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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
The primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study.

Secondary objectives include the evaluation of overall objective response rate to treatment, progression-free survival, overall survival, safety and documentation of potential immunogenicity of aflibercept.

This study was a non-comparative randomized trial and was not powered for a comparison of any of the efficacy endpoints.

Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a check on the similarity of the current patients to the historical controls with respect to clinical outcome when given FOLFOX6 treatment.
Trial website
https://clinicaltrials.gov/study/NCT00851084
Trial related presentations / publications
Folprecht G, Pericay C, Saunders MP, Thomas A, Lopez Lopez R, Roh JK, Chistyakov V, Hohler T, Kim JS, Hofheinz RD, Ackland SP, Swinson D, Kopp M, Udovitsa D, Hall M, Iveson T, Vogel A, Zalcberg JR. Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with or without aflibercept in first-line treatment of patients with metastatic colorectal cancer: the AFFIRM study. Ann Oncol. 2016 Jul;27(7):1273-9. doi: 10.1093/annonc/mdw176. Epub 2016 Apr 18.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00851084