CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
APLIDIN (plitidepsin)drug
Likely dose
APLIDIN (plitidepsin) 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01149681
NCT01149681Phase 2Completed
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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

PharmaMar·interventional·Posted Jun 23, 2010·Updated Oct 12, 2020

In Brief

A Phase 2 clinical trial evaluating APLIDIN (plitidepsin) for Myelofibrosis. Completed, enrolled 12 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelofibrosis
CountriesItaly, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 23, 2010
Enrollment StartJul 1, 2010
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.0 years ago

Interventions

APLIDIN (plitidepsin)drug

Aplidin® (plitidepsin) lyophilized powder and solvent for concentrate for solution for infusion. (2 mg plitidepsin vial and 4 ml ampoule). Plitidepsin will be administered at 5 mg/m2 intravenously diluted to a total volume of 250 ml in 0.9% saline or 5% dextrose solution on Day 1 and 15 every four weeks for a maximum period of 6 cycles.