A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML

Description

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.

Conditions

Myelodysplastic Syndromes, Acute Myeloid Leukemia, Myelodysplastic Syndrome/Neoplasm, Chronic Myelomonocytic Leukemia

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Study Overview

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Study Details

Study overview

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.

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)

A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML

Condition
Myelodysplastic Syndromes
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Keck School of Medicine of USC, Los Angeles, California, United States, 90089

New Haven

Yale University, New Haven, Connecticut, United States, 06510

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02114

Hackensack

John Theurer Cancer Center / Hackensack University, Hackensack, New Jersey, United States, 07601

Buffalo

Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States, 14263

Mineola

New York University Langone Hospital - Long Island, Mineola, New York, United States, 11501

New York

Perlmutter Cancer Center - 34th Street, New York, New York, United States, 10016

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

New York

Weill Cornell Medical Center, New York, New York, United States, 10065

Durham

Duke University, Durham, North Carolina, United States, 27705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Has Confirmed MDS, CMML, MDS/MPN or AML diagnosis who are candidates to receive and benefit from single agent azacitidine and as applicable according to local country approvals and/or local institution standard practice.
  • 1. Has confirmed MDS or CMML and is a candidate to receive and benefit from single agent azacitidine as applicable according to local country approvals and/or local institution standard practice:
  • 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • 3. Participants with adequate organ function.
  • 4. For participants with prior allogeneic stem cell transplant, no evidence of graft-versus-host disease (GVHD).
  • 5. Participants with no major surgery within 3 weeks before first study treatment.
  • 6. Participants with no cytotoxic chemotherapy (excluding hydroxyurea) within 4 weeks before first study treatment.
  • 7. Participants with projected life expectancy of at least 12 weeks.
  • 1. Has an active uncontrolled gastric or duodenal ulcer.
  • 2. Has poor medical risk because of other conditions.
  • 3. Has known human immunodeficiency virus (HIV) infection.
  • 4. Is known to be positive for Hepatitis B or C infection.
  • 5. Has a life-threatening illness.
  • 6. Has a history of other malignancies prior to study entry, with the exception of adequately treated in situ carcinoma of the breast or cervix uteri; localized basal cell carcinoma or squamous cell carcinoma of the skin; previous malignancy confined and surgically resected or adequately treated and controlled with other modalities; and any early stage malignancy for which no definitive therapy is required.
  • 7. Participants with MDS/MPN including CMML who have clinical extramedullary disease including clinically palpable hepatomegaly or splenomegaly.
  • 8. Has previous treatment with more than 1 cycle of decitabine, azacitidine, or guadecitabine (Phases 2 and 3 only).
  • 9. Has been treated with any investigational drug or therapy within 2 weeks, or 5 half-lives, whichever is longer, before the protocol-defined first dose of study treatment, or ongoing clinically significant adverse events from previous treatment with investigational drug or therapy.
  • 10. Has a known or suspected hypersensitivity to cedazuridine or azacitidine or any of their excipients.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Taiho Oncology, Inc.,

Study Record Dates

2028-05-01