ASTX030

A Multi-phase, Dose-Escalation Followed by an Open-label, Randomized, Crossover Study of Oral ASTX030 (Cedazuridine and Azacitidine Given in Combination) Versus Subcutaneous Azacitidine in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)

What's the purpose of the trial?

Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a randomized open-label crossover study comparing the final oral ASTX030 dose to SC azacitidine. The duration of the study is expected to be approximately 48 months.
Trial status

Accepting patients

Phase
Phase 2/3
Enrollment
317
Last Updated
1 month ago
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Participating Centers

There are 20 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • ASTX030 is an oral DNMT inhibitor that is a combination of cedazuridine and azacitadine. It's being studied for use in several different indications.
  • Azacitidine is a type of chemotherapy called a hypomethylating agent that interferes with the growth and spread of cancer cells in the body. 
  • Cedazuridine is a type of drug called a CDA inhibitor. When given along with other medicines, Cedazuridine may help them work more effectively in the body.

Arms / Cohorts

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Accepting patients

Phase 1, Stage A (Dose Escalation)

Accepting patients

Phase 1, Stage B (Dose Expansion)

Accepting patients

Phase 2, Sequence A

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