6 completed, 4 active not recruiting, 3 recruiting, 3 terminated. 13 Phase 1, 11 Phase 2, 2 Phase 3.
Follow cedazuridine: new trials by email Literature Review of cedazuridine trials Research Report on cedazuridine
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 |
|---|---|---|---|---|---|---|
| Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET, Ivosidenib Oral Tablet, Hydroxyurea - Acute Myeloid Leukemia With Gene Mutations | Phase 2 | Recruiting | PETHEMA Foundation | 50 | 2026-06-12 | 2026-09-22 |
| ASTX727 and Nivolumab in Squamous Cell Carcinoma of the Head and Neck INQOVI (decitabine and cedazuridine), Nivolumab - Recurrent Squamous Cell Carcinoma of the Head and Neck, Metastatic Squamous Cell Carcinoma | Phase 1 | Withdrawn | Case Comprehensive Cancer Center | 2024-06-01 | 2024-07-03 | |
| Eltanexor (KPT-8602) With Inqovi (Decitabine-Cedazuridine) in High-Risk Myelodysplastic Syndromes KPT-8602, Inqovi, Bone marrow aspirate - Myelodysplastic Syndromes | Phase 1 / Phase 2 | Terminated | National Cancer Institute (NCI) | 3 | 2023-11-14 | 2025-12-02 |
| PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes IV Decitabine, Decitabine and cedazuridine, only Decitabine and cedazuridine - Myelodysplastic Syndromes | Phase 1 / Phase 2 | Active not recruiting | Otsuka Beijing Research Institute | 72 | 2023-10-16 | 2026-10-16 |
| Decitabine and Cedazuridine in Combination With Venetoclax for the Treatment of Patients Who Have Relapsed Acute Myeloid Leukemia After Donor Stem Cell Transplant Venetoclax, Decitabine, Cedazuridine - Recurrent Acute Myeloid Leukemia | Phase 2 | Terminated | Sanjay Mohan | 1 | 2023-04-13 | 2026-01-09 |
| Combined Evaluation of Epigenetic and Sensitising Therapy in AML and MDS Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET, Defactinib - Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia | Phase 1 | Recruiting | Clinical Hub for Interventional Research (CHOIR) | 12 | 2022-12-14 | 2026-03-18 |
| BMS-986253 in Myelodysplastic Syndromes Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine, Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine, BMS-986253 - Myelodysplastic Syndromes | Phase 1 / Phase 2 | Terminated | National Cancer Institute (NCI) | 2 | 2022-11-29 | 2025-09-30 |
| Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma Oral Decitabine/Cedazuridine (DEC-C) in Combination with Nivolumab - Malignant Melanoma | Phase 1 / Phase 2 | Completed | University of Colorado, Denver | 8 | 2022-06-20 | 2026-11-09 |
| A Study of Pevonedistat Combined With Decitabine and Cedazuridine in Adults With Higher-risk Myelodysplastic Syndromes Pevonedistat, Decitabine, Cedazuridine - Myelodysplastic Syndromes (MDS) | Phase 2 | Withdrawn | Takeda | 2021-10-01 | 2021-09-29 | |
| Inqovi Maintenance Therapy in Myeloid Neoplasms Inqovi - Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia | Phase 1 | Active not recruiting | Massachusetts General Hospital | 22 | 2021-09-17 | 2026-03-30 |
| Thorough QT Assessment of Cedazuridine in Healthy Subjects Cedazuridine, Placebo, Moxifloxacin - Healthy Volunteers | Phase 1 | Completed | Astex Pharmaceuticals, Inc. | 36 | 2021-07-01 | 2024-08-02 |
| Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML) Decitabine and Cedazuridine (ASTX727), Venetoclax - Acute Myeloid Leukemia | Phase 1 / Phase 2 | Active not recruiting | Taiho Oncology, Inc. | 101 | 2021-02-09 | 2026-10-06 |
| A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) Azacitidine, ASTX030 (cedazuridine + azacitidine), Cedazuridine - Myelodysplastic Syndromes, Acute Myeloid Leukemia | Phase 2 / Phase 3 | Recruiting | Taiho Oncology, Inc. | 316 | 2020-05-21 | 2026-10-06 |
| Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors Decitabine, Cedazuridine - Solid Tumor | Phase 1 | Active not recruiting | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 35 | 2019-04-17 | 2026-09-08 |
| Effect of Food on Blood Levels of ASTX727 ASTX727 + Day 2 Food, ASTX727 + Day 4 Food - Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia | Phase 1 | Completed | Astex Pharmaceuticals, Inc. | 18 | 2018-11-08 | 2024-08-02 |
| Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS ASTX727 LD, ASTX727 SD - Myelodysplastic Syndromes | Phase 1 / Phase 2 | Completed | Taiho Oncology, Inc. | 160 | 2018-07-27 | 2026-04-03 |
| Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML ASTX727, Dacogen - Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia | Phase 3 | Completed | Astex Pharmaceuticals, Inc. | 227 | 2018-02-15 | 2024-08-27 |
| Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS) ASTX727 Dose Escalation, ASTX727 Dose Confirmation, ASTX727 Fixed-Dose Combination - Myelodysplastic Syndrome, MDS | Phase 1 / Phase 2 | Completed | Astex Pharmaceuticals, Inc. | 130 | 2014-10-28 | 2024-08-27 |
Myelodysplastic Syndromes (11) · Leukemia, Myeloid, Acute (7) · Leukemia, Myelomonocytic, Chronic (5) · Anemia, Refractory, with Excess of Blasts (1) · Carcinoma, Squamous Cell (1) · Cytopenia (1) · Hematologic Diseases (1) · Leukemia (1) · Leukemia, Biphenotypic, Acute (1) · Melanoma (1) · Squamous Cell Carcinoma of Head and Neck (1)
Astex Pharmaceuticals, Inc. (4) · Taiho Oncology, Inc. (3) · National Cancer Institute (NCI) (2) · Case Comprehensive Cancer Center (1) · Clinical Hub for Interventional Research (CHOIR) (1) · Massachusetts General Hospital (1) · Otsuka Beijing Research Institute (1) · PETHEMA Foundation (1) · Sanjay Mohan (1) · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (1) · Takeda (1) · University of Colorado, Denver (1)
United States (13) · Canada (5) · Spain (5) · Germany (3) · Italy (3) · Czechia (2) · France (2) · Hungary (2) · United Kingdom (2) · Australia (1) · Austria (1) · Belgium (1) · China (1) · Netherlands (1) · Poland (1)
Najla El Jurdi, M.D. (2) · James Lowder, MD (1) · John Pimanda, Professor (1) · Kyunghee Burkitt, DO, PhD (1) · Martin McCarter (1) · Mohammad Azab, MD (1) · Nilofer Azad, MD (1) · Pau Montesinos (1) · Sanjay Mohan, MD (1) · Zachariah DeFilipp, MD (1)
PMID 30926081, PMID 32285126, PMID 38135371, PMID 42235013
2018 (1)