
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)
Secondary outcome [2] 0 0
Overall Objective Response Rate (ORR)
Timepoint [2] 0 0
From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)
Secondary outcome [4] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Timepoint [4] 0 0
From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized
Secondary outcome [5] 0 0
Immunogenicity of Intravenous (IV) Aflibercept
Timepoint [5] 0 0
Any time post baseline and 90 days after the last infusion of aflibercept, according to baseline status

Eligibility
Key inclusion criteria
* Histologically proven adenocarcinoma of the colon or the rectum
* Metastatic disease not amenable to potentially curative treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior therapy for metastatic cancer of the colon or the rectum
* Prior treatment with angiogenesis inhibitors

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
268
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Investigational Site Number 036004 - Douglas
Recruitment hospital [2] 0 0
Sanofi-Aventis Investigational Site Number 036001 - Hunter Region Mail Centre
Recruitment hospital [3] 0 0
Sanofi-Aventis Investigational Site Number 036003 - Hunter Region Mail Centre
Recruitment postcode(s) [1] 0 0
4814 - Douglas
Recruitment postcode(s) [2] 0 0
2310 - Hunter Region Mail Centre
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Berlin
Country [2] 0 0
Germany
State/province [2] 0 0
Dresden
Country [3] 0 0
Germany
State/province [3] 0 0
Hannover
Country [4] 0 0
Germany
State/province [4] 0 0
Homberg
Country [5] 0 0
Germany
State/province [5] 0 0
Mannheim
Country [6] 0 0
Germany
State/province [6] 0 0
Münster
Country [7] 0 0
Germany
State/province [7] 0 0
Recklinghausen
Country [8] 0 0
Italy
State/province [8] 0 0
Bari
Country [9] 0 0
Italy
State/province [9] 0 0
Firenze
Country [10] 0 0
Italy
State/province [10] 0 0
Milano
Country [11] 0 0
Italy
State/province [11] 0 0
Taormina
Country [12] 0 0
Italy
State/province [12] 0 0
Torino
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Busan
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Cheongju
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Daegu
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Daejeon
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Goyang-Si, Gyeonggi-Do
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Ulsan
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Pyatigorsk
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Saint-Petersburg
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Sochi
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Spain
State/province [25] 0 0
Sabadell
Country [26] 0 0
Spain
State/province [26] 0 0
Santiago De Compostela
Country [27] 0 0
Spain
State/province [27] 0 0
Valencia
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Leeds
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Leicester
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Manchester
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Slough
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Zalcberg, MD
Address 0 0
Peter Mc Callum Cancer Centre, Melbourne, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Folprecht G, Pericay C, Saunders MP, Thomas A, Lop... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00851084