A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)

Trial Profile

A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)

Completed
Phase of Trial: Phase III

Latest Information Update: 11 May 2017

At a glance

  • Drugs Vosaroxin (Primary) ; Cytarabine
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms VALOR
  • Sponsors Sunesis Pharmaceuticals
  • Most Recent Events

    • 01 May 2017 According to a Sunesis Pharmaceuticals media release, the company has decided to withdraw the MAA for vosaroxin following interactions with CHMP of EMA as the company believed that a positive opinion by the committee was unlikely.
    • 22 Mar 2017 According to a Sunesis Pharmaceuticals media release, company announced that it has submitted its responses to the EMA Day 180 List of Outstanding Issues issued by the CHMP as part of the centralized review process of the MAA for vosaroxin as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older.
    • 06 Dec 2016 Results of updated survival information for patients ≥60 years (n=33) presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
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