Clinical Trial of Aplidin® in Patients With Primary Myelofibrosis

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); or intermediate-I risk MF associated with symptomatic splenomegaly/hepatomegaly and/or unresponsive to available therapy.
• At least 18 years of age, with life expectancy of ≥12 weeks.
• Able to provide informed consent and being 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, or
• 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.