A Phase 1 interventional study of ASTX727 + Day 2 Food and ASTX727 + Day 4 Food in Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Acute Myeloid Leukemia, sponsored by Astex Pharmaceuticals, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-02.
Sponsored by Astex Pharmaceuticals, Inc. · Phase 1, Interventional, and Basic science
This study is designed to examine blood levels of ASTX727, a fixed-dose combination tablet containing the combination of cedazuridine (100 mg) and decitabine (35 mg), when given under fed versus fasted conditions to participants with myelodysplastic syndromes (MDS), including refractory anemia with excess blasts in transformation or chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML). This study will also assess the safety of ASTX727.
This is a Phase 1b, multicenter, open-label, randomized, two-sequence, crossover study of ASTX727 in participants with MDS, including refractory anemia with excess blasts in transformation or CMML, and AML. Participants will continue to be enrolled until evaluable data is collected from 12 participants. It is expected that approximately 18 participants will be enrolled in total.
This study will be conducted in 28-day cycles. All participants will take part in Cycle 1 and may continue into Cycles ≥2 at the investigator's discretion. Participants will receive one tablet of ASTX727 containing 100 mg cedazuridine and 35 mg decitabine once daily for 5 days in 28-day cycles starting from Cycle 1 Day 1.
Participants will be randomized in a 1:1 ratio to receive high-calorie, high-fat breakfast meal pre-dose on either Day 2 or Day 4 of Cycle 1. Blood will be drawn at specified time points in Cycle 1 on Days 2 through 5 to assess the effect of food on the PK of cedazuridine and decitabine.
After completion of the first treatment cycle, participants may continue to receive treatment with ASTX727 at the investigator's discretion for subsequent cycles (Days 1 through 5 of 28-day cycles), until disease progression, unacceptable toxicity, investigator decision to discontinue treatment, or the participant decides to discontinue treatment or withdraw from the study. In Cycles ≥2, participants will fast for 2 hours before and 2 hours after taking the ASTX727 tablet on all dosing days.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 18 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Astex Pharmaceuticals, Inc. is the lead sponsor of 42 studies on the registry; none are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 6 (46%) have results posted.
Counted across the registry records on this site, refreshed daily.
Men or women ≥18 years with either:
Adequate organ function defined as follows:
Exclusion Criteria:
Subjects will receive ASTX727 on Days 1-5 of Cycle 1 and a high-calorie, high-fat breakfast meal of 800-1000 calories pre-dose on Day 2 of Cycle 1.
Drug: ASTX727 + Day 2 Food
Subjects will receive ASTX727 on Days 1-5 of Cycle 1 and a high-calorie, high-fat breakfast meal of 800-1000 calories pre-dose on Day 4 of Cycle 1.
Drug: ASTX727 + Day 4 Food
ASTX727 is an oral drug product composed of a fixed-dose combination of cedazuridine (E7727), a CDA inhibitor, and decitabine. Food is a high-calorie, high-fat breakfast meal of 800-1000 calories given on Day 2.
Also known as: cedazuridine + decitabine + food on Day 2
ASTX727 is an oral drug product composed of a fixed-dose combination of cedazuridine (E7727), a CDA inhibitor, and decitabine. Food is a high-calorie, high-fat breakfast meal of 800-1000 calories given on Day 4.
Also known as: cedazuridine + decitabine + food on Day 4
AUC0-t (area under the concentration-time curve from time 0 to t hours).
Area under the concentration-time curve from time 0 to t hours.
Time frame: 6 months
AUC0-8 (area under the concentration-time curve from time 0 to 8 hours).
Area under the concentration-time curve from time 0 to 8 hours.
Time frame: 6 months
AUC0-24 (area under the concentration-time curve from time 0 to 24 hours).
Area under the concentration-time curve from time 0 to 24 hours
Time frame: 6 months
AUC0-inf (area under the concentration-time curve from time 0 to infinity).
Area under the concentration-time curve from time 0 to infinity.
Time frame: 6 months
Cmax (maximum plasma concentration).
Maximum plasma concentration.
Time frame: 6 months
hemoglobin level
Assessed in g/dL
Time frame: 6 months
platelet count
Assessed as 10\^9/L
Time frame: 6 months
white blood cell count
Assessed as fraction of 1
Time frame: 6 months
neutrophils
Assessed as percent
Time frame: 6 months
Subject-reported and investigator-observed incidence and severity of adverse events.
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Astex Pharmaceuticals, Inc.