Phase 2 Study to Evaluate Activity of 2 Dose Levels of Imetelstat in Participants with Intermediate-2 or High-Risk Myelofibrosis (MF) Previously Treated With a Janus Kinase (JAK) Inhibitor
This clinical trial is being conducted by Janssen Research & Development (Janssen) under the terms of an exclusive worldwide license and collaboration agreement with Geron. The first patient in the IMbark study was dosed in September 2015.
IMbark is a Phase 2, randomized, single-blind and multi-center study originally designed to evaluate two dosing regimens of imetelstat administered as a single agent to participants with intermediate-2 or high risk MF whose disease is relapsed after or refractory to JAK inhibitor treatment. The study consists of three stages: a screening phase, a treatment phase and a follow-up phase. Participants receive imetelstat at either 9.4 mg/kg (if enrolled in Arm 1) or 4.7 mg/kg (if enrolled in Arm 2) given intravenously every 3 weeks until disease progression, unacceptable toxicity, or study end. Imetelstat will be evaluated by spleen response and symptom response.
Enrollment of new participants was suspended in September 2016 following a planned internal data review, and remains suspended because the total number of patients enrolled to date is adequate to perform the protocol-specified primary analysis. Participants already enrolled in Arm 1 (9.4 mg/kg) may continue to receive imetelstat. Participants already enrolled in Arm 2 (4.7 mg/kg) may continue with their current imetelstat dose or have it increased to 9.4 mg/kg at the investigator's discretion. To learn more about this study, including enrollment criteria, locations and current status, visit ClinicalTrials.gov.
Imetelstat, a telomerase inhibitor, is an investigational treatment for cancer and has not been approved by the FDA or any other regulatory agency.
IMBark Study Design