Overview

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

Status:
Not yet recruiting

Trial end date:
2022-01-01

Target enrollment:

Participant gender:

Summary

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 mg and cedazuridine 100 mg in cancer participants with severe renal impairment and cancer participants with normal renal function as matched control subjects. 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 approximately up to 8 weeks.

Phase:

Phase 1

Details

Lead Sponsor:

Astex Pharmaceuticals, Inc.

Treatments:

Decitabine