A Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis

An Open-Label Study to Evaluate the Long-Term Effects of Orally Administered SAR302503 in Patients With Primary or Secondary Myelofibrosis

The purpose of this study is to evaluate the long-term effects of orally administered SAR302503 (TG101348) in patients with myelofibrosis who have completed the MF-TG101348-001 study.

SAR302503 (TG101348) is a potent small molecule inhibitor of Janus kinase 2 (JAK2). This is an extension study for a first-in-man, dose escalation study (MF-TG101348-001). The safety, tolerability and clinical activity of SAR302503 (TG101348) in subjects with myelofibrosis will be evaluated.

Inclusion Criteria:

• Completion of MF-TG101348-001 study
• Diagnosis of myelofibrosis
• At least 18 years of age

Exclusion Criteria:

• Any acute or chronic medical abnormality that may increase the risk associated with study participation