Status:
COMPLETED
Clinical Trial of Aplidin® in Patients With Primary Myelofibrosis
Lead Sponsor:
PharmaMar
Conditions:
Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
This trial tries to assess response rate (ORR) of plitidepsin in patients with: primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01149681
Start Date
July 1 2010
End Date
February 1 2011
Last Update
October 12 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
Azienda Ospedaliero Universitaria Careggi di Firenze
Florence, Italy, 50134