Clinical Trial of Aplidin® in Patients With Primary Myelofibrosis
Completed · Phase 2
Conditions studied: Myelofibrosis
In brief
This is an open-label, Phase II Clinical Trial of Aplidin® (plitidepsin) in Patients with Primary Myelofibrosis and post polycythemia vera/essential thrombocythemia (Post-PV/ET) Myelofibrosis.
Key facts
- Study ID
- NCT01149681
- Run by
- PharmaMar
- People needed
- 12
- Starts
- 2010-07-01
- Expected to finish
- 2011-02-01
- Last updated by the study team
- 2020-10-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
- Azienda Ospedaliero Universitaria Careggi di Firenze — Florence, Italy
Full record on ClinicalTrials.gov
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