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

NCT01571284 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: AFLIBC060972011-005724-17U1111-1125-8949
• Study Type: interventional
• Target: 781
• Locations: 23 countries
• Sites: 179

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

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (13)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  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.

  Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)

• Number of Participants With Abnormal Hematological Parameters

  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.

  Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)

• Number of Participants With International Normalized Ratio (INR)

  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.

  Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)

• Number of Participants With Abnormal Electrolytes Parameters

  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.

  Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)

• Number of Participants With Abnormal Renal and Liver Function Parameters

  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.

  Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)

• Creatinine Clearance of Aflibercept Plus FOLFIRI

  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).

  Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)

• Number of Participants With Other Abnormal Biochemistry Parameters

  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.

  Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)

• Number of Participants With Abnormal Non-Gradable Biochemistry Parameters

  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.

  Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)

• Number of Participants With Proteinuria Events

  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.

  Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)

• Number of Participants With Proteinuria Grade >=2

  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.

  Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)

• Number of Participants With Urinary Protein-Creatinine Ratio (UPCR)

  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.

  Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)

• Number of Participants With Proteinuria (Grade>=2) Concomitant With Hematuria and /or Hypertension

  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.

  Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)

• Number of Participants With Cycle Delay and/or Dose Modification

  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.

  Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)

Secondary Outcomes (5)

• 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

  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)

• Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales

  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)

• Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales

  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)

• Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score

  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)

• Change From Baseline in HRQL EQ-5D-3L VAS Score

  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)

Study Arms (1)

Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)

EXPERIMENTAL

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; Drug: FOLFIRI

Interventions

AFLIBERCEPT AVE0005 DRUG

Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous

Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)

FOLFIRI DRUG

irinotecan, 5-FU and leucovorin

Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (179)

Investigational Site Number 840-002

Muscle Shoals, Alabama, 35661, United States

Location

Investigational Site Number 840-008

Corona, California, 92879, United States

Location

Investigational Site Number 840-007

Fountain Valley, California, 92708, United States

Location

Investigational Site Number 840-004

Riverside, California, 92501, United States

Location

Investigational Site Number 840-006

Indianapolis, Indiana, 46254, United States

Location

Investigational Site Number 840-011

Metairie, Louisiana, 70006, United States

Location

Investigational Site Number 840-001

Rockville, Maryland, 20850, United States

Location

Investigational Site Number 840-010

Howell Township, New Jersey, 07731, United States

Location

Investigational Site Number 840-012

Albuquerque, New Mexico, 87106, United States

Location

Investigational Site Number 840-009

Farmington, New Mexico, 87401, United States

Location

Investigational Site Number 840-003

Lake Success, New York, 11042, United States

Location

Investigational Site Number 840-005

Middletown, Ohio, 45042, United States

Location

Investigational Site Number 056010

Aalst, 9300, Belgium

Location

Investigational Site Number 056015

Arlon, 6700, Belgium

Location

Investigational Site Number 056004

Bonheiden, 2820, Belgium

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Investigational Site Number 056001

Edegem, 2650, Belgium

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Investigational Site Number 056012

Ghent, 9000, Belgium

Location

Investigational Site Number 056009

Haine-Saint-Paul, 7100, Belgium

Location

Investigational Site Number 056003

Liège, 4000, Belgium

Location

Investigational Site Number 056007

Liège, 4000, Belgium

Location

Investigational Site Number 056014

Loverval, 6280, Belgium

Location

Investigational Site Number 056013

Turnhout, 2300, Belgium

Location

Investigational Site Number 056002

Verviers, 4800, Belgium

Location

Investigational Site Number 056011

Yvoir, 5530, Belgium

Location

Investigational Site Number 008

Brasília, 70390-150, Brazil

Location

Investigational Site Number 009

Curitiba, 80530-010, Brazil

Location

Investigational Site Number 012

Fortaleza, Brazil

Location

Investigational Site Number 006

Passo Fundo, 99010-260, Brazil

Location

Investigational Site Number 003

Porto Alegre, 90470-340, Brazil

Location

Investigational Site Number 002

Rio de Janeiro, 22793-080, Brazil

Location

Investigational Site Number 011

Salvador, 40170-070, Brazil

Location

Investigational Site Number 013

São José do Rio Preto, 15090-000, Brazil

Location

Investigational Site Number 001

São Paulo, 01246-000, Brazil

Location

Investigational Site Number 004

São Paulo, 01308-050, Brazil

Location

Investigational Site Number 005

São Paulo, 01321-000, Brazil

Location

Investigational Site Number 124002

Calgary, T2N 4N2, Canada

Location

Investigational Site Number 124003

Montreal, H1T 2M4, Canada

Location

Investigational Site Number 124005

Montreal, H2W1S6, Canada

Location

Investigational Site Number 124004

Ottawa, K1H8L6, Canada

Location

Investigational Site Number 124006

Québec, G1S4L8, Canada

Location

Investigational Site Number 124001

Toronto, M4N3M5, Canada

Location

Investigational Site Number 152001

Santiago, Chile

Location

Investigational Site Number 152003

Santiago, Chile

Location

Investigational Site Number 203005

Brno, 65653, Czechia

Location

Investigational Site Number 203003

Olomouc, 77900, Czechia

Location

Investigational Site Number 203001

Ostrava, 70852, Czechia

Location

Investigational Site Number 203002

Prague, 12808, Czechia

Location

Investigational Site Number 203004

Prague, 15006, Czechia

Location

Investigational Site Number 203006

Zlín, Czechia

Location

Investigational Site Number 208001

Cph Ø, 2100, Denmark

Location

Investigational Site Number 208003

Hillerød, 3400, Denmark

Location

Investigational Site Number 208002

Odense C, 5000, Denmark

Location

Investigational Site Number 246001

Oulu, 90220, Finland

Location

Investigational Site Number 246002

Turku, 20520, Finland

Location

Investigational Site Number 276-016

Aschaffenburg, 63739, Germany

Location

Investigational Site Number 276-010

Augsburg, 86150, Germany

Location

Investigational Site Number 276-011

Berlin, 10707, Germany

Location

Investigational Site Number 276-012

Erlangen, 91054, Germany

Location

Investigational Site Number 276-009

Frankfurt am Main, 60389, Germany

Location

Investigational Site Number 276-013

Frankfurt am Main, 60590, Germany

Location

Investigational Site Number 276-004

Halle, 06120, Germany

Location

Investigational Site Number 276-007

Krefeld, 47805, Germany

Location

Investigational Site Number 276-003

Lebach, 66822, Germany

Location

Investigational Site Number 276-019

Leipzig, 04103, Germany

Location

Investigational Site Number 276-008

Ludwigsburg, 71640, Germany

Location

Investigational Site Number 276-018

Magdeburg, 39104, Germany

Location

Investigational Site Number 276-014

Magdeburg, 39130, Germany

Location

Investigational Site Number 276-006

Moers, 47441, Germany

Location

Investigational Site Number 276-001

München, 81377, Germany

Location

Investigational Site Number 276-002

München, 81737, Germany

Location

Investigational Site Number 276-015

Northeim, 37154, Germany

Location

Investigational Site Number 276-017

Velbert, 42551, Germany

Location

Investigational Site Number 276-005

Weiden/Oberpfalz, 92637, Germany

Location

Investigational Site Number 276-020

Wolfsburg, 38440, Germany

Location

Investigational Site Number 372002

Dublin, Ireland

Location

Investigational Site Number 372004

Galway, Ireland

Location

Investigational Site Number 372001

Wilton, Ireland

Location

Investigational Site Number 376002

Haifa, 31096, Israel

Location

Investigational Site Number 376001

Jerusalem, 91120, Israel

Location

Investigational Site Number 376005

Petah Tikva, 49100, Israel

Location

Investigational Site Number 376003

Tel Aviv, 64239, Israel

Location

Investigational Site Number 376004

Tel Litwinsky, 52621, Israel

Location

Investigational Site Number 380-005

Ancona, 60100, Italy

Location

Investigational Site Number 380-029

Bergamo, 24128, Italy

Location

Investigational Site Number 380-021

Bologna, 40133, Italy

Location

Investigational Site Number 380-004

Brescia, Italy

Location

Investigational Site Number 380-007

Candiolo, Italy

Location

Investigational Site Number 380-012

Catania, Italy

Location

Investigational Site Number 380-019

Catanzaro, Italy

Location

Investigational Site Number 380-023

Florence, Italy

Location

Investigational Site Number 380-001

Genova, 16132, Italy

Location

Investigational Site Number 380-014

Meldola, Italy

Location

Investigational Site Number 380-016

Messina, Italy

Location

Investigational Site Number 380-013

Milan, Italy

Location

Investigational Site Number 380-015

Milan, Italy

Location

Investigational Site Number 380-025

Milan, Italy

Location

Investigational Site Number 380-022

Napoli, Italy

Location

Investigational Site Number 380-028

Novara, Italy

Location

Investigational Site Number 380-017

Padua, Italy

Location

Investigational Site Number 380-002

Pisa, Italy

Location

Investigational Site Number 380-008

Reggio Emilia, 42125, Italy

Location

Investigational Site Number 380-024

Roma, 00189, Italy

Location

Investigational Site Number 380-010

Roma, Italy

Location

Investigational Site Number 380-011

Roma, Italy

Location

Investigational Site Number 380-006

San Giovanni Rotondo, Italy

Location

Investigational Site Number 380-026

Sassari, Italy

Location

Investigational Site Number 380-020

Terni, Italy

Location

Investigational Site Number 380-009

Torino, Italy

Location

Investigational Site Number 380-003

Udine, Italy

Location

Investigational Site Number 380-018

Verona, Italy

Location

Investigational Site Number 1

Beirut, Lebanon

Location

Investigational Site Number 484002

Mexico City, 06760, Mexico

Location

Investigational Site Number 484009

Mexico City, 57205, Mexico

Location

Investigational Site Number 484010

México, D.F., 06726, Mexico

Location

Investigational Site Number 484001

Monterrey, 64060, Mexico

Location

Investigational Site Number 528001

Hoofddorp, 2134TM, Netherlands

Location

Investigational Site Number 528002

Zwolle, 8025AB, Netherlands

Location

Investigational Site Number 578002

Bergen, 5021, Norway

Location

Investigational Site Number 578001

Oslo, 0407, Norway

Location

Investigational Site Number 630-001

Rio Peidras, 927, Puerto Rico

Location

Investigational Site Number 643003

Kazan', 420029, Russia

Location

Investigational Site Number 643001

Moscow, 115478, Russia

Location

Investigational Site Number 643004

Moscow, 115478, Russia

Location

Investigational Site Number 643005

Moscow, 115478, Russia

Location

Investigational Site Number 643002

Moscow, 123448, Russia

Location

Investigational Site Number 643006

Moscow, 129301, Russia

Location

Investigational Site Number 643009

Saint Petersburg, 186646, Russia

Location

Investigational Site Number 724016

Alicante, 03010, Spain

Location

Investigational Site Number 724008

Barakaldo, 48903, Spain

Location

Investigational Site Number 724012

Cáceres, 10003, Spain

Location

Investigational Site Number 724002

Córdoba, 14004, Spain

Location

Investigational Site Number 724013

Donostia / San Sebastian, 20014, Spain

Location

Investigational Site Number 724014

L'Hospitalet de Llobregat, 08907, Spain

Location

Investigational Site Number 724003

Madrid, 28007, Spain

Location

Investigational Site Number 724015

Madrid, 28034, Spain

Location

Investigational Site Number 724005

Madrid, 28041, Spain

Location

Investigational Site Number 724004

Málaga, 29010, Spain

Location

Investigational Site Number 724010

Sabadell, 08208, Spain

Location

Investigational Site Number 724011

Santander, 39008, Spain

Location

Investigational Site Number 724006

Santiago de Compostela, 15706, Spain

Location

Investigational Site Number 724001

Valencia, 46009, Spain

Location

Investigational Site Number 724009

Valencia, 46009, Spain

Location

Investigational Site Number 724007

Zaragoza, 50009, Spain

Location

Investigational Site Number 752_002

Jönköping, 55185, Sweden

Location

Investigational Site Number 752_001

Vaxjo, 35185, Sweden

Location

Investigational Site Number 764002

Bangkok, 10330, Thailand

Location

Investigational Site Number 764003

Bangkok, 10400, Thailand

Location

Investigational Site Number 764008

Bangkok, 10400, Thailand

Location

Investigational Site Number 764001

Bangkok, Thailand

Location

Investigational Site Number 764006

Bangkok, Thailand

Location

Investigational Site Number 764005

Bangkok,TH, Thailand

Location

Investigational Site Number 764009

Chiang Mai, 50200, Thailand

Location

Investigational Site Number 764004

Khon Kaen, 40002, Thailand

Location

Investigational Site Number 764010

Laksi, 10210, Thailand

Location

Investigational Site Number 764007

Lopburi, 15000, Thailand

Location

Investigational Site Number 792-06

Adana, 01250, Turkey (Türkiye)

Location

Investigational Site Number 792-01

Ankara, 06100, Turkey (Türkiye)

Location

Investigational Site Number 792-09

Ankara, 06200, Turkey (Türkiye)

Location

Investigational Site Number 792-08

Ankara, Turkey (Türkiye)

Location

Investigational Site Number 792-02

Çapa, 34390, Turkey (Türkiye)

Location

Investigational Site Number 792010

Edirne, Turkey (Türkiye)

Location

Investigational Site Number 792-05

Gaziantep, Turkey (Türkiye)

Location

Investigational Site Number 792012

Istanbul, 34093, Turkey (Türkiye)

Location

Investigational Site Number 792-03

Istanbul, 34865, Turkey (Türkiye)

Location

Investigational Site Number 792-04

Istanbul, Turkey (Türkiye)

Location

Investigational Site Number 792-007

Izmir, 35100, Turkey (Türkiye)

Location

Investigational Site Number 792011

Izmir, Turkey (Türkiye)

Location

Investigational Site Number 826005

Dudley, DY1 2HQ, United Kingdom

Location

Investigational Site Number 826011

Hull, HU165JQ, United Kingdom

Location

Investigational Site Number 826008

Leicester, LE15WW, United Kingdom

Location

Investigational Site Number 826007

London, NW1 2PJ, United Kingdom

Location

Investigational Site Number 826012

London, SE17EH, United Kingdom

Location

Investigational Site Number 826003

Maidstone, ME169QQ, United Kingdom

Location

Investigational Site Number 826009

Manchester, M204BX, United Kingdom

Location

Investigational Site Number 826004

Newcastle upon Tyne, NE77DN, United Kingdom

Location

Investigational Site Number 826006

Northwood, HA62RN, United Kingdom

Location

Investigational Site Number 826002

Southampton, SO60YD, United Kingdom

Location

Investigational Site Number 826001

Sutton, SM25PT, United Kingdom

Location

Investigational Site Number 826010

Taunton, TA15DA, United Kingdom

Location

Related Publications (1)

• Riechelmann RP, Srimuninnimit V, Bordonaro R, Kavan P, Di Bartolomeo M, Maiello E, Cicin I, Garcia-Alfonso P, Chau I, Fedyanin MY, Martos CF, Ter-Ovanesov M, Peeters M, Ko YJ, Yalcin S, Karthaus M, Aparicio J, Heinemann V, Picard P, Bury D, Drea E, Sobrero A. Aflibercept Plus FOLFIRI for Second-line Treatment of Metastatic Colorectal Cancer: Observations from the Global Aflibercept Safety and Health-Related Quality-of-Life Program (ASQoP). Clin Colorectal Cancer. 2019 Sep;18(3):183-191.e3. doi: 10.1016/j.clcc.2019.05.003. Epub 2019 May 15.

  PMID: 31221542 DERIVED

MeSH Terms

Interventions

aflibercept; IFL protocol

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 5, 2012
• Study Start: May 30, 2012
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: April 17, 2018
• Results First Posted: February 27, 2018

Record last verified: 2018-03

Locations

BR (11); DE (20); ME (4); SE (2); CA (6); US (12); GB (12); FI (2); IT (28); ES (16); PR (1); IL (5); TH (10); NL (2); RU (7); TU (12); LE (1); CL (2); IE (3); CZ (6); DK (3); BE (12); NO (2)