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/ phase | 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 disease | Safety, tolerability, dose-limiting toxicities, and MTD | July 2005/March 2013 | Sequential dose cohort, open label, escalation trial evaluating one infusion duration of 2Â 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 2Â h intravenous Infusion on day 1 and day 8 of a 28-day cycle | Results not available in public domain. | Geron |
NCT02598661/phase III IMergeâ„¢ | Myelodysplastic syndrome | Safety and efficacy | November 2015/May 2019 | Randomized, double blind | Recruiting participants. | Janssen |
NCT02426086/phase II IMbark study | Myelofibrosis 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 21Â % patients. Bone marrow fibrosis was reversed in a few patients. | Janssen |