drugset / Trial / NCT01369498
Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Simtuzumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Simtuzumab | Monoclonal antibody | 700 mg | Intravenous |
| Background | Ruxolitinib | Small molecule | — | — |