Clinical Trial: Clinical Trial of Aplidin® in Patients With Primary Myelofibrosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open-label, Phase II Clinical Trial of Aplidin® (Plitidepsin) in Patients With Primary Myelofibrosis (PMF) and Post Polycythemia Vera/Essential Thrombocythemia (Post-

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 Summary:

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 myelofibrosis (post-ET MF). Besides, the study results will allow to evaluate the effect of plitidepsin on bone marrow (BM) or peripheral blood histology and to determine the quality of life (QoL) and symptoms or participant patients.


Sponsor: PharmaMar

Current Primary Outcome: Objective response rate (ORR) [ Time Frame: up to 18 months (average) ]

Objective response rate (ORR) of plitidepsin in patients with:

  • primary myelofibrosis (PMF),
  • post-polycythemia vera myelofibrosis or
  • post-essential thrombocythemia myelofibrosis.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life (QoL) [ Time Frame: up to 18 months (average) ]
    Quality of life (QoL) and symptoms assessment according to the Myelofibrosis Symptom Assessment Form (MFSAF), after treatment with plitidepsin.
  • Safety and Tolerability [ Time Frame: up to 18 months (average) ]
    To evaluate the safety and tolerability of plitidepsin in this study population.


Original Secondary Outcome: Same as current

Information By: PharmaMar

Dates:
Date Received: June 22, 2010
Date Started: July 2010
Date Completion:
Last Updated: March 3, 2011
Last Verified: March 2011