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Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

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Myeloid Leukemia

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All Drugs and Chemicals

Venetoclax

Decitabine

Decitabine and cedazuridine drug combination

Antimetabolites

Enzyme Inhibitors

Cycle 1: ASTX727 according to a prescribed dosing regimen and venetoclax on day 1 (100 mg daily), day 2 (200 mg daily), and days 3-28 (400 mg daily) of a 28-day cycle.

Cycle 2 and beyond: ASTX727 according to a prescribed dosing regimen and venetoclax on days 1-28 (400 mg daily) of a 28-day cycle.

Route of administration: oral in the form of a tablet

Decitabine and Cedazuridine (ASTX727)

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.

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

A Single-Arm, Open-Label Pharmacokinetic, Safety, and Efficacy Study of ASTX727 in Combination With Venetoclax in Adult Patients With Acute Myeloid Leukemia

Venetoclax area under the curve from time 0 to 24 hours (AUC0-24) with and without ASTX727 in Phase 1 and Phase 2, Part A.

Venetoclax maximum observed concentration (Cmax) with and without ASTX727 in Phase 1 and Phase 2, Part A.

Number of participants with CR in Phase 2, Parts A and B.

Decitabine and cedazuridine area under the curve from time 0 to 24 hours (AUC0-24) in Phase 1 and Phase 2, Parts A and B.

Decitabine and cedazuridine maximum observed concentration (Cmax) in Phase 1 and Phase 2, Parts A and B.

Decitabine and cedazuridine area under the curve from time 0 to 8 hours (AUC0-8) in Phase 1 and 2, Parts A and B.

Decitabine and cedazuridine area under the curve from time 0 to infinity (AUC0-inf) in Phase 2, Parts A and B.

Decitabine 5-day cumulative AUC in Phase 1.

Number of participants with treatment-emergent adverse events (TEAEs) in Phase 1 and 2, Parts A and B.

Number of participants with CR (Phase 1), CR + complete response with partial hematological recovery (CRh), and CR + incomplete blood count recovery (CRi) in Phase 1 and 2, Parts A and B.

Number of days from the first dose to the first documented evidence of complete response or CRh in Phase 1 and 2, Parts A and B.

Number of days from the start of response (CR or CRh) until disease progression, start of alternative antileukemia therapy, or death in Phase 1 and 2, Parts A and B.

Number of days from date of first dose until death due to any cause in Phase 1 and 2, Parts A and B.

Venetoclax, decitabine and cedazuridine minimum observed concentration (Cmin) in Phase 1 and Phase 2, Parts A and B.

Venetoclax, decitabine and cedazuridine time to maximum observed concentration in Phase 1 and Phase 2, Parts A and B.

Venetoclax, decitabine and cedazuridine T1/2 in Phase 1 and Phase 2, Parts A and B.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)	NCT04657081	Acute Myeloid L...	Decitabine and ... Venetoclax	18 Years -	Astex Pharmaceuticals, Inc.
Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)	NCT04657081	Acute Myeloid L...	Decitabine and ... Venetoclax	18 Years -	Astex Pharmaceuticals, Inc.
Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)	NCT04657081	Acute Myeloid L...	Decitabine and ... Venetoclax	18 Years -	Astex Pharmaceuticals, Inc.
Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)	NCT04657081	Acute Myeloid L...	Decitabine and ... Venetoclax	18 Years -	Astex Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for decitabine and cedazuridine (astx727)