ASH News Daily 2012 - Monday, December 10, 2012 - (Page B-21)

T:10” NOW ENROLLING PATIENTS WITH CERTAIN FORMS OF MYELOFIBROSIS JAKARTA-2 JAK2 inhibition in a single-ARm TriAl of SAR302503 in myelofibrosis patients previously treated with ruxolitinib ClinicalTrials.gov Identifier: NCT01523171 To enroll a patient in JAKARTA-2 or to find out more about this trial, please visit www.jakartastudy.com or call 1-855-JAKARTA (for US only). JAKARTA-2 is a phase II, multicenter, open-label, single-arm study of SAR302503 in patients previously treated with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms, intermediate-2, or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis. Primary endpoint • Proportion of patients with ≥35% reduction in spleen volume at end of Cycle 6 Secondary endpoints • Proportion of patients with ≥50% reduction in total symptom score • Duration of spleen response • Proportion of patients with ≥50% reduction in length of spleen • Proportion of patients with ≥35% reduction in spleen volume at any time up to Cycle 6 • Effect on JAK2V617F allele burden • Safety • Plasma concentrations of SAR302503 T:14” Post-ruxolitinib patients with myelofibrosis (N=70) SAR302503 (oral) • Consecutive 28-day cycles • Starting dose: 400 mg qd Patients with myelofibrosis who are at least 18 years of age and meet the following criteria may be eligible for enrollment in JAKARTA-2: • Previous ruxolitinib treatment for at least 14 days, discontinued for ≥14 days before study entry • Myelofibrosis classified as intermediate-1 with symptoms, intermediate-2, or high-risk • Palpable splenomegaly ≥5 cm below costal margin • Platelet count ≥50 x 109/L JAK2=Janus kinase 2. SAR302503 is an investigational agent and has not been approved by the US Food and Drug Administration (FDA) or any other regulatory agency worldwide for the uses under investigation. US.ONP.12.10.001 10/12 Printed in U.S.A. ©2012 sanofi-aventis U.S. LLC, A SANOFI COMPANY 

Table of Contents for the Digital Edition of ASH News Daily 2012 - Monday, December 10, 2012

ASH News Daily 2012 - Monday, December 10, 2012

https://www.nxtbookmedia.com