Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer P… (NCT04953897) | Clinical Trial Compass
RecruitingPhase 1
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment
United States, Armenia18 participantsStarted 2021-12-15
Plain-language 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.
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., age \>75 years, Eastern Cooperative Oncology Group \[ECOG\] performance ≥2, severe pulmonary disorder, total bilirubin 1.5 × upper limit of normal \[ULN\]); or
✓. Platelet count ≥25,000/per microliter (μL); or
. Corrected QT interval (QTc) using Fridericia's correction (QTcF) at Screening or Day -1 \>470 milliseconds (ms) for males and \>480 ms for females or
✕. History or disposition for torsades des pointes (TdP) (e.g., heart failure, hypokalemia, family history of long QT Syndrome) or
✕. Concomitant medications that prolong the QT/QTc interval
✕. Unstable ischemic heart disease or severe heart failure (New York Heart Association Class III or IV) or
✕. 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).