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

Part of paid clinical trials in Houston, Texas.

Sponsor
Taiho Oncology, Inc.
Study ID
NCT04953897
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, 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 severe renal impairment and cancer participants with normal renal function as matched control participants. 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 per participant is approximately up to 8 weeks.

Key Dates

Start date
Dec 15, 2021
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Group A: Severe Renal Impairment
    Cancer participants with severe renal impairment not requiring dialysis (creatinine clearance \[CLcr\] \<30 mL/min/1.73m\^2)
  • Active Comparator: Group B: Normal Renal Function
    Cancer participants with normal renal function (CLcr ≥80 mL/min/1.73m\^2)

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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By specialty
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By research site
MD Anderson· Houston, TX

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