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

Launched by TAIHO ONCOLOGY, INC. · Feb 3, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ASTX030, which combines two medications, cedazuridine and azacitidine, to see how well they work for patients with certain blood disorders, including myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML). The trial is divided into different phases to test the safety and effectiveness of the treatment, starting with small groups of patients and gradually including more participants. The goal is to find out if taking these medications by mouth is as effective as receiving them through an injection under the skin.

To participate in this study, you would need to have a confirmed diagnosis of MDS, AML, or CMML and be eligible for treatment with azacitidine. Key requirements include being between the ages of 65 and 74, having a good performance status, which means you can carry out daily activities without much difficulty, and having adequate organ function. Participants will be monitored throughout the trial to assess how well they respond to the treatment and to check for any side effects. If you or a loved one are interested in this study, it’s a chance to access potentially beneficial treatment while contributing to important medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Phase 2:
• • 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.
• Phase 3:
• 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:
• • a) French-American-British myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and CMML or MDS with intermediate-2 or high risk MDS according to the International Prognostic Scoring System (IPSS).
• • 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.
• Exclusion Criteria:
• Phase 2 and 3:
• • 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.