NCT01369498

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

A Phase 2 Study to Evaluate the Efficacy and Safety of GS-6624 in Adult Subjects With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
DRUG	Simtuzumab	Simtuzumab administered intravenously over approximately 30 minutes every 2 weeks
DRUG	Ruxolitinib	In Stage 2, participants will be on a stable dose of ruxolitinib

Timeline

• Start date: 2011-06-30
• Primary completion: 2014-06-05
• Completion: 2014-09-24
• First posted: 2011-06-09
• Last updated: 2020-07-01
• Results posted: 2020-07-01

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study