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

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 enrollme

Trial Details

NCT ID
NCT04953910
Phase
PHASE1
Sponsor
Taiho Oncology, Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • ASTX727
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327
  • Yerevan, Armenia|40.17765,44.5126
  • Yerevan, Armenia|40.17765,44.5126
  • Yerevan, Armenia|40.17765,44.5126
  • Yerevan, Armenia|40.17765,44.5126

Key Eligibility Criteria

  • Able to understand and comply with the study procedures, understand the risks involved in the study, and provide legally effective informed consent…
  • Participants must have a histologically or cytologically confirmed malignancy as follows:
  • A solid tumor that is metastatic or unresectable and for which standard life-prolonging measures are not available.
  • AML or MDS. or

For full eligibility, visit ClinicalTrials.gov.

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