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Table 2 Completed and ongoing clinical trials of imetelstat in cancer patients

From: Roles of telomeres and telomerase in cancer, and advances in telomerase-targeted therapies

Identifier code/
Indication Objective Start/
completion date
Design Results Sponsor
NCT00594126/phase I Refractory or relapsed multiple myeloma Safety and MTD determination November 2007/July 2011 3 + 3 cohort; dose escalation study DLT: thrombocytopenia, neutropenia, anemia, aPTT prolongation, fatigue, nausea, anorexia and dizziness. Geron
NCT00732056/phase I Recurrent or metastatic breast cancer Safety, MTD, efficacy in combination with paclitaxel and bevacizumab July 2008/March 2012 3 + 3 cohort;dose escalation study DLT: thrombocytopenia, neutropenia. Geron
NCT00310895/phase I Solid tumor malignancies Safety and MTD determination March 2006/March 2013 3 + 3 cohort;
dose escalation study
DLT: thrombocytopenia, myelosuppression. Geron
NCT 00718601phase I Multiple myeloma Safety and MTD determination in combination with bortezomib and dexamethasone July 2008/October 2011 3 + 3 cohort; dose escalation study Results not available in public domain. Geron
NCT00124189/phase I Refractory chronic lymphoproliferative
Safety, tolerability, dose-limiting toxicities, and MTD July 2005/March 2013 Sequential dose cohort, open label, escalation trial evaluating one infusion duration of 2 h; weekly intravenous infusion Results not available in public domain. Geron
NCT00510445/phase I Metastatic non-small-cell lung cancer Safety, DLT, MTD in combination with a standard paclitaxel/carboplatin regimen July 2007/April 2011 Dose cohorts with a minimum of 3 patients Patients on imetelstat with short TL showed a trend towards longer median PFS as well as OS. However, imetelstat treatment in patients with long TL had no improvement in median PFS or OS.ADRs: neutropenia and thrombocytopenia. Geron
NCT01265927/phase I HER2+ breast cancer DLT in combination with trastuzumab January 2011/October 2015 Open label, non-randomized study Results not available in public domain. Geron
NCT01242930/phase II Multiple myeloma Improved outcome in patients previously treated with imetelstat. November 2010/December 2015 Imetelstat 2 h intravenous Infusion on day 1 and day 8 of a 28-day cycle Results not available in public domain. Geron
NCT02598661/phase III
Myelodysplastic syndrome Safety and efficacy November 2015/May 2019 Randomized, double blind Recruiting participants. Janssen
NCT02426086/phase II
IMbark study
patients previously treated with
JAK inhibitor
Safety and efficacy June 2015/March 2018 Randomized, single-blind, multicenter Recruiting participants. Janssen
NCT01243073/phase II Essential thrombocythemia Safety and efficacy December 2010/April 2015 Open label, single group Eighteen patients, all with positive hematologic response. Positive molecular response in most patients with JAK2 V617F mutation. ADRs: neutropenia, anemia. Geron
NCT01731951/phase II Myelofibrosis Efficacy October 2012/January 2019 Open label, parallel, active, not recruiting Complete or partial remission in 21 % patients. Bone marrow fibrosis was reversed in a few patients. Janssen
  1. ADR adverse drug reaction, aPTT activated partial thromboplastin time, DLT dose-limiting toxicity, MTD maximum tolerated dose, OS overall survival, PFS progression-free survival, TL telomere length