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Clinical trials
catalyst calendar across sponsors →Studies where GERN is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
15 interventional · 1 expanded access · 3 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor TreatmentNCT04576156Overall survival (OS)Randomized · Open-label · Treatment | Phase 3 | Active, not recruiting | Drug: Imetelstat, Best Available Therapy (BAT) | Myelofibrosis | 327 | 2028-06-30 | in 681 d | 2026-07-08 |
| A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With MyelofibrosisNCT05371964Part 1: Incidence, Type, and Severity of Adverse Events, Including Dose-limiting Toxicity (DLT) During the DLT Observation Period and/or Study TreatmentOpen-label · Treatment | Phase 1 | Recruiting | Drug: Imetelstat sodium, Ruxolitinib | Myelofibrosis | 36 | Feb 2027 | ≤ 193 d | 2026-01-06 |
| Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)NCT02598661results2025-02-14Phase 2: Percentage of Participants Without Any Red Blood Cell (RBC) Transfusion During Any Consecutive 8-Weeks Period (All Participants)Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Active, not recruiting | Drug: Imetelstat Sodium, Placebo | Myelodysplastic Syndromes | 289 | 2023-10-13actual | — | 2026-07-17 |
| Imetelstat Sodium in Treating Participants With Primary or Secondary MyelofibrosisNCT01731951results2021-09-21MF Participants: Percentage of Participants With Overall Response (OR) - (Clinical Improvement[CI] or Partial Remission[PR] or Complete Remission[CR]) Per International Working Group - Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) CriteriaRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Imetelstat | Primary Myelofibrosis, Secondary Myelofibrosis, Myeloid Malignancies | 80 | 2018-05-24actual | — | 2021-09-21 |
| Study to Evaluate Activity of 2 Dose Levels of Imetelstat in Participants With Intermediate-2 or High-Risk Myelofibrosis (MF) Previously Treated With Janus Kinase (JAK) InhibitorNCT02426086results2021-09-14Percentage of Participants With Spleen ResponseRandomized · Single-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Imetelstat 4.7 mg/kg, Imetelstat 9.4 mg/kg | Myelofibrosis | 107 | 2018-04-26actual | — | 2021-09-14 |
| Open Label Study With Imetelstat to Determine Effect of Imetelstat in Patients w/ Previously Treated Multiple MyelomaNCT01242930Rate of Improvement in ResponseNon-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: Imetelstat (7.5 mg/kg), lenalidomide standard of care, Imetelstat (9.4 mg/kg) | Multiple Myeloma | 13 | Nov 2014actual | — | 2026-06-17 |
| Open Label Study to Evaluate the Activity of Imetelstat in Patients With Essential Thrombocythemia or Polycythemia VeraNCT01243073Hematologic ResponseOpen-label · Treatment | Phase 2 | Completed | Drug: Imetelstat | Essential Thrombocythemia, Polycythemia Vera | 20 | Oct 2013actual | — | 2016-01-26 |
| Imetelstat as Maintenance Therapy After Initial Induction Chemotherapy in Non-small Cell Lung Cancer (NSCLC)NCT01137968Progression-free survivalRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: imetelstat, Bevacizumab | Non-small Cell Lung Cancer | 116 | Sep 2013actual | — | 2016-01-26 |
| Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative Disease(CLD)NCT00124189Safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or recommended phase II dose of GRN163L in patients with relapsed or refractory chronic lymphoproliferative diseaseNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: GRN163L | Chronic Lymphoproliferative Diseases | 48 | Mar 2013actual | — | 2015-12-24 |
| Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor MalignanciesNCT00310895Safety, DLT, and MTDNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Imetelstat Sodium (GRN163L) | Solid Tumor Malignancies | 85 | Mar 2013actual | — | 2015-12-24 |
| Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast CancerNCT01256762Progression-free survivalRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: Imetelstat sodium, Bevacizumab, Paclitaxel | Locally Recurrent or Metastatic Breast Cancer | 166 | Oct 2012actual | — | 2016-01-26 |
| Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed MyelomaNCT00718601Maximum tolerated doseNon-randomized · Open-label | Phase 1 | Completed | Drug: Imetelstat Sodium (GRN163L) | Multiple Myeloma | 40 | Oct 2011actual | — | 2015-12-24 |
| A Study of GRN163L With Paclitaxel and Bevacizumab to Treat Patients With Locally Recurrent Or Metastatic Breast CancerNCT00732056Safety, MTD, efficacyOpen-label · Treatment | Phase 1 | Completed | Drug: GRN163L | Breast Cancer | 24 | Sep 2011actual | — | 2015-12-24 |
| Safety and Dose Study of GRN163L Administered to Treat Patients With Refractory or Relapsed Multiple MyelomaNCT00594126Safety and MTDNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Imetelstat Sodium (GRN163L) | Multiple Myeloma | 20 | Jul 2011actual | — | 2015-12-24 |
| Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung CancerNCT00510445Safety and MTDNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Imetelstat Sodium (GRN163L) | Lung Cancer | 27 | Apr 2011actual | — | 2015-12-24 |
| Expanded Access for Treatment With ImetelstatNCT05937568expanded access | — | Approved for marketing | Drug: Imetelstat | Myelodysplastic Syndromes | — | — | — | 2024-06-24 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19