Trial intelligence / Profile preview

Anagrelide CR in MPN-related Thrombocytosis

NCT02125318Phase 2

Key facts

Status
Completed
Start
May 2014
Primary completion
May 2016
Countries
1
Modality
Small Molecules
Conditions
thrombocytosis
01

Overview

Phase 2, open-label, single-arm trial of anagrelide in thrombocytosis, sponsored by Galena Biopharma. Primary endpoint: Proportion of subjects who achieve a platelet response (CR or PR) at 24 weeks. Started May 2014; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Anagrelide CR

    Anagrelide Controlled Release (GALE-401)

03

Who it enrols

Adult patients with MPN-related thrombocytosis (platelets >= 600 x 10^9/L) who require platelet reduction therapy and are not refractory to anagrelide.

04

Endpoints

Primary

  • Proportion of subjects who achieve a platelet response (CR or PR)

Secondary

  • Number of subjects with adverse events

  • Plasma concentrations of anagrelide

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