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

Part of paid clinical trials in Houston, Texas.

Sponsor
Taiho Oncology, Inc.
Study ID
NCT04953910
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ASTX727 — DRUG
    Multiple-dose oral administration of once-daily decitabine (35 mg) and cedazuridine (100 mg)

Study Details

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.

Key Dates

Start date
Dec 23, 2022
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
27 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group B: Moderate hepatic impairment
    Cancer participants with moderate hepatic impairment \[total bilirubin \>1.5X - 3X upper limit of normal (ULN); any aspartate aminotransferase (AST) level\]
  • Experimental: Group C: Severe hepatic impairment
    Cancer participants with severe hepatic impairment (\>3X ULN; any AST level)
  • Active Comparator: Group A: Normal hepatic function
    Cancer participants with normal hepatic function (total bilirubin ≤ULN; AST ≤ULN)

Primary Outcome Measure

Pharmacokinetic Parameter: 5-day Cumulative Area Under the Concentration-time Curve Within 1 Dosing Interval (AUCtau) [ Time Frame: Predose and at multiple timepoints post-dose from Day 1 to Day 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD AndersonHoustonTexas77030-

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