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

Trial Profile

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

Discontinued
Phase of Trial: Phase III

Latest Information Update: 11 Aug 2017

At a glance

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

    • 09 Jan 2014 Planned End Date changed from Mar 2016 to Mar 2014, according to ClinicalTrials.gov.
    • 10 Dec 2013 Primary analysis presented at the 56th Annual Meeting and Exposition of the American Society of Hematology.
    • 10 Dec 2013 Symptom burden and health-related quality-of-life outcomes presented at the 56th Annual Meeting and Exposition of the American Society of Hematology.
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