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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Sanofi

Current Primary Outcome: Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Clinical activity and pharmacodynamics [ Time Frame: 6 months ]

Original Secondary Outcome: Clinical activity and pharacodynamics [ Time Frame: 6 months ]

Information By: Sanofi

Dates:
Date Received: July 17, 2008
Date Started: July 2008
Date Completion:
Last Updated: February 17, 2016
Last Verified: February 2016