Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

Summary

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). 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 this phase 1-3 study is approximately 7 years.

Official Title

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)

Details

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

Keywords

Myelodysplastic Syndromes, Acute Myeloid Leukemia, Myelodysplastic Syndrome/Neoplasm, Chronic Myelomonocytic Leukemia, ASTX030, Myeloid Neoplasm, Hematologic Disease, Leukemia, Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), Vidaza™, Azacitadine, Azacitadine and cedazuridine drug combination, Myeloid Leukemia, Leukemia, Myeloid, Acute, Preleukemia, Leukemia, Myelomonocytic, Acute, Leukemia, Myelomonocytic, Chronic, Leukemia, Myelomonocytic, Juvenile, Syndrome, Azacitidine, ASTX030 (cedazuridine + azacitidine), Cedazuridine

Eligibility

Locations

  • UCI Health - Chao Family Comprehensive Cancer Center not yet accepting patients
    Orange California 92868 United States
  • Keck School of Medicine of USC accepting new patients
    Los Angeles California 90089 United States
  • Oregon Oncology Specialists accepting new patients
    Salem Oregon 97301 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Taiho Oncology, Inc.
ID
NCT04256317
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 235 study participants
Last Updated