CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
Simtuzumab +1 moredrug
Likely dose
Not stated in 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/NCT01369498
NCT01369498Phase 2Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Jun 9, 2011·Updated Jul 1, 2020

In Brief

A Phase 2 clinical trial evaluating Simtuzumab and Ruxolitinib for Myelofibrosis. Completed, enrolled 54 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelofibrosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 9, 2011
Enrollment StartJun 30, 2011
Primary CompletionJun 5, 2014
Study CompletionSep 24, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 15.1 years ago

Interventions

Simtuzumabdrug

Simtuzumab administered intravenously over approximately 30 minutes every 2 weeks

Ruxolitinibdrug

In Stage 2, participants will be on a stable dose of ruxolitinib