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A Multinational, Randomized, Double-Blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks versus Placebo in Patients Treated with Gemcitabine for Metastatic Pancreatic Cancer

Unique Dataset IDNCT00574275
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients546Comparator (Control) Arm Enrolled Patients273RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypePlacebo, Drug, ChemotherapyDataset TypeSDTM

Clinical Trial Title

A Multinational, Randomized, Double-Blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks versus Placebo in Patients Treated with Gemcitabine for Metastatic Pancreatic Cancer

Trial Summary and Conditions

This is a prospective, multicenter, multinational, randomized (1:1), double-blind, placebo-controlled, parallel-group study comparing the efficacy of aflibercept in term of overall survival versus placebo administered on top of gemcitabine in patients with metastatic pancreatic cancer (MPC). 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.

Data Summary

SDTM datasets contain 273* de-identified subjects that were randomized to the placebo control arm (269 treated, 4 not treated). Data elements include: demographic, adverse events, cancer diagnosis, concomitant medications, control arm exposure, inclusion/exclusion criteria, laboratory data, medical history, radio and surgical interventions, vital signs, quality of life questionnaires, ECG assessments, Tumor measurement and response data and study milestone events. *Note that a total of 275 subjects were randomized to a planned treatment arm of Placebo, however 2 of these subjects were given Aflibercept. These 2 patients were therefore excluded from all the de-identified datasets, bringing the total patient count down to 273

Study Objectives

Primary: To demonstrate improvement in overall survival (OS) with aflibercept by comparison to placebo in patients treated with gemcitabine for metastatic pancreatic cancer (MPC). Secondary: To compare in the 2 treatment groups (by sequential order of statistical analysis): - Progression-free survival (PFS) - Clinical benefit based on the measurement of tumor-related symptoms including a composite score of pain severity assessed by visual analog scale (VAS), analgesic consumption as morphine equivalents, Eastern Cooperative Oncology Group performance status (ECOG PS) and weight change from baseline. Clinical benefit was assessed by time to symptom worsening (TTSW) evaluated from the time of randomization to symptom worsening, as well as improvement in tumor related symptoms. - Overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. - To assess the overall safety in the 2 treatment groups - To assess immunogenicity of intravenous (IV) aflibercept - To perform population pharmacokinetic (PK) evaluation

Outcome Measures

Efficacy: The primary efficacy endpoint was OS, defined as the time interval from the date of randomization to the date of death due to any cause; if death was not observed during the study, data on OS was censored at the last date the patient was known to be alive, or the study cutoff date, whichever was earlier. Secondary efficacy endpoints included PFS, clinical benefit assessed by TTSW, and objective responses (complete response [CR] and partial response [PR]). Safety: Safety and tolerability were assessed through the collection of the following information: physical examinations including body weight and vital signs (blood pressure), laboratory data (including complete blood count, biochemistry, and urinalysis), other tests as clinically indicated, adverse events (AEs), serious AEs (SAEs), concomitant medications, and cause of treatment withdrawal. The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used in this study to grade AEs. Pharmacokinetics: An exploratory analysis of endogenous vascular endothelial growth factor (VEGF) levels was conducted at baseline in all patients who were randomized at study sites equipped with a 4 degree C centrifuge. Free aflibercept and bound aflibercept (aflibercept:VEGF complexes) and antiaflibercept antibodies were analyzed.

Available Downloads:

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

PROTOCOL: sanofi_AVE0005_efc10547_protocol_redacted.pdf

CRF: sanofi_AVE0005_efc10547_sample_crf_redacted.pdf

DATA DICTIONARY: sanofi_ave0005_efc10547_data_definition.xls

DATA (COMPARATOR ARM): sanofi_AVE0005_EFC10547_datasets_and