Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment
Trial Parameters
Brief Summary
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.
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 cycle. * Participants must have a histologically or cytologically confirmed malignancy as follows: 1. A solid tumor that is metastatic or unresectable and for which standard life-prolonging measures are not available. or 2. AML or MDS. or 3. A hematologic malignancy other than AML or MDS for which standard life-prolonging measures are not available. * For participants with AML/MDS only: 1. Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) or MDS according to the 2008 World Health Organization (WHO) classification or 2. Participants with frontline MDS or treatment naïve AML not suitable for induction therapy (e.g., age \>75 years, Eastern Coop