Condition: Acute Myeloid Leukemia · Myelodysplastic Syndromes · Sponsor: Taiho Oncology, Inc.
This is a Phase 1b, multicenter, open-label, pharmacokinetic (PK), and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams (mg) and cedazuridine 100 mg in cancer participants with moderate and severe hepatic impairment and cancer participants with normal hepatic function as control participants. Participants with severe hepatic impairment will be enrolled only after the safety evaluation of at least 6 participants with moderate hepatic impairment has been determined and supports the enrollment of participants with severe hepatic impairment. Adult participants with acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), or solid tumors who are candidates to receive oral decitabine and cedazuridine will be enrolled in this study. Study duration is per participant approximately up to 8 weeks.
This description comes directly from the study's public registry record.
Taiho Oncology, Inc. · +1 844-878-2446 · medicalinformation@taihooncology.com
Always discuss trial participation with your own doctor first.
| MD Anderson | Houston, Texas, United States | Recruiting |
| Erebuni Medical Center | Yerevan, Armenia | Recruiting |
| Hematology Center After Prof. R. Yeolyan (Adult Blood Disorders) | Yerevan, Armenia | Recruiting |
| Hematology Center After Prof. R. Yeolyan (Clinic of Adults Oncology) | Yerevan, Armenia | Recruiting |
| National Center of Oncology Named After V.A. Fanarjyan | Yerevan, Armenia | Recruiting |
| Complex Oncology Center - Plovdiv - Base II | Plovdiv, Bulgaria | Withdrawn |
| BIO1 | Vilnius, Lithuania | Withdrawn |
| Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p. | Wroclaw, Poland | Recruiting |
| Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu | Bucharest, Romania | Recruiting |
| Institutul Oncologic Prof. Dr. Ion Chiricuta | Cluj-Napoca, Romania | Recruiting |
| Summit Clinical Research s.r.o | Bratislava, Slovakia | Recruiting |
| START Barcelona - Hospital HM Nou Delfos | Barcelona, Spain | Recruiting |
+ 10 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04953910