ASTX727 + Venetoclax for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+61 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Taiho Oncology, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kim-Hien Dao, DO, PhD

Principal Investigator

Astex Pharmaceuticals, Inc.

Eligibility Criteria

Adults diagnosed with newly identified acute myeloid leukemia (AML) who are either 75 years or older, or between 18 to 74 with certain health issues that make intensive chemotherapy unsuitable. Participants must have a life expectancy of at least three months and be able to give informed consent. Women must not be pregnant and participants should agree to use effective contraception.

Inclusion Criteria

I am not eligible for intensive chemotherapy due to my age or health conditions.

Participants and their partners with reproductive potential must agree to use a highly effective contraceptive measure during the study and for 3 months after the last dose of study treatment, including refraining from sperm donation. Effective contraception includes methods such as oral contraceptives or double-barrier method (eg, use of a condom AND diaphragm, with spermicide)

I am not pregnant or breastfeeding and my pregnancy test was negative.

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Exclusion Criteria

You cannot have eaten grapefruit, grapefruit products, Seville oranges, or starfruit within a week before the start of the trial.

I do not have any major health issues that would affect my participation in the study.

I am allergic to decitabine, cedazuridine, venetoclax, or their ingredients.

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Treatment Details

Interventions

Decitabine and Cedazuridine (ASTX727) (Nucleoside Analog)
Venetoclax (BCL-2 Inhibitor)

Trial OverviewThe trial is testing the combination of ASTX727 (Decitabine and Cedazuridine) with Venetoclax in AML patients. It's designed in two phases: Phase 1 checks for drug interactions, while Phase 2 evaluates how well this combination works against AML.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Oral administration of ASTX727 and Venetoclax combinationExperimental Treatment2 Interventions

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.