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Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)

StatusActive, Not Recruiting
PhasePhase 1/2
Started2021-02-09
View on ClinicalTrials.gov ↗

Amendment history

2026-08-31
Study Status v41
Re-verified, no change to tracked fields
2025-12-04
Study Status v40
Completion date2025-12-31→2026-12-31
2025-10-01
5 amendments v35-v39
5 re-verifications since 2025-02-28, no change to tracked fields
2025-02-03
Study Status, Study Design v34
Primary completion dateestimated 2024-12-31→confirmed 2024-09-30
Enrollment targetestimated 188→confirmed 101
2025-01-05
4 amendments v30-v33
4 re-verifications since 2024-08-30, no change to tracked fields
Show 29 earlier versions
2024-07-09
Study Identification, Study Status, Sponsor/Collaborators v29
Lead sponsorAstex Pharmaceuticals, Inc.→Taiho Oncology, Inc.
2024-06-25
3 amendments v26-v28
3 re-verifications since 2024-05-02, no change to tracked fields
2024-04-01
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v25
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 34 of 34 sites
2024-01-05
Study Status, Contacts/Locations v24
Study sites33→34
2023-11-30
Study Status, Contacts/Locations v23
Study sitesdetails revised at 1 of 33 sites
2023-09-29
Study Status, Contacts/Locations v22
Study sitesdetails revised at 1 of 33 sites
2023-09-05
Study Status, Contacts/Locations v21
Study sites32→33
2023-08-03
Study Status, Contacts/Locations v20
Study sitesdetails revised at 2 of 32 sites
2023-06-29
Study Status, Contacts/Locations v19
Study sites31→32
2023-05-30
Study Status, Contacts/Locations v18
Study sites30→31
2023-05-19
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v17
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 30 of 30 sites
2023-05-16
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v16
Primary completion date2024-07-28→2024-12-31
Completion date2024-07-31→2025-12-31
Enrollment target124→188
Study sites28→30
Eligibility criteria+31 characters
[...] s of 2 (participants with ECOG ≥3 are not eligible); Phase 2, Parts A and B: ECOG Performance Status of 2 or 3 (participants with ECOG [...] eligible). Phase 1: ECOG Performance Status of 0-2; Phase 2, Parts A and B: ECOG 0-3. Women of child-bearing potential (according to re [...]
Secondary endpoints10 to 13 entries
Pharmacokinetic parameter: Cmin Pharmacokinetic parameter: Tmax Pharmacokinetic Parameter: Apparent Elimination Half-life (T1/2)
2023-04-12
Study Status v15
Primary completion date2023-02-28→2024-07-28
2023-02-16
Study Status, Contacts/Locations v14
Study sites27→28
2022-12-05
Study Status, Contacts/Locations v13
Study sites25→27
2022-11-18
Study Status, Contacts/Locations v12
Study sites24→25
2022-10-05
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v11
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2023-02→2023-02-28
Completion date2024-07→2024-07-31
Study sites16→24
2022-07-29
Study Status, Contacts/Locations v10
Study sites13→16
2022-07-21
Study Status, Contacts/Locations v9
Study sites12→13
2022-04-14
Study Status, Contacts/Locations v8
Study sites10→12
2022-02-23
Study Status, Contacts/Locations v7
Study sites8→10
2022-01-07
Study Status, Contacts/Locations v6
Study sites7→8
2021-09-21
Study Status, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v5
PhasePhase 1→Phase 1/2
Primary completion date2022-09-30→2023-02
Completion date2024-07-31→2024-07
Start date2020-12-31→2021-02-09
Enrollment target34→124
Eligibility criteria+262 characters
[...] h total bilirubin >1.5 to ≤3.0 × upper limit of normal (ULN). , v) Phase 1: Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 (participants with ECOG ≥3 are not eligible); Phase 2: ECOG Performance Status of 2 or 3 (participants with ECOG 4 are not eligible). Phase 1: ECOG Performance Status of 0-2; Phase 2 ECOG 0-3. Women of child-bearing potential (according to recommendat [...] heir partners with reproductive potential must agree to use ata least 2highly effective contraceptive measuresmeasure during the study and for 3 months after the last dose of st [...] a condom AND diaphragm, with s [...]
Secondary endpoints9 to 10 entries
Pharmacokinetic parameter: AUC0-inf Overall ResponseSurvival
Primary endpoints2 to 3 entries
Complete Response (CR)
2021-07-29
Study Status v4
Primary completion date2021-06-30→2022-09-30
Completion date2022-12-31→2024-07-31
2021-06-08
Study Status, Contacts/Locations v3
Study sites5→7
2021-05-26
Study Status, Contacts/Locations v2
Study sites4→5
2021-03-23
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→4
2020-12-01
Original filing
The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax) exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will follow the same overall study design as Phase 1 and has two parts, Part A and Part B. Following study completion, participants who get clinical benefit without unnecessary risks may continue to receive study treatment in the study extension phase.
Trial Details
NCT Number NCT04657081
Lead Sponsor Taiho Oncology, Inc.
Conditions Acute Myeloid Leukemia
Enrollment 101 participants
Start Date 2021-02-09
Primary Completion 2024-09-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-16