Study of ASTX030 (Cedazuridine and Azacitidine) for MDS, CMML, or AML

Sponsor: Taiho Oncology, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04256317

Provider View

This clinical trial is testing a new treatment, ASTX030, which combines two drugs, cedazuridine and azacitidine, for patients with certain blood cancers like MDS, CMML, or AML. The study will progress through different phases to compare the effectiveness of the oral treatment against the standard subcutaneous treatment.

Patient Parameters

Program Overview

This study is designed to test a new treatment called ASTX030, which combines the drugs cedazuridine and azacitidine, for patients with specific blood cancers such as Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML). The study will move through different phases, starting with testing different doses of the oral treatment, then comparing it to the standard subcutaneous treatment. The study is expected to last about 48 months.

Description

The Phase 1 and Phase 2 arms have completed enrollment. The Phase 3 arm is open for enrollment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with specific types of blood cancers like MDS, CMML, or AML, and eligible for azacitidine treatment.
  • For MDS, must have certain subtypes or risk levels as per medical guidelines.
  • For AML, must have a certain percentage of cancer cells in the bone marrow and not be eligible for stem cell transplant or intensive chemotherapy.
  • Good overall health with a performance status score of 0 or 1.
  • Adequate liver and kidney function based on specific blood tests.
  • No signs of graft-versus-host disease if previously had a stem cell transplant.
  • No major surgery within 2 weeks before starting the study.
  • No chemotherapy within 4 weeks before starting the study.
  • Able to swallow tablets and fast for 4 hours.
  • Expected to live at least 12 more weeks.
  • Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.

Exclusion Criteria

  • Have an active, uncontrolled stomach or intestinal ulcer.
  • Have other serious health conditions or infections that are not controlled.
  • Have a life-threatening illness or medical condition that could affect the study.
  • Have had another cancer, unless it was treated and has been in remission for at least 2 years.
  • Have certain types of blood cancer with disease outside the bone marrow.
  • Have had more than one cycle of certain cancer treatments (for Phases 2 and 3).
  • Have taken an investigational drug or therapy recently.
  • Have allergies to the study drugs or their ingredients.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.