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Anti-metabolites

Low Dose ASTX727 for Myelodysplastic Syndrome

Phase 1 & 2

Waitlist Available

Research Sponsored by Taiho Oncology, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have had at least 1 of the following disease-related criteria during the 8 weeks before randomization: Red blood cell (RBC) transfusion dependence of 2 or more units of RBC transfusions, Hb of <9.0 g/dL in at least 2 blood counts prior to randomization or in 1 blood count if RBC transfusion was received, Absolute Neutrophil Count (ANC) of <0.5 × 10^9/L in at least 2 blood counts prior to randomization, Platelet counts of <50 × 10^9/L in at least 2 blood counts prior to randomization, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, Adequate organ function, Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening, Women of child-bearing potential must agree to use contraceptive measures of birth control for 6 months after completing treatment; men must use contraceptive measures and agree not to father a child for at least 3 months after completing treatment

Men or women ≥18 years with IPSS low risk or Int-1 MDS

Must not have

Prior treatment with azacitidine, decitabine, or guadecitabine

Known active infection with human immunodeficiency virus or hepatitis viruses

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18-24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing different doses and schedules of a drug called ASTX727 to see how well it works and how safe it is in patients with a type of blood cancer called myelodysplastic syndrome.

Who is the study for?

This trial is for adults with low-risk or Intermediate-1 Myelodysplastic Syndrome who have specific blood count criteria, can follow study procedures, and are not pregnant. They must agree to use birth control during and after the trial. People with certain other conditions or treatments, like recent investigational drugs or prior malignancies (with some exceptions), cannot join.

What is being tested?

The study tests different doses of ASTX727 LD in people with MDS over two phases: Phase 1 randomizes participants into three groups for a 28-day cycle; Phase 2 involves 80 new subjects split evenly between two dose schedules to evaluate safety and effectiveness.

What are the potential side effects?

While specific side effects are not listed here, common ones may include reactions at the drug administration site, gastrointestinal issues, fatigue, blood cell changes affecting immunity or clotting, liver function alterations, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older with low to intermediate-1 risk MDS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with azacitidine, decitabine, or guadecitabine before.

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I do not have an active HIV or hepatitis infection.

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I have been diagnosed with chronic myelomonocytic leukemia.

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I have other serious health issues that are not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18-24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18-24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18-24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hematologic response based on normalization of conversion of any baseline cytopenia or anemia (hemoglobin response, neutrophil response, platelet response, transfusion independence)

Incidence of drug-related Grade ≥3 Adverse Events (AEs) or dose-limiting toxicities (DLTs) (if any) for each cohort dose/schedule

Secondary study objectives

%LINE-1 methylation change from baseline

Area under the curve (AUC)

Half life (t1/2)

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