Ensayos clínicos

Inclusion Criteria

• Diagnosis of Primary Myelofibrosis (PMF) or Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis(post-ET/PV MF) as per revised World Health Organization (WHO) criteria
• High-risk or intermediate-2 risk Myelofibrosis (MF) as defined by the International Prognostic Scoring System (IPSS)
• Intermediate-I risk MF associated with symptomatic splenomegaly/hepatomegaly and/or unresponsive to available therapy
• Age at least 18 years 
• Life expectancy of ≥12 weeks
• Able to provide informed consent and willing to sign an informed consent form (ICF)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Evidence of acceptable organ function within seven days of initiating study drug

Exclusion Criteria

• Previous treatment with plitidepsin
• Any of the following therapies within two weeks prior to initiation of study drug
  • Chemotherapy (e.g., hydroxyurea)
  • Immunomodulatory drug therapy (e.g., thalidomide)
  • Immunosuppressive therapy
  • Corticosteroids >10 mg/day prednisone or equivalent
  • Erythropoietin
• Incomplete recovery from major surgery within four weeks of study entry
• Radiation therapy within four weeks of study entry
• Women of childbearing potential
• Women who are pregnant or are currently breastfeeding
• Myopathy grade > 2
• Known positive status for human immunodeficiency virus (HIV)
• Active hepatitis B or C virus (HBV or HCV) infection
• Diagnosis of another invasive malignancy
• Any acute active infection
• Known hypersensitivity to the study drug or any of its formulation components (e.g., Cremophor®)
• Treatment with any investigational product in the 30 days before inclusion in the study