drugset / Trial / NCT01369498

Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis

NCT01369498

Phase 2 Completed 54 enrolled Gilead Sciences
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) on bone marrow fibrosis either alone or in combination with ruxolitinib in participants with primary myelofibrosis (PMF) and post polycythemia vera or post essential thrombocythemia myelofibrosis (ET/PV MF). The study is designed as a two-stage trial. In the stage 1, participants will be randomized into two cohorts to receive either 200 or 700 mg of study drug. In the stage 2, participants on ruxolitinib will be randomized to receive either 200 or 700 mg of study drug.

Timeline

Start
2011-06-30
Primary completion
2014-06-05
Completion
2014-09-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Simtuzumab Monoclonal antibody 200 mg Intravenous
Subject Simtuzumab Monoclonal antibody 700 mg Intravenous
Background Ruxolitinib Small molecule

Indications