Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment

Recruiting Phase 1 Interventional Study
Acute Myeloid Leukemia Myelodysplastic Syndromes
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
27 (estimated)
Sponsor
Taiho Oncology, Inc. · Industry
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About This Trial
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.…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Able to understand and comply with the study procedures, understand the risks involved in the study, and provide legally effective informed consent before the first study-specific procedure; specifically able to comply with the PK assessment schedule during the first treatment…
Contacts

Taiho Oncology, Inc.

+1 844-878-2446

medicalinformation@taihooncology.com

CONTACT