Clinical Trials Using CDA Inhibitor E7727/Decitabine Combination Agent ASTX727
Clinical trials are research studies that involve people. The clinical trials on this list are studying CDA Inhibitor E7727/Decitabine Combination Agent ASTX727. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS
Multicenter, open-label study of various ASTX727 LD doses and schedules to assess safety, pharmacodynamics, pharmacokinetics, and hematologic response in subjects with IPSS risk category of low-risk or Intermediate-1 MDS. This study will be conducted in two phases. In phase 1 subjects will be randomized into 3 cohorts in a 28-day cycles. Phase 2, 80 new subjects will be randomized in a 1:1 ratio into 2 doses / schedules.
Location: 14 locations
A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed / Refractory Acute Myeloid Leukemia (AML)
To evaluate the safety, pharmacokinetics (PK), and efficacy of ASTX660 when given alone and in combination with ASTX727 in participants with relapsed / refractory (R / R) acute myeloid leukemia (AML). The duration of the study is expected to be approximately 30 months.
Location: 8 locations
ASTX727 for the Treatment of IDH Mutant Recurrent Glioma
This phase I trial studies the side effects and best dose of ASTX727 in treating patients with IDH mutant glioma that has come back (recurrent). ASTX727 is made up of the 2 study drugs cedazuridine and decitabine. Cedazuridine may slow down how fast decitabine is broken down by the body. Decitabine may block abnormal cells or tumor cells from growing. This study aims to find the highest dose of ASTX727 that can be administered safely.
Location: 3 locations
ASTX727 for the Treatment of Advanced, Unresectable, or Metastatic Solid Tumors
This phase I trial studies the side effects and best dose of ASTX727 for the treatment of solid tumors that have spread to nearby tissue, lymph nodes, or distant parts of the body (advanced), cannot be removed by surgery (unresectable), or have spread to other places in the body (metastatic). ASTX727 is made up of two investigational drugs. One study drug is oral decitabine, which blocks abnormal cells or tumor cells from growing. The other study drug is called cedazuridine (E7727), which is a cytidine deaminase inhibitor, or CDAi. CDAi slows down how fast the oral decitabine disappears in the body.
Location: 2 locations
Study of ASTX727 vs IV Decitabine in MDS, CMML, and AML
Multicenter, randomized, open-label, crossover PK study of ASTX727 versus IV decitabine. Adult subjects who are candidates to receive IV decitabine will be randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg / m^2 Daily×5 in Cycle 2, or the converse order. After completion of PK studies during the first 2 treatment cycles, subjects will continue to receive treatment with ASTX727 from Cycle 3 onward (in 28-day cycles) until disease progression, unacceptable toxicity, or the subject discontinues treatment or withdraws from the study.
Location: 2 locations
An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)
Extension study for subjects who participated in a previous Astex-sponsored clinical study of ASTX727 (including, but not limited to ASTX727-01, ASTX727-02, ASTX727-04).
Location: 9 locations
ASTX727 and Talazoparib for the Treatment of Triple Negative or Hormone Resistant / HER2-Negative Metastatic Breast Cancer
This phase I trial studies the side effects and best dose of ASTX727 and talazoparib in treating patients with triple negative or hormone resistant / HER2-negative breast cancer that has spread to other places in the body (metastatic). ASTX727 is a combination of two chemotherapy drugs, cedazuridine and decitabine, and may increase the immune system's response to cancer and talazoparib. Talazoparib is an anticancer drug called a PARP (poly ADP ribose polymerase) inhibitor and is in development for the treatment of a variety of cancers. The combination of ASTX727 and talazoparib may help boost the immune system to stop or reverse the growth of tumors.
Location: 2 locations