|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01149681 |
|
Date of registration:
|
22/06/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Clinical Trial of Aplidin® in Patients With Primary Myelofibrosis
|
|
Scientific title:
|
Open-label, Phase II Clinical Trial of Aplidin® (Plitidepsin) in Patients With Primary Myelofibrosis (PMF) and Post Polycythemia Vera/Essential Thrombocythemia (Post-PV/ET) Myelofibrosis |
|
Date of first enrolment:
|
July 2010 |
|
Target sample size:
|
12 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01149681 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Italy
|
United States
| | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Diagnosis of Primary Myelofibrosis (PMF) or Post Polycythemia Vera/Essential
Thrombocythemia Myelofibrosis(post-ET/PV MF) as per revised World Health Organization
(WHO) criteria.
2. 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.
3. At least 18 years of age, with life expectancy of =12 weeks.
4. Able to provide informed consent and being willing to sign an informed consent form
(ICF).
5. Eastern Cooperative Oncology Group (ECOG) performance status =2.
6. Evidence of acceptable organ function within seven days of initiating study drug
Exclusion Criteria:
1. Previous treatment with plitidepsin.
2. 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.
3. Incomplete recovery from major surgery within four weeks of study entry.
4. Radiation therapy within four weeks of study entry.
5. Women of childbearing potential
6. Women who are pregnant or are currently breastfeeding.
7. Myopathy grade > 2
8. Known positive status for human immunodeficiency virus (HIV).
9. Active hepatitis B or C virus (HBV or HCV) infection
10. Diagnosis of another invasive malignancy
11. Any acute active infection.
12. Known hypersensitivity to the study drug or any of its formulation components (e.g.,
Cremophor®).
13. Treatment with any investigational product in the 30 days before inclusion in the
study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Myelofibrosis
|
|
Intervention(s)
|
|
Drug: APLIDIN (plitidepsin)
|
|
Primary Outcome(s)
|
|
Objective response rate (ORR)
[Time Frame: up to 18 months (average)]
|
|
Secondary Outcome(s)
|
|
Quality of life (QoL)
[Time Frame: up to 18 months (average)]
|
|
Safety and Tolerability
[Time Frame: up to 18 months (average)]
|
|
Secondary ID(s)
|
|
APL-B-020-10
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|