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Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01571284
Recruitment Status : Completed
First Posted : April 5, 2012
Results First Posted : February 27, 2018
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To provide metastatic colorectal cancer participants with access to aflibercept and to document the overall safety in these participants

Secondary Objective:

To document the Health-Related Quality of Life of aflibercept in this participants population


Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Drug: AFLIBERCEPT AVE0005 Drug: FOLFIRI Phase 3

Detailed Description:
Each participants will be treated until disease progression, unacceptable toxicity, death, Investigator's decision or participant's refusal for further treatment (whichever comes first). Participants were followed-up during study treatment and for at least 30 days after last administration.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 781 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single Arm, Open Label Clinical Trial to Evaluate the Safety and Health-Related Quality of Life of Aflibercept in Patients With Metastatic Colorectal Cancer (mCRC) Previously Treated With an Oxaliplatin-Containing Regimen
Actual Study Start Date : May 30, 2012
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-Fluorouracil (5-FU) 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
Drug: AFLIBERCEPT AVE0005
Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous

Drug: FOLFIRI
irinotecan, 5-FU and leucovorin




Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) ]
    Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. A serious AE (SAE): Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Version 4.03 was used to assess severity (Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling) of AEs.

  2. Number of Participants With Abnormal Hematological Parameters [ Time Frame: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) ]
    Abnormal hematological parameters included: anaemia, thrombocytopenia, leukopenia and neutropenia. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4 as per NCI CTCAE (Version 4.03), where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.

  3. Number of Participants With International Normalized Ratio (INR) [ Time Frame: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) ]
    The INR is a derived measure of the prothrombin time. The INR is the ratio of a participant's prothrombin time to a normal control sample. Normal range (without anti coagulation therapy): 0.8-1.2; Targeted range (with anti coagulation therapy) 2.0-3.0.

  4. Number of Participants With Abnormal Electrolytes Parameters [ Time Frame: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) ]
    Abnormal electrolytes parameters included: hyponatremia, hypernatremia, hypocalcemia, hypercalcemia, hypokalemia, and hyperkalemia. Number of participants with each of these parameters were analyzed by grades ( All Grades and Grades 3-4 as per NCI CTCAE Version 4.03, where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.

  5. Number of Participants With Abnormal Renal and Liver Function Parameters [ Time Frame: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) ]
    Renal and liver function parameters included: creatinine, hyperbilirubinemia, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4) as per NCI CTCAE version 4.03, where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.

  6. Creatinine Clearance of Aflibercept Plus FOLFIRI [ Time Frame: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) ]
    Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance was calculated using the Cockroft-Gault or Modification of Diet in Renal Disease (MDRD).

  7. Number of Participants With Other Abnormal Biochemistry Parameters [ Time Frame: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) ]
    Other abnormal biochemistry parameters included: hypoglycemia, hyperglycemia and hypoalbuminemia. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4) as per NCI CTCAE Version 4.03, where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.

  8. Number of Participants With Abnormal Non-Gradable Biochemistry Parameters [ Time Frame: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) ]
    Non-gradeable biochemistry parameters included; chloride, urea, total protein, blood urea nitrogen (BUN) and lactate dehydrogenase (LDH). Number of participants with <lower limit of normal ranges (LLN) and >upper limit of normal ranges (ULN) for each of these parameters were reported.

  9. Number of Participants With Proteinuria Events [ Time Frame: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) ]
    Proteinuria is defined as the ratio of protein to creatinine. Number of participants with proteinuria were analyzed by grades (Grades 1, 2, 3 ,4) as per NCI CTCAE Version 4.03 where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling.

  10. Number of Participants With Proteinuria Grade >=2 [ Time Frame: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) ]
    Proteinuria is defined as the ratio of protein to creatinine. Number of participants with proteinuria grade >=2 (graded as per NCI CTCAE Version 4.03), where Grade>=2 represents moderate to life-threatening/disabling event.

  11. Number of Participants With Urinary Protein-Creatinine Ratio (UPCR) [ Time Frame: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) ]
    Urinary protein creatinine ratio (UPCR) corresponds to the ratio of the urinary protein and urinary creatinine concentration (expressed in mg/dL). This ratio provides an accurate quantification of 24-hours urinary protein excretion. There is a high correlation between morning UPCR and 24-hour proteinuria in participants with normal or reduced renal functions. Normal ratio is < or = 1.

  12. Number of Participants With Proteinuria (Grade>=2) Concomitant With Hematuria and /or Hypertension [ Time Frame: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) ]
    Proteinuria is defined as the presence of excess proteins in the urine (assessed either by spot sample, dipstick/ urine protein or 24 hour urine collection). Hematuria is defined as the presence of blood in urine (positive dipstick for RBC or reported AE). Number of participants with proteinuria grade >=2 (graded as per NCI CTCAE Version 4.03), where Grade>=2 represents moderate to life-threatening/disabling event. Hypertension (high blood pressure) is defined as having a blood pressure reading of more than 140/90 mmHg over a number of weeks.

  13. Number of Participants With Cycle Delay and/or Dose Modification [ Time Frame: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) ]
    A theoretical cycle is a 2 week period i.e. 14 days. A cycle is delayed if duration of previous cycle is greater than 14+2 days ; dose modification includes dose reduction and dose omission.


Secondary Outcome Measures :
  1. Mean Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30 Score): Global Health Status [ Time Frame: Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at the end of treatment (EOT) (within 30 days of last treatment) (maximum exposure: 214 weeks) ]
    EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) & other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent).EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favourable outcome with a best quality of life for participant.

  2. Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales [ Time Frame: Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 weeks) ]
    EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) & other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28).Answers were converted into grading scale, with values between 0 and 100. A high score represented a favourable outcome with a best quality of life for participant.

  3. Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales [ Time Frame: Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 weeks) ]
    EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) & other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.

  4. Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score [ Time Frame: Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 weeks) ]
    EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems & severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state.

  5. Change From Baseline in HRQL EQ-5D-3L VAS Score [ Time Frame: Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 weeks) ]
    EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and VAS. EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems & severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. The VAS recorded the respondent's self-rated health on a vertical visual analogue scale. The VAS 'thermometer' has endpoints of 100 (Best imaginable health state) at the top and 0 (Worst imaginable health state) at the bottom. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Histologically or cytologically proven adenocarcinoma of the colon or rectum.
  • Metastatic disease.
  • Eastern Cooperative Oncology Group performance status 0-1.
  • One and only one prior chemotherapeutic regimen for metastatic disease. This prior chemotherapy was an oxaliplatin containing regimen. Participants must had progressed during or after the oxaliplatin based chemotherapy. Participants relapsed within 6 months of completion of oxaliplatin adjuvant chemotherapy were eligible.
  • Signed written informed consent obtained prior to inclusion.

Exclusion criteria:

  • Prior therapy with irinotecan.
  • Inadequate bone marrow, liver and renal function: neutrophils < 1.5x109/L, platelets < 100x109/L, hemoglobin < 9.0 g/dL, total bilirubin >1.5 x upper normal limit (ULN), transaminases >3 x ULN (unless liver metastasis are present), alkaline phosphatase >3 x ULN (unless liver metastasis are present), serum creatinine > 1.5 x ULN.
  • Less than 4 weeks from prior radiotherapy, prior chemotherapy, prior major surgery (or until the surgical wound were fully healed).
  • Treatment with any investigational drug within the prior 30 days.
  • Treatment with concomitant anticonvulsivant agents that were CYP3A4 inducers (phenytoin, phenobarbital, carbamazepine), unless discontinued >7 days.
  • History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
  • Prior malignancy (other than colorectal) including prior malignancy from which the participants had been disease free for < 5 years (except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix).
  • Any of the following within 6 months prior to study inclusion: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, severe congestive heart failure, stroke or transient ischemic attack.
  • Any of the following within 3 months prior study inclusion: severe gastrointestinal bleeding/hemorrhage, treatment resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thromboembolic event.
  • Occurrence of deep vein thrombosis within 4 weeks, prior to study inclusion.
  • Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.
  • Known dihydropyrimidine dehydrogenase deficiency.
  • Predisposing colonic or small bowel disorders in which the symptoms were uncontrolled.
  • Prior history of chronic enteropathy, inflammatory enteropathy, chronic diarrhea, unresolved bowel obstruction/sub-obstruction, more than hemicolectomy, extensive small intestine resection with chronic diarrhea.
  • Known Gilbert's syndrome.
  • Unresolved or unstable toxicity from any prior anti cancer therapy at the time of inclusion.
  • History of anaphylaxis or known intolerance to atropine sulphate or loperamide or appropriate antiemetics to be administered in conjunction with FOLFIRI (irinotecan, 5-Fluorouracil, leucovorin).
  • Severe acute or chronic medical condition, which could impair the ability of the participants to participate to the study.
  • Urine protein-creatinine ratio (UPCR) >1 on morning spot urinalysis or proteinuria > 500 mg/24-h.
  • Uncontrolled hypertension within 3 months prior to study inclusion.
  • Participants on anticoagulant therapy with unstable dose of warfarin and/or had an out-of-therapeutic range INR within the 4 weeks prior to study inclusion.
  • Evidence of clinically significant bleeding predisposition or underlying coagulopathy, non-healing wound.
  • Pregnant or breast-feeding women.
  • Participants with reproductive potential who were not agree to use an accepted effective method of contraception.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571284


Locations
Hide Hide 179 study locations
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United States, Alabama
Investigational Site Number 840-002
Muscle Shoals, Alabama, United States, 35661
United States, California
Investigational Site Number 840-008
Corona, California, United States, 92879
Investigational Site Number 840-007
Fountain Valley, California, United States, 92708
Investigational Site Number 840-004
Riverside, California, United States, 92501
United States, Indiana
Investigational Site Number 840-006
Indianapolis, Indiana, United States, 46254
United States, Louisiana
Investigational Site Number 840-011
Metairie, Louisiana, United States, 70006
United States, Maryland
Investigational Site Number 840-001
Rockville, Maryland, United States, 20850
United States, New Jersey
Investigational Site Number 840-010
Howell, New Jersey, United States, 07731
United States, New Mexico
Investigational Site Number 840-012
Albuquerque, New Mexico, United States, 87106
Investigational Site Number 840-009
Farmington, New Mexico, United States, 87401
United States, New York
Investigational Site Number 840-003
Lake Success, New York, United States, 11042
United States, Ohio
Investigational Site Number 840-005
Middletown, Ohio, United States, 45042
Belgium
Investigational Site Number 056010
Aalst, Belgium, 9300
Investigational Site Number 056015
Arlon, Belgium, 6700
Investigational Site Number 056004
Bonheiden, Belgium, 2820
Investigational Site Number 056001
Edegem, Belgium, 2650
Investigational Site Number 056012
Gent, Belgium, 9000
Investigational Site Number 056009
Haine-Saint-Paul, Belgium, 7100
Investigational Site Number 056003
Liège, Belgium, 4000
Investigational Site Number 056007
Liège, Belgium, 4000
Investigational Site Number 056014
Loverval, Belgium, 6280
Investigational Site Number 056013
Turnhout, Belgium, 2300
Investigational Site Number 056002
Verviers, Belgium, 4800
Investigational Site Number 056011
Yvoir, Belgium, 5530
Brazil
Investigational Site Number 008
Brasília, Brazil, 70390-150
Investigational Site Number 009
Curitiba, Brazil, 80530-010
Investigational Site Number 012
Fortaleza, Brazil
Investigational Site Number 006
Passo Fundo, Brazil, 99010-260
Investigational Site Number 003
Porto Alegre, Brazil, 90470-340
Investigational Site Number 002
Rio de Janeiro, Brazil, 22793-080
Investigational Site Number 011
Salvador, Brazil, 40170-070
Investigational Site Number 013
Sao Jose do Rio Preto, Brazil, 15090-000
Investigational Site Number 001
São Paulo, Brazil, 01246-000
Investigational Site Number 004
São Paulo, Brazil, 01308-050
Investigational Site Number 005
São Paulo, Brazil, 01321-000
Canada
Investigational Site Number 124002
Calgary, Canada, T2N 4N2
Investigational Site Number 124003
Montreal, Canada, H1T 2M4
Investigational Site Number 124005
Montreal, Canada, H2W1S6
Investigational Site Number 124004
Ottawa, Canada, K1H8L6
Investigational Site Number 124006
Québec, Canada, G1S4L8
Investigational Site Number 124001
Toronto, Canada, M4N3M5
Chile
Investigational Site Number 152001
Santiago, Chile
Investigational Site Number 152003
Santiago, Chile
Czechia
Investigational Site Number 203005
Brno, Czechia, 65653
Investigational Site Number 203003
Olomouc, Czechia, 77900
Investigational Site Number 203001
Ostrava, Czechia, 70852
Investigational Site Number 203002
Praha 2, Czechia, 12808
Investigational Site Number 203004
Praha 5, Czechia, 15006
Investigational Site Number 203006
Zlin, Czechia
Denmark
Investigational Site Number 208001
Cph Ø, Denmark, 2100
Investigational Site Number 208003
Hillerød, Denmark, 3400
Investigational Site Number 208002
Odense C, Denmark, 5000
Finland
Investigational Site Number 246001
Oulu, Finland, 90220
Investigational Site Number 246002
Turku, Finland, 20520
Germany
Investigational Site Number 276-016
Aschaffenburg, Germany, 63739
Investigational Site Number 276-010
Augsburg, Germany, 86150
Investigational Site Number 276-011
Berlin, Germany, 10707
Investigational Site Number 276-012
Erlangen, Germany, 91054
Investigational Site Number 276-009
Frankfurt am Main, Germany, 60389
Investigational Site Number 276-013
Frankfurt am Main, Germany, 60590
Investigational Site Number 276-004
Halle, Germany, 06120
Investigational Site Number 276-007
Krefeld, Germany, 47805
Investigational Site Number 276-003
Lebach, Germany, 66822
Investigational Site Number 276-019
Leipzig, Germany, 04103
Investigational Site Number 276-008
Ludwigsburg, Germany, 71640
Investigational Site Number 276-018
Magdeburg, Germany, 39104
Investigational Site Number 276-014
Magdeburg, Germany, 39130
Investigational Site Number 276-006
Moers, Germany, 47441
Investigational Site Number 276-001
München, Germany, 81377
Investigational Site Number 276-002
München, Germany, 81737
Investigational Site Number 276-015
Northeim, Germany, 37154
Investigational Site Number 276-017
Velbert, Germany, 42551
Investigational Site Number 276-005
Weiden/Oberpfalz, Germany, 92637
Investigational Site Number 276-020
Wolfsburg, Germany, 38440
Ireland
Investigational Site Number 372002
Dublin 24, Ireland
Investigational Site Number 372004
Galway, Ireland
Investigational Site Number 372001
Wilton, Ireland
Israel
Investigational Site Number 376002
Haifa, Israel, 31096
Investigational Site Number 376001
Jerusalem, Israel, 91120
Investigational Site Number 376005
Petach Tikva, Israel, 49100
Investigational Site Number 376003
Tel Aviv, Israel, 64239
Investigational Site Number 376004
Tel Hashomer, Israel, 52621
Italy
Investigational Site Number 380-005
Ancona, Italy, 60100
Investigational Site Number 380-029
Bergamo, Italy, 24128
Investigational Site Number 380-021
Bologna, Italy, 40133
Investigational Site Number 380-004
Brescia, Italy
Investigational Site Number 380-007
Candiolo, Italy
Investigational Site Number 380-012
Catania, Italy
Investigational Site Number 380-019
Catanzaro, Italy
Investigational Site Number 380-023
Firenze, Italy
Investigational Site Number 380-001
Genova, Italy, 16132
Investigational Site Number 380-014
Meldola, Italy
Investigational Site Number 380-016
Messina, Italy
Investigational Site Number 380-013
Milano, Italy
Investigational Site Number 380-015
Milano, Italy
Investigational Site Number 380-025
Milano, Italy
Investigational Site Number 380-022
Napoli, Italy
Investigational Site Number 380-028
Novara, Italy
Investigational Site Number 380-017
Padova, Italy
Investigational Site Number 380-002
Pisa, Italy
Investigational Site Number 380-008
Reggio Emilia, Italy, 42125
Investigational Site Number 380-024
Roma, Italy, 00189
Investigational Site Number 380-010
Roma, Italy
Investigational Site Number 380-011
Roma, Italy
Investigational Site Number 380-006
San Giovanni Rotondo, Italy
Investigational Site Number 380-026
Sassari, Italy
Investigational Site Number 380-020
Terni, Italy
Investigational Site Number 380-009
Torino, Italy
Investigational Site Number 380-003
Udine, Italy
Investigational Site Number 380-018
Verona, Italy
Lebanon
Investigational Site Number 1
Beirut, Lebanon
Mexico
Investigational Site Number 484002
Mexico DF, Mexico, 06760
Investigational Site Number 484009
Mexico DF, Mexico, 57205
Investigational Site Number 484001
Monterrey, Mexico, 64060
Investigational Site Number 484010
México, D.F., Mexico, 06726
Netherlands
Investigational Site Number 528001
Hoofddorp, Netherlands, 2134TM
Investigational Site Number 528002
Zwolle, Netherlands, 8025AB
Norway
Investigational Site Number 578002
Bergen, Norway, 5021
Investigational Site Number 578001
Oslo, Norway, 0407
Puerto Rico
Investigational Site Number 630-001
Rio Peidras, Puerto Rico, 927
Russian Federation
Investigational Site Number 643003
Kazan, Russian Federation, 420029
Investigational Site Number 643001
Moscow, Russian Federation, 115478
Investigational Site Number 643004
Moscow, Russian Federation, 115478
Investigational Site Number 643005
Moscow, Russian Federation, 115478
Investigational Site Number 643002
Moscow, Russian Federation, 123448
Investigational Site Number 643006
Moscow, Russian Federation, 129301
Investigational Site Number 643009
Saint-Petersburg, Russian Federation, 186646
Spain
Investigational Site Number 724016
Alicante, Spain, 03010
Investigational Site Number 724008
Barakaldo, Spain, 48903
Investigational Site Number 724012
Cáceres, Spain, 10003
Investigational Site Number 724002
Córdoba, Spain, 14004
Investigational Site Number 724013
Donostia, Spain, 20014
Investigational Site Number 724014
L'Hospitalet de Llobregat, Spain, 08907
Investigational Site Number 724003
Madrid, Spain, 28007
Investigational Site Number 724015
Madrid, Spain, 28034
Investigational Site Number 724005
Madrid, Spain, 28041
Investigational Site Number 724004
Málaga, Spain, 29010
Investigational Site Number 724010
Sabadell, Spain, 08208
Investigational Site Number 724011
Santander, Spain, 39008
Investigational Site Number 724006
Santiago de Compostela, Spain, 15706
Investigational Site Number 724001
Valencia, Spain, 46009
Investigational Site Number 724009
Valencia, Spain, 46009
Investigational Site Number 724007
Zaragoza, Spain, 50009
Sweden
Investigational Site Number 752_002
Jönköping, Sweden, 55185
Investigational Site Number 752_001
Växjö, Sweden, 35185
Thailand
Investigational Site Number 764005
Bangkok,TH, Thailand
Investigational Site Number 764002
Bangkok, Thailand, 10330
Investigational Site Number 764003
Bangkok, Thailand, 10400
Investigational Site Number 764008
Bangkok, Thailand, 10400
Investigational Site Number 764001
Bangkok, Thailand
Investigational Site Number 764006
Bangkok, Thailand
Investigational Site Number 764009
Chiang Mai, Thailand, 50200
Investigational Site Number 764004
Khon Kaen, Thailand, 40002
Investigational Site Number 764010
Laksi, Thailand, 10210
Investigational Site Number 764007
Lopburi, Thailand, 15000
Turkey
Investigational Site Number 792-06
Adana, Turkey, 01250
Investigational Site Number 792-01
Ankara, Turkey, 06100
Investigational Site Number 792-09
Ankara, Turkey, 06200
Investigational Site Number 792-08
Ankara, Turkey
Investigational Site Number 792-02
Capa, Turkey, 34390
Investigational Site Number 792010
Edirne, Turkey
Investigational Site Number 792-05
Gaziantep, Turkey
Investigational Site Number 792012
Istanbul, Turkey, 34093
Investigational Site Number 792-03
Istanbul, Turkey, 34865
Investigational Site Number 792-04
Istanbul, Turkey
Investigational Site Number 792-007
Izmir, Turkey, 35100
Investigational Site Number 792011
Izmir, Turkey
United Kingdom
Investigational Site Number 826005
Dudley, United Kingdom, DY1 2HQ
Investigational Site Number 826011
Hull, United Kingdom, HU165JQ
Investigational Site Number 826008
Leicester, United Kingdom, LE15WW
Investigational Site Number 826007
London, United Kingdom, NW1 2PJ
Investigational Site Number 826012
London, United Kingdom, SE17EH
Investigational Site Number 826003
Maidstone,, United Kingdom, ME169QQ
Investigational Site Number 826009
Manchester, United Kingdom, M204BX
Investigational Site Number 826004
Newcastle upon tyne, United Kingdom, NE77DN
Investigational Site Number 826006
Northwood, United Kingdom, HA62RN
Investigational Site Number 826002
Southampton, United Kingdom, SO60YD
Investigational Site Number 826001
Sutton, United Kingdom, SM25PT
Investigational Site Number 826010
Taunton, United Kingdom, TA15DA
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
  Study Documents (Full-Text)

Documents provided by Sanofi:
Study Protocol  [PDF] February 10, 2012
Statistical Analysis Plan  [PDF] June 1, 2016


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01571284    
Other Study ID Numbers: AFLIBC06097
2011-005724-17
U1111-1125-8949 ( Other Identifier: UTN )
First Posted: April 5, 2012    Key Record Dates
Results First Posted: February 27, 2018
Last Update Posted: April 18, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Irinotecan
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action