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Myelofibrosis

"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients with Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Splenomegaly "

Unique Data Set IDMyelody_sanofi_2012_110
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients351Comparator (Control) Arm Enrolled Patients158RandomizationYesClinicalTrial.gov IDNCT01437787ClinicalTrial.gov URLhttp://clinicaltrials.gov/ct2/show/NCT01437787?term=EFC12153&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeOtherData Set TypeADS

Clinical Trial Title

"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients with Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Splenomegaly "

Trial Summary and Conditions

"Primary myelofibrosis (PMF) is a chronic myeloproliferative disorder characterized by a clonal proliferation involving pluripotent hematopoietic stem cells and clonal cell-derived cytokines. PMF usually affects patients with advanced age but reports on young people do exist. Current approved drug therapy for PMF such as erythropoiesis stimulating agents or hydroxyurea have not been shown to influence survival and are often used for palliative purposes only. SAR302503 (previously referred to as TG101348) is a protein kinase inhibitor, selective JAK2 inhibitor, which is being developed as an orally available treatment for MF."

Data Summary

These datasets are analysis datasets that bear some resemblance to CDISC ADaM standards. These datasets has been subsetted to include data for only the comparator arm of this clinical trial.

Study Objectives

Primary Endpoint: - Response Rate (RR), defined as the proportion of patients who have a greater than or equal to 35% reduction in volume of spleen size at the end of Cycle 6, and confirmed 4 weeks thereafter. Secondary Endpoints: - Symptom Response Rate (SRR), - OS (overall survival) of either 400 mg/day or 500 mg/day of IMP as compared to placebo. - PFS (progression free survival) of either 400 mg/day or 500 mg/day of IMP as compared to placebo. - Proportion of patients who have greater than or equal to 25% reduction in volume of spleen size at end of Cycle 6, and confirmed 4 weeks thereafter. - Duration of spleen response, measured by MRI (or CT scan in patients with contraindications for MRI). - Safety, as assessed by clinical, laboratory, ECG, and vital sign events; graded by the NCI CTCAE v4.03.

Outcome Measures

Outcomes documented in the protocol

Available Downloads:

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

PROTOCOL: efc12153-amended-protocol4.pdf

CRF: efc12153-14-1-2-sample-crf.pdf

DATA DICTIONARY: Read me first-info on data definition files SAR302503 EFC121153.docx

DATA (COMPARATOR ARM): SAS datasets.zip

DATA (COMPARATOR ARM): define.zip