Otsuka Holdings Co., Ltd.: Myelodysplastic Syndromes trials

The registry lists 18 Myelodysplastic Syndromes studies with Otsuka Holdings Co., Ltd. as lead sponsor. 5 are open to participants now and 5 have results posted.

Phase 1 10Phase 2 8Phase 3 5No phase 1(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic ImpairmentRecruitingNCT04953910Phase 1
• Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal ImpairmentRecruitingNCT04953897Phase 1
• A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic SyndromeRecruitingNCT04608110Phase 1
• A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)RecruitingNCT04256317Phase 2/3
• A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)Enrolling by invitationNCT04093570Phase 2
• A Study of Oral Decitabine/Cedazuridine in Combination With Magrolimab in Participants With Intermediate- to Very High-Risk Myelodysplastic Syndromes (MDS)TerminatedNCT05835011Phase 2Results posted
• Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AMLCompletedNCT03306264Phase 3Results posted
• Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAsCompletedNCT02907359Phase 3Results posted
• Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)CompletedNCT02103478Phase 1/2Results posted
• SGI-110 in Participants With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)CompletedNCT01261312Phase 1/2Results posted
• PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic SyndromesActive, not recruitingNCT06091267Phase 1/2
• A Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Myelodysplastic Syndrome, Low-Blast Acute Myeloid Leukemia, or Chronic Myelomonocytic LeukemiaActive, not recruitingNCT05883956Phase 3
• Refine and Assess the Readability of Patient, Carer, and Clinician Treatment Preference in Myelodysplasia QuestionnaireCompletedNCT05817331
• Phase 1 Trial of ASTX727 in Subjects With Lower-risk Myelodysplastic SyndromesActive, not recruitingNCT03906695Phase 1
• Effect of Food on Blood Levels of ASTX727CompletedNCT03813186Phase 1
• Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDSCompletedNCT03502668Phase 1/2
• Study to Assess the Safety of Escalating Doses of AT9283, in Patients With LeukemiasTerminatedNCT00522990Phase 1/2
• Decitabine Versus Supportive Care in Adults With Advanced-stage MDSCompletedNCT00043381Phase 3