Study #2025-0356
A phase 1b, open-label, parallel group, multiple-dose study to evaluate the pharmacokinetics, safety, and tolerability of oral Decitabine and Cedazuridine (ASTX727) in cancer patients with moderate and severe hepatic impairment
MD Anderson Study Status
Enrolling
Treatment Agent
ASTX727
Description
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.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Study phase:
Phase I
Physician name:
Guillermo Garcia-Manero
Department:
Leukemia
For general questions about clinical trials:
1-877-632-6789
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