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Colorectal

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.

Unique Data Set IDColorec_SanofiU_2007_131
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients1226Comparator (Control) Arm Enrolled Patients610RandomizationYesClinicalTrial.gov IDNCT00561470ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00561470?term=efc10262&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypePlacebo, Chemotherapy, DrugData Set TypeSDTM

Clinical Trial 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.

Trial Summary and Conditions

This is a prospective, multicenter, multinational, randomized (1:1), double-blind, parallel-arm study of aflibercept versus placebo in patients with MCRC being treated with FOLFIRI after failure of an oxaliplatin based regimen. Each patient will be treated until disease progression, unacceptable toxicity, or patient's refusal. Following documentation of progressive disease patients will be followed-up for survival status. Note that 614 subjects were randomized to a planned treatment arm of Placebo, however 4 of these subjects were given Aflibercept. These 4 patients were therefore excluded from all the de-identified datasets, bringing the total patient count to 610.

Data Summary

Datasets contain 610* de-identified subjects that were randomized to the placebo control arm (605 treated, 5 not treated). Data elements include: demographic, adverse events, cancer diagnosis, concomitant medications, control arm exposure, inclusion/exclusion criteria, laboratory data, medical history, PK, radio and surgical interventions, vital signs, ECG assessments, Tumor measurement and response data and study milestone events. *Note that a total of 614 subjects were randomized to a planned treatment arm of Placebo, however 4 of these subjects were given Aflibercept. These 4 patients were therefore excluded from all the de-identified datasets, bringing the total patient count down to 610.

Study Objectives

Primary objective: -To demonstrate improvement in overall survival (OS) with aflibercept by comparison to placebo in patients with colorectal cancer treated with FOLFIRI as second line treatment for metastatic disease. Secondary objectives: -To compare progression free survival (PFS) in the 2 treatment arms -To evaluate overall response rate (RR) in the 2 treatment arms -To evaluate the safety profile in the 2 treatment arms -To assess the pharmacokinetics of IV aflibercept -To assess immunogenicity of IV aflibercept

Outcome Measures

Primary endpoint: - Overall Survival, defined as the time interval from the date of randomization to the date of death due to any cause. Secondary endpoints: -Progression free survival (PFS) is defined as the time interval from the date of randomization to the date of first observation of disease progression or the date of death (due to any cause), whichever comes first. -Objective response (CR and PR) according to RECIST criteria. -Safety: TEAEs according to National Cancer Institute-Common Toxicity Criteria (NCI-CTC), version 3.0: type, frequency, severity, seriousness and relationship to study treatment. Laboratory abnormalities according to National Cancer Institute-Common Toxicity Criteria (NCI-CTC), version 3.0. Event driven anti-aflibercept antibodies (Ab) detection -Pharmacokinetics: Free aflibercept and aflibercept: VEGF complex at specified timepoints in all randomized and treated patients. -Anti-aflibercept Ab detection at prospectively specified time points in all patients.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: Sanofi_AVE0005_EFC10262_protocol.pdf

CRF: Sanofi_AVE0005_EFC10262_CRF.pdf

DATA DICTIONARY: Sanofi_AVE0005_EFC10262_data_discriptors.xlsx

DATA (COMPARATOR ARM): Sanofi_AVE0005_EFC10262_data_files_and_discriptors.zip