A Randomized Phase II, Open-Label Study of the Efficacy and Safety of Orally Administered SAR302503 in Patients With Polycythemia Vera (PV) or Essential Thrombocythemia (ET) Who Are Resistant or Intolerant to Hydroxyurea.

Trial Profile

A Randomized Phase II, Open-Label Study of the Efficacy and Safety of Orally Administered SAR302503 in Patients With Polycythemia Vera (PV) or Essential Thrombocythemia (ET) Who Are Resistant or Intolerant to Hydroxyurea.

Discontinued
Phase of Trial: Phase II

Latest Information Update: 31 Jul 2014

At a glance

  • Drugs Fedratinib (Primary)
  • Indications Essential thrombocythaemia; Polycythaemia vera
  • Focus Therapeutic Use
  • Sponsors Sanofi
  • Most Recent Events

    • 18 Nov 2013 Status changed from recruiting to discontinued, according to a Sanofi media release. Development of fedratinib has been discontinued.
    • 09 Jan 2013 The number of treatment arms changed from 3 to 4. Now the treatment arm consist of an extra arm of 600 mg.
    • 04 Sep 2012 New source identified and integrated (M.D. Anderson Cancer Center, 2011-0851).
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