Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer P… (NCT04953910) | Clinical Trial Compass
RecruitingPhase 1
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment
United States, Armenia27 participantsStarted 2022-12-23
Plain-language 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 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. A solid tumor that is metastatic or unresectable and for which standard life-prolonging measures are not available.
✓. AML or MDS. or
✓. A hematologic malignancy other than AML or MDS for which standard life-prolonging measures are not available.
✓. Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) or MDS according to the 2008 World Health Organization (WHO) classification; or
✓. Participants with frontline MDS or treatment naïve AML not suitable for induction therapy (e.g., \>75 years, Eastern Cooperative Oncology Group \[ECOG\] performance status ≥2, severe pulmonary disorder, total bilirubin \>1.5X ULN; and
✓. Platelet count ≥25,000/per microliter (μ); and
✕. History or disposition for torsades des pointes (TdP) (e.g., heart failure, hypokalemia, family history of long QT Syndrome).
✕. Concomitant medications that prolong the QT/QTc interval.
✕. Unstable ischemic heart disease or severe heart failure (New York Heart Association Class III or IV).
✕. Uncontrolled treated/untreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure ≥180 millimeters of mercury (mmHg) and/or diastolic blood pressure ≥110 mmHg; current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg).