14 completed, 3 active not recruiting, 2 recruiting, 1 approved for marketing. 11 Phase 1, 9 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 7, Recruiting 2, Active not recruiting 1, Withdrawn 1 |
| Phase 2 | 9 | Completed 7, Active not recruiting 1, Not yet recruiting 1 |
| Phase 3 | 2 | Active not recruiting 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Phase 2 Study Of Imetelstat for Patient With Myelodysplastic/Myeloproliferative Neoplasms Imetelstat - Phase II, Imetelstat | Phase 2 | Not yet recruiting | M.D. Anderson Cancer Center | 30 | 2026-10-08 | 2026-04-24 |
| Imetelstat Combinations in Relapsed AML Imetelstat, Azacitidine, Venetoclax - Relapsed Acute Myeloid Leukemia | Phase 1 | Recruiting | Douglas Tremblay | 36 | 2026-01-02 | 2026-04-22 |
| A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy - Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Myelodysplastic Syndrome | Phase 1 | Recruiting | Children's Oncology Group | 36 | 2025-02-04 | 2026-08-25 |
| Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy Imetelstat sodium - Myelodysplastic Syndromes, Acute Myeloid Leukemia | Phase 2 | Completed | GCP-Service International West GmbH | 46 | 2023-06-05 | 2026-10-02 |
| A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis Imetelstat sodium, Ruxolitinib - Myelofibrosis | Phase 1 | Active not recruiting | Geron Corporation | 30 | 2022-05-04 | 2026-08-26 |
| 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 Treatment Imetelstat, Best Available Therapy (BAT) - Myelofibrosis | Phase 3 | Active not recruiting | Geron Corporation | 327 | 2021-04-12 | 2026-07-08 |
| Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) Imetelstat Sodium, Placebo - Myelodysplastic Syndromes | Phase 2 / Phase 3 | Active not recruiting | Geron Corporation | 289 | 2016-01-12 | 2026-07-17 |
| 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) Inhibitor Imetelstat 4.7 mg/kg, Imetelstat 9.4 mg/kg - Myelofibrosis | Phase 2 | Completed | Geron Corporation | 107 | 2015-08-28 | 2021-09-14 |
| Imetelstat Given Intravenously Alone and With Standard 13-Cis-Retinoic Acid in Children With Neuroblastoma Imetelstat - Neuroblastoma | Phase 1 | Withdrawn | NCIC Clinical Trials Group | 2013-07-30 | 2020-09-21 | |
| Imetelstat Sodium in Treating Participants With Primary or Secondary Myelofibrosis Imetelstat - Primary Myelofibrosis, Secondary Myelofibrosis | Phase 2 | Completed | Geron Corporation | 80 | 2012-10-29 | 2021-09-21 |
| A Study Inhibiting Telomerase to Reverse Trastuzumab Resistance in HER2+ Breast Cancer GRN163L in combination with trastuzumab - Breast Neoplasms | Phase 1 | Completed | Indiana University | 10 | 2011-01-01 | 2015-10-27 |
| Open Label Study to Evaluate the Activity of Imetelstat in Patients With Essential Thrombocythemia or Polycythemia Vera Imetelstat - Essential Thrombocythemia, Polycythemia Vera | Phase 2 | Completed | Geron Corporation | 20 | 2010-12-01 | 2016-01-26 |
| Open Label Study With Imetelstat to Determine Effect of Imetelstat in Patients w/ Previously Treated Multiple Myeloma Imetelstat (7.5 mg/kg), lenalidomide standard of care, Imetelstat (9.4 mg/kg) - Multiple Myeloma | Phase 2 | Completed | Geron Corporation | 13 | 2010-11-01 | 2026-06-17 |
| Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer Imetelstat sodium, Bevacizumab, Paclitaxel - Locally Recurrent or Metastatic Breast Cancer | Phase 2 | Completed | Geron Corporation | 166 | 2010-11-01 | 2016-01-26 |
| Imetelstat as Maintenance Therapy After Initial Induction Chemotherapy in Non-small Cell Lung Cancer (NSCLC) imetelstat, Bevacizumab - Non-small Cell Lung Cancer | Phase 2 | Completed | Geron Corporation | 116 | 2010-05-01 | 2016-01-26 |
| A Study of GRN163L With Paclitaxel and Bevacizumab to Treat Patients With Locally Recurrent Or Metastatic Breast Cancer GRN163L - Breast Cancer | Phase 1 | Completed | Geron Corporation | 24 | 2008-07-01 | 2015-12-24 |
| Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed Myeloma Imetelstat Sodium (GRN163L) - Multiple Myeloma | Phase 1 | Completed | Geron Corporation | 40 | 2008-07-01 | 2015-12-24 |
| Safety and Dose Study of GRN163L Administered to Treat Patients With Refractory or Relapsed Multiple Myeloma Imetelstat Sodium (GRN163L) - Multiple Myeloma | Phase 1 | Completed | Geron Corporation | 20 | 2007-11-01 | 2015-12-24 |
| Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer Imetelstat Sodium (GRN163L) - Lung Cancer | Phase 1 | Completed | Geron Corporation | 27 | 2007-07-01 | 2015-12-24 |
| Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies Imetelstat Sodium (GRN163L) - Solid Tumor Malignancies | Phase 1 | Completed | Geron Corporation | 85 | 2006-03-01 | 2015-12-24 |
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Recurrence (5) · Myelodysplastic Syndromes (4) · Primary Myelofibrosis (4) · Breast Neoplasms (3) · Multiple Myeloma (3) · Neoplasms, Plasma Cell (3) · Carcinoma, Non-Small-Cell Lung (2) · Leukemia, Myeloid, Acute (2) · Myeloproliferative Disorders (2) · Disease (1) · Leukemia, Lymphocytic, Chronic, B-Cell (1) · Leukemia, Myelomonocytic, Juvenile (1) · Leukemia, Prolymphocytic, T-Cell (1) · Lung Neoplasms (1) · Neuroblastoma (1)
imetelstat (20) · GRN163L peptide (12) · Bevacizumab (2) · Azacitidine (1) · Biopsy (1) · Cytarabine (1) · Hydrocortisone (1) · Lenalidomide (1) · Leucovorin (1) · Methotrexate (1) · Paclitaxel (1) · Specimen Handling (1) · Spinal Puncture (1) · Trastuzumab (1) · fludarabine (1)
United States (19) · Germany (6) · Canada (5) · France (4) · Belgium (3) · Israel (3) · Italy (3) · South Korea (3) · Spain (3) · United Kingdom (3) · Australia (2) · Poland (2) · Russia (2) · Switzerland (2) · Taiwan (2)
Kathy Miller, MD (3) · Joe Eid (2) · Stephen Kelsey, MD (2) · Alexandra M Stevens (1) · Bravo G Montalban, MD (1) · Carol Ann Huff, M.D. (1) · Douglas Tremblay, MD (1) · Joan Schiller, MD (1) · John Mascarenhas, MD (1) · Michelle Mudge-Riley, DO (1) · Steve Kelsey, MD (1) · Ted Shih, PharmD (1) · Tymara Berry, MD (1) · Uwe Platzbecker, MD (1)
PMID 26332545, PMID 26332546, PMID 32732354, PMID 33108243, PMID 34138638, PMID 35510486, PMID 38048786, PMID 41135032, PMID 41568521
2015 (2), 2023 (1), UM1CA228823 (1)