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
Phase of Trial: Phase II
Latest Information Update: 16 Mar 2018
At a glance
- Drugs Imetelstat (Primary)
- Indications Myelofibrosis
- Focus Therapeutic Use
- Acronyms IMbarkTM
- Sponsors Geron Corporation; Janssen
- 16 Mar 2018 According to a Geron Corporation media release, the protocol of this trial is being amended to establish an extension phase of the trial to enable patients remaining in the treatment phase to continue to receive imetelstat treatment per investigator discretion. During the extension phase, standard data collection will primarily consist of safety information.
- 16 Mar 2018 According to a Geron Corporation media release, based on the rate of deaths occurring in the trial, the protocol-specified primary analysis, which includes an assessment of overall survival, will begin by the end of the second quarter of 2018. The trial will be completed after the protocol-specified primary analysis.
- 16 Mar 2018 According to a Geron Corporation media release, Janssen completed a third internal data review of IMbark in March 2018, based on a January 2018 data cut, to enable a protocol amendment to allow the long-term treatment and follow up of patients, including for survival, and the Collaborations Joint Steering Committee (JSC) made observations and implemented the actions related to safety and efficacy.