drugset / Trial / NCT02426086

Study to Evaluate Activity of 2 Dose Levels of Imetelstat in Participants With Intermediate-2 or High-Risk Myelofibrosis (MF) Previously Treated With Janus Kinase (JAK) Inhibitor

NCT02426086

Phase 2 Completed 107 enrolled Geron Corporation
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of 2 dose regimens of imetelstat in participants with intermediate-2 or high-risk myelofibrosis (MF) whose disease is relapsed after or is refractory to Janus Kinase (JAK) inhibitor treatment. Key secondary endpoint includes overall survival.

Timeline

Start
2015-08-28
Primary completion
2018-04-26
Completion
2020-02-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Imetelstat Oligonucleotide (other) 4.7 mg/kg Intravenous
Subject Imetelstat Oligonucleotide (other) 9.4 mg/kg Intravenous

Indications