10 completed, 2 terminated. 6 Phase 2, 4 Phase 1, 1 Early Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 5, Terminated 1 |
| Phase 1 | 4 | Completed 4 |
| Early Phase 1 | 1 | Completed 1 |
| Phase 3 | 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 |
|---|---|---|---|---|---|---|
| Pracinostat and Gemtuzumab Ozogamicin (PraGO) in Patients With Relapsed/Refractory Acute Myeloid Leukemia Gemtuzumab Ozogamicin 3 mg/m^2, Gemtuzumab Ozogamicin 2 mg/m^2, Pracinostat - 45 mg - Relapsed Adult AML | Phase 1 | Completed | Medical College of Wisconsin | 14 | 2019-05-24 | 2022-06-30 |
| A Study In Healthy Male Volunteers Designed To Investigate How A Radiolabelled Medicine Is Broken Down And Removed From The Body pracinostat - Healthy Subjects | Phase 1 | Completed | Helsinn Healthcare SA | 6 | 2018-02-08 | 2019-08-08 |
| An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia Pracinostat, Placebos, Azacitidine - Acute Myeloid Leukemia | Phase 3 | Terminated | Helsinn Healthcare SA | 406 | 2017-06-23 | 2022-03-10 |
| A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes Pracinostat, Azacitidine - Myelodysplastic Syndromes | Phase 2 | Terminated | Helsinn Healthcare SA | 64 | 2017-06-01 | 2022-03-02 |
| Ruxolitinib and Pracinostat Combination Therapy for Patients With Myelofibrosis (MF) Ruxolitinib, Pracinostat, Questionnaire - Myeloproliferative Diseases | Phase 2 | Completed | M.D. Anderson Cancer Center | 25 | 2015-01-12 | 2019-06-12 |
| Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects Pracinostat, Itraconazole, Ciprofloxacin - Healthy Volunteers, Non-smokers | Phase 1 | Completed | Helsinn Healthcare SA | 32 | 2014-05-01 | 2017-02-23 |
| Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects pracinostat - Healthy Volunteers, Moderate to Heavy Smokers | Early Phase 1 | Completed | Helsinn Healthcare SA | 28 | 2014-02-01 | 2017-02-23 |
| Safety and Efficacy Study of Pracinostat With Azacitadine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Pracinostat, Azacitidine - Acute Myeloid Leukemia | Phase 2 | Completed | Helsinn Healthcare SA | 50 | 2013-12-24 | 2021-02-09 |
| Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA pracinostat, Azacitidine, Decitabine - Myelodysplastic Syndrome, MDS | Phase 2 | Completed | Helsinn Healthcare SA | 45 | 2013-12-01 | 2017-02-23 |
| Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome pracinostat, Placebo, Azacitidine - Myelodysplastic Syndrome | Phase 2 | Completed | Helsinn Healthcare SA | 102 | 2013-06-01 | 2018-09-13 |
| SB939 in Treating Patients With Recurrent or Metastatic Prostate Cancer HDAC inhibitor SB939 - Prostate Cancer | Phase 2 | Completed | NCIC Clinical Trials Group | 32 | 2010-06-28 | 2023-08-04 |
| SB939 in Treating Patients With Locally Advanced or Metastatic Solid Tumors HDAC inhibitor SB939, immunoenzyme technique, immunohistochemistry staining method - Unspecified Adult Solid Tumor, Protocol Specific | Phase 1 | Completed | NCIC Clinical Trials Group | 39 | 2007-09-14 | 2023-08-04 |
Leukemia, Myeloid, Acute (3) · Myelodysplastic Syndromes (3) · Polycythemia Vera (1) · Primary Myelofibrosis (1) · Prostatic Neoplasms (1)
Helsinn Healthcare SA (8) · NCIC Clinical Trials Group (2) · M.D. Anderson Cancer Center (1) · Medical College of Wisconsin (1)
United States (9) · Canada (2) · United Kingdom (2) · Argentina (1) · Australia (1) · Austria (1) · Brazil (1) · Czechia (1) · France (1) · Germany (1) · Hungary (1) · Italy (1) · Poland (1) · Romania (1) · South Korea (1)
Guillermo Garcia-Manero, MD (4) · Terry E O'Reilly, MD (2) · Bernhard Eigl, MD, FRCPC (1) · Ehab Atallah, MD (1) · Kim N. Chi, MD (1) · Lillian L. Siu, MD, FRCPC (1) · Richard Ghalie, MD (1) · Sameem Abedin, MD (1) · Srdan Verstovsek, MD (1)