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

Clinical Trial Details

The purpose of the study is to evaluate the potential interaction between an investigational drug combination of ASTX727 and venetoclax, and evaluate the safety and potential benefits when the study drugs are taken together for acute myeloid leukemia (AML). This study will include adults who have newly diagnosed AML who are age 75 years or older, or who have other medical conditions that don’t allow the use of intensive chemotherapy.
   
ASTX727, also known as INQOVI®, is FDA approved for the treatment of patients with myelodysplastic syndrome and chronic myelomonocytic leukemia. ASTX727 is made up of 2 separate drugs that are combined in a single tablet. One drug is called decitabine, which blocks abnormal cells or cancer cells from growing. The other drug is called cedazuridine, which slows down how fast the decitabine disappears in the body, especially in the liver, stomach, and intestines.
   
Venetoclax, also known as Venclexta®, is FDA approved for the treatment of certain patients with chronic lymphocytic leukemia (CLL) and newly diagnosed AML. Venetoclax is a drug that works by stopping cancer cells from surviving beyond when they normally should. 

The combination of ASTX727 and venetoclax is considered investigational, which means that this combination has not yet been approved by the U.S. Food and Drug Administration (FDA) to treat AML.

All participants will receive the study drugs in cycles of 28 days. The study team will discuss the doses and frequency of the study drugs with each participant. Both ASTX727 and venetoclax are taken orally.

Total study participation will last approximately 20 months.

Key Eligibility: 
  1. Participants must be 18 years of age or older.
  2. Confirmation of newly diagnosed acute myeloid leukemia (AML)
  3. Projected life expectancy of at least 3 months.

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Tania J. Curcio, NP, FNP-BC
(212) 746-2571
tjc9003@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2012022983

ClinicalTrials.gov:

NCT04657081

Sponsor:

ASTX727-07

Status

Open to Enrollment

Age Group

Adult

Sponsor