A Randomized, Single-Blind, Multicenter Phase 2 Study to Evaluate the Activity of 2 Dose Levels of Imetelstat in Subjects With Intermediate-2 or High-Risk Myelofibrosis (MF) Relapsed/Refractory to Janus Kinase (JAK) Inhibitor

Trial Profile

A Randomized, Single-Blind, Multicenter Phase 2 Study to Evaluate the Activity of 2 Dose Levels of Imetelstat in Subjects With Intermediate-2 or High-Risk Myelofibrosis (MF) Relapsed/Refractory to Janus Kinase (JAK) Inhibitor

Suspended
Phase of Trial: Phase II

Latest Information Update: 31 Jul 2017

At a glance

  • Drugs Imetelstat (Primary)
  • Indications Myelofibrosis
  • Focus Therapeutic Use
  • Acronyms IMbarkTM
  • Sponsors Geron Corporation; Janssen
  • Most Recent Events

    • 31 Jul 2017 According to a Geron Corporation media release, the company expects Janssen to perform an internal data review in the first quarter of 2018 to enable a potential protocol amendment to allow the long-term treatment and follow-up of patients, including for survival, beyond the current April 2018 per-protocol end-of-study date.
    • 10 Apr 2017 Enrollment of new patients to the trial will remain suspended as adequate patients are already enrolled to assess longer-term outcome measures, as reported in a Geron Corporation media release.
    • 10 Apr 2017 Janssen will evaluate maturing efficacy and safety data from the trial, including an assessment of overall survival, during 2018. Janssens decision to continue development of imetelstat in relapsed or refractory MF will depend upon the longer-term data from the trial, potential health authority feedback, and the totality of imetelstat program information, as reported in a Geron Corporation media release.
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