13 completed, 5 terminated, 3 recruiting, 1 active not recruiting. 13 Phase 2, 10 Phase 1, 4 Phase 3, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 13 | Completed 7, Terminated 4, Active not recruiting 1, Recruiting 1 |
| Phase 1 | 10 | Completed 8, Terminated 2 |
| Phase 3 | 4 | Recruiting 3, Completed 1 |
| Not applicable | 1 | Terminated 1 |
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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 |
|---|---|---|---|---|---|---|
| Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function ITF2357 - Hepatic Impairment | Phase 1 | Completed | Italfarmaco | 24 | 2025-05-29 | 2026-06-18 |
| Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera Givinostat, Hydroxyurea - Polycythemia Vera | Phase 3 | Recruiting | Italfarmaco | 220 | 2024-03-26 | 2026-03-25 |
| Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy Givinostat, Placebo - Duchenne Muscular Dystrophy | Phase 3 | Recruiting | Italfarmaco | 138 | 2024-02-19 | 2026-07-24 |
| Perpetrator DDI Potential of Givinostat as Inhibitor and Inducer of CYP3A and P-gp Activity Givinostat 10 mg/mL, Midazolam 1mg/ml IV, Midazolam 2.5 mg oromucosal solution - Drug-Drug Interaction, Heathy Volunteer | Phase 1 | Completed | Italfarmaco | 26 | 2022-03-21 | 2025-01-06 |
| Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3) Givinostat - Drug Drug Interaction | Phase 1 | Completed | Italfarmaco | 8 | 2022-03-21 | 2025-01-24 |
| The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2) Givinostat, Clarithromycin - Drug Drug Interaction | Phase 1 | Completed | Italfarmaco | 20 | 2022-03-21 | 2024-08-16 |
| Placebo-Corrected Effects of Therapeutic Dose (100 mg) and Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC Interval ITF2357 10 mg/mL, Placebo, Moxifloxacin Hydrochloride - Duchenne and Becker Muscular Dystrophy, Polycytemia Vera | Phase 1 | Completed | Italfarmaco | 31 | 2021-04-13 | 2024-01-11 |
| Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy Givinostat, Placebo - Becker Muscular Dystrophy | Phase 2 | Completed | Italfarmaco | 51 | 2018-01-09 | 2024-11-18 |
| Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study Givinostat - Duchenne Muscular Dystrophy | Phase 2 / Phase 3 | Recruiting | Italfarmaco | 206 | 2017-10-24 | 2026-01-21 |
| Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy givinostat, placebo - Duchenne Muscular Dystrophy | Phase 3 | Completed | Italfarmaco | 179 | 2017-06-06 | 2023-02-02 |
| A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera Givinostat - Polycythemia Vera | Phase 1 / Phase 2 | Completed | Italfarmaco | 48 | 2013-10-01 | 2019-07-30 |
| A Study to Assess Safety/Tolerability, pk, Effects on Histology, Clinical Parameters of Givinostat in Children With DMD Givinostat - Duchenne Muscular Dystrophy (DMD) | Phase 1 / Phase 2 | Completed | Italfarmaco | 20 | 2013-04-01 | 2023-11-07 |
| Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms givinostat - Chronic Myeloproliferative Neoplasms | Phase 2 | Active not recruiting | Italfarmaco | 90 | 2013-03-01 | 2025-04-30 |
| Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis Givinostat - Juvenile Idiopathic Arthritis | Not applicable | Terminated | Italfarmaco | 1 | 2011-12-28 | 2021-04-06 |
| Efficacy and Safety Dose Finding Study of Givinostat to Treat Polyarticular Course Juvenile Idiopathic Arthritis Givinostat - Polyarticular Course Juvenile Idiopathic Arthritis | Phase 2 | Terminated | Italfarmaco | 16 | 2010-10-01 | 2014-04-16 |
| Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea, GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea - Polycythemia Vera | Phase 2 | Completed | Italfarmaco | 45 | 2009-06-01 | 2019-10-31 |
| Phase II Study of Histone-deacetylase Inhibitor ITF2357 in Refractory/Relapsed Lymphocytic Leukemia ITF2357 - Chronic Lymphocytic Leukemia | Phase 2 | Terminated | Italfarmaco | 3 | 2008-02-01 | 2022-01-27 |
| Trial of the Histone-Deacetylase Inhibitor ITF2357 Followed by Mechlorethamine in Relapsed/Refractory Hodgkin's Lymphoma ITF2357 - Hodgkin's Lymphoma | Phase 1 / Phase 2 | Completed | Italfarmaco | 24 | 2008-02-01 | 2021-05-11 |
| Phase IIA Study of the HDAC Inhibitor ITF2357 in Patients With JAK-2 V617F Positive Chronic Myeloproliferative Diseases ITF2357 - Myeloproliferative Diseases | Phase 2 | Completed | Italfarmaco | 29 | 2007-12-01 | 2019-12-03 |
| Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease ITF2357, Placebo - Crohn's Disease | Phase 1 / Phase 2 | Terminated | Italfarmaco | 51 | 2007-10-22 | 2023-07-19 |
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Muscular Dystrophy, Duchenne (6) · Polycythemia Vera (5) · Primary Myelofibrosis (3) · Thrombocythemia, Essential (3) · Arthritis, Juvenile (2) · Hodgkin Disease (2) · Myeloproliferative Disorders (2) · Crohn Disease (1) · Leukemia, Lymphocytic, Chronic, B-Cell (1) · Rare Diseases (1)
Italfarmaco (22)
Italy (15) · France (6) · Germany (6) · Netherlands (6) · Serbia (6) · United Kingdom (6) · Belgium (5) · Spain (5) · Canada (4) · Czechia (3) · Israel (3) · Poland (3) · Portugal (3) · United States (3) · Bulgaria (2)
Alessandro Rambaldi, MD (3) · Marlene Fonseca, MD (3) · Alessandro Massimo Gianni, MD (2) · Enrico Bertini, MD (1) · Eugenio Mercuri, MD, PhD (1) · Francesco Zulian, MD (1) · Giacomo Comi, MD (1) · Massimo Martelli, MD (1) · Nemanja Damjanov, MD, PhD (1) · Paolo Bettica, MD (1) · Paul Rutgeerts, MD (1) · Pavla Dolezalova, MD (1)
PMID 21308151, PMID 21538322, PMID 27566866, PMID 38508835, PMID 40830818
2016 (1), 2017 (1), 2023 (1)