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

StatusRecruiting
PhasePhase 1
Started2022-12-23
View on ClinicalTrials.gov ↗

Amendment history

2026-05-27
Study Status, Contacts/Locations v22
Study sitesdetails revised at 1 of 22 sites
2026-04-29
Study Status, Contacts/Locations v21
Study sitesdetails revised at 5 of 22 sites
2026-03-09
Study Status, Contacts/Locations v20
Study sitesdetails revised at 1 of 22 sites
2026-01-15
Study Status, Outcome Measures, Eligibility v19
Eligibility criteria-251 characters
[...] ule during the first treatment cycle. Participants must have a histologically or cytologically confirmed malignancy as fol [...] which standard life-prolonging measures are not available. or AML or MDS. or A hematologic malignancy other than AML or MDS for which st [...] to the 2008 World Health Organization (WHO) classification; or Participants with frontline MDS or treatment naïve AML not [...] us ≥2, severe pulmonary disorder, total bilirubin >1.5X ULN; and Platelet count ≥25,000/per microliter (μLμ); and Absolute neutrophil count (ANC) ≥100 cells/μL. For particip [...] ML or MDS, or with solid tumors: Platelet cou [...]
Secondary endpoints13 to 15 entries
Pharmacokinetic Parameter: Area Under thePlasma Concentration-time Curve from Time 0Prior to 24 HoursDosing (AUC0-24Ctrough) Pharmacokinetic Parameter: AreaPharmacokinetic UnderParameter: theAUC Concentration-timeWithin Curve1 Dosing Interval (AUCtau) Pharmacokinetic Parameter: AUC From Time 0 Extrapolated to Infinity (AUC0-inf) Pharmacokinetic Parameter: Terminal Elimination Phase Rate Constant (λz)
2025-10-01
Study Status, Contacts/Locations v18
Study sites18→22
Show 17 earlier versions
2025-03-31
Study Status, Contacts/Locations v17
Study sitesdetails revised at 2 of 18 sites
2025-02-28
Study Status, Contacts/Locations v16
Study sites17→18
2025-01-30
Study Status, Contacts/Locations v15
Study sites11→17
2025-01-07
Study Status v14
Primary completion date2024-12→2026-12
Completion date2024-12→2026-12
2024-11-29
Study Status, Contacts/Locations v13
Study sitesdetails revised at 2 of 11 sites
2024-09-11
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v12
Eligibility criteria+178 characters
[...] cipants must have histologically or cytologically confirmed malignancy as follows: A solid tumor or hematologic malignancy that is metastatic or unresectable and for which standard life-prolonging measures are not available. AML or MDS. A hematologic malignancy other than AML or MDS for which standard life-prolonging measures are not available. For participants with AML/MDS only: Cytologically or histolo [...] g to the 2008 World Health Organization (WHO) classification with the disease being refractory, relapsed, or unresponsive to standard treatment; Participants with frontline MDS or treatment naï [...] [...]
Secondary endpoints4 to 13 entries
SafetyPharmacokinetic Parameter: adverseApparent eventsClearance (CL/F) Pharmacokinetic parameterParameter: CmaxRenal Clearance (CLR) Pharmacokinetic parameterParameter: TmaxApparent Nonrenal Clearance (CLNR/F) Pharmacokinetic parameterParameter: Time to Maximum Observed Plasma Concentration (Tmax) Pharmacokinetic Parameter: Maximum Observed Plasma Concentration (Cmax) Pharmacokinetic Parameter: Area Under the Concentration-time Curve from Time 0 (Time of Dosing) to Time t (AUCt) Pharmacokinetic Parameter: Area Under the Concentration-time C [...] AUC0-t24) Pharmacokinetic Parameter: Area Under the C [...]
Primary endpoints1 entry, revised
Pharmacokinetic parameterParameter: 5-day Cumulative Area Under the Concentration-time Curve Within 1 Dosing Interval (AUCtau)
Study sitesdetails revised at 1 of 11 sites
2024-07-31
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 11 sites
2024-07-09
Study Identification, Study Status, Sponsor/Collaborators v10
Lead sponsorAstex Pharmaceuticals, Inc.→Taiho Oncology, Inc.
2024-06-25
3 amendments v7-v9
3 re-verifications since 2024-05-02, no change to tracked fields
2023-08-31
Study Status v6
Start date2022-02-01→2022-12-23
2023-06-29
Study Status, Contacts/Locations v5
Study sites8→11
2022-11-18
Study Status, Contacts/Locations v4
Study sites9→8
2022-07-18
Study Status, Contacts/Locations v3
Start dateestimated 2022-02→confirmed 2022-02-01
Study sites1→9
2022-01-21
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2021-09→2022-02
2021-08-03
Study Status v1
Re-verified, no change to tracked fields
2021-06-30
Original filing
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.
Trial Details
NCT Number NCT04953910
Lead Sponsor Taiho Oncology, Inc.
Conditions Acute Myeloid Leukemia, Myelodysplastic Syndromes
Enrollment 27 participants
Start Date 2022-12-23
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-28