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Type(s) of Cancer
Myeloproliferative Neoplasms (MPNs)
Study Phase
Phase 3
Study Completion Date
June 2014
NCT01437787Uploaded 10-31-2014
Available for Download
PDS UID: Myelody_sanofi_2012_110
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
Provider Information
Provider Data DescriptionPrimary 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.
SponsorSanofi US Services Inc.
Data ProviderSanofi
Partial set or SubsetOriginal Data
Patients in dataset351
# of Patients Control158
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/2kxg-rt46
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryPrimary Objective: To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in patients with contraindications for MRI). Secondary Objectives: To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary. To evaluate the Overall Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo. To evaluate the Progression Free Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo. To evaluate the durability of splenic response. To evaluate the safety of IMP.
ConditionsHematopoietic Neoplasm
Intervention TypeDrug: SAR302503
Drug: Placebo
Drug(s)Drug: Placebo
Drug: SAR302503
Total Enrolled289
RandomizationRandomized
Blinding MethodDouble
Arms InterventionPlacebo comparator - Placebo Comparator
SAR302503 400 mg - Experimental
SAR302503 500 mg - Experimental
Secondary ID2011-001897-25
PubMed (PMID)26181658
Collaborator(s)N/A
Region(s)United States
Australia
Austria
Belgium
Brazil
Canada
France
Germany
Hungary
Ireland
Israel
Italy
Korea, Republic of
Lithuania
Mexico
Poland
Portugal
Romania
Russian Federation
Singapore
South Africa
Spain
Sweden
Taiwan
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLNot Provided
CRFefc12153-14-1-2-sample-crf.pdf
DATA DICTIONARYRead me first-info on data definition files SAR302503 EFC121153.docx
DATA (COMPARATOR ARM)SAS datasets.zip
DATA (COMPARATOR ARM)define.zip
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