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Nucleoside Analog

ASTX727 for Leukemia

Phase 2
Waitlist Available
Research Sponsored by Astex Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have a confirmed diagnosis of- i. MDS including all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, CMML), and participants with MDS International Prognostic Scoring System (IPSS) int-1, -2, or high-risk MD. ii. AML, as diagnosed according to the 2016 World Health Organization (WHO) guidelines on acute leukemia, of any subtype except M3 (acute promyelocytic leukemia), who are not candidates for intensive chemotherapy, including participants receiving hypomethylating agent (HMA) treatment, who have a confirmed diagnosis and a prior confirmatory bone marrow report. Participants who are currently receiving HMA treatment must complete the ongoing (at the time of Screening) treatment cycle before enrolling in this study; timing of start of treatment cycle with ASTX727 is at the principal investigator's discretion.
Adequate organ function defined as follows: Hepatic: Total bilirubin ≤1.5 × upper limit of normal (ULN); aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) ≤5 × ULN. Renal: Calculated creatinine clearance ≥60 mL/min.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights

Study Summary

This trial is an extension of a previous study that found benefits from ASTX727 treatment. The purpose of the Food Effect Substudy is to study the effects of food on the drug's safety and how it is absorbed by the body.

Who is the study for?
This trial is for people who have certain types of leukemia or preleukemia and were previously benefiting from ASTX727 in an Astex-sponsored study. They must understand the study, not be pregnant or breastfeeding, use effective birth control, have a performance status of 0 to 2 (which measures how the disease affects daily living abilities), and adequate liver and kidney function.Check my eligibility
What is being tested?
The trial continues treatment with ASTX727 for those who benefited from it before. It also studies how food affects the drug's absorption and safety by comparing its effects when taken with different meals versus no meal at all.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions related to ASTX727 which could include typical chemotherapy-related issues such as digestive problems, blood disorders, fatigue, or potential organ dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a specific type of blood cancer and cannot undergo intensive chemotherapy.
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My liver and kidney functions are within the required range.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Food Effect Substudy: AUC 0-inf: Area Under the Concentration-time Curve From Time Zero to Infinity of Cedazuridine in the Fasted and Fed State
Food Effect Substudy: AUC 0-inf: Area Under the Concentration-time Curve From Time Zero to Infinity of Cedazuridine-epimer in the Fasted and Fed State
Food Effect Substudy: AUC 0-inf: Area Under the Concentration-time Curve From Time Zero to Infinity of Decitabine in the Fasted and Fed State
+19 more
Secondary outcome measures
Food Effect Substudy: Percentage of Participants with Clinically Significant Abnormal Laboratory Values
Therapeutic procedure
Main Extension Study: Number of Participants with Solid Tumors with Disease Status: Complete Response (CR), Partial Response (PR), Stable Disease (SD)
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Substudy Arm B: ASTX727 With Low-Calorie/Low-Fat Breakfast Meal on Day 4Experimental Treatment1 Intervention
Participants will receive ASTX727 once daily on Days 1 through 5 in a 28-day cycle (Cycle 1). Participants will fast for at least 2 hours before and 2 hours after dosing on Days 1, 3, 5 and for at least 10 hours before and 4 hours after dosing on Day 2. Participants will receive low-calorie/low-fat breakfast meal after an overnight fast of at least 10 hours before dosing on Day 4 and will continue to fast for at least 4 hours post-dose. Participants will continue treatment with ASTX727 in Cycle 2 onwards in the ASTX727-06 study at the Investigator's discretion, where they will continue to receive ASTX727 unless there is occurrence of disease progression requiring alternative therapy, unacceptable toxicity, noncompliance, a decision to discontinue treatment, or if the participant withdraws from the study.
Group II: Substudy Arm A: ASTX727 With High-Calorie/High-Fat Breakfast Meal on Day 4Experimental Treatment1 Intervention
Participants will receive ASTX727 once daily on Days 1 through 5 in a 28-day cycle (Cycle 1). Participants will fast for at least 2 hours before and 2 hours after dosing on Days 1, 3, 5 and for at least 10 hours before and 4 hours after dosing on Day 2. Participants will receive a high-calorie/high-fat breakfast meal after an overnight fast of at least 10 hours before dosing on Day 4 and will continue to fast for at least 4 hours post-dose. Participants will continue treatment with ASTX727 in Cycle 2 onwards in the ASTX727-06 study at the Investigator's discretion, where they will continue to receive ASTX727 unless there is occurrence of disease progression requiring alternative therapy, unacceptable toxicity, noncompliance, a decision to discontinue treatment, or if the participant withdraws from the study.
Group III: Main Extension Study: ASTX727Experimental Treatment1 Intervention
The recommended starting dose is the fixed-dose combination (FDC) tablet, containing 100 mg cedazuridine and 35 mg decitabine, once daily, Days 1 through 5 in 28-day cycles. Participants should receive ASTX727 at the same dose they received in the last cycle of their parent study; if an adjustment from that dose is required, a different total cycle dose may be employed, as guided by the dose adjustment guidelines in the parent study protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASTX727
2018
Completed Phase 3
~240

Find a Location

Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Lead Sponsor
95 Previous Clinical Trials
7,629 Total Patients Enrolled
Yuri SanoStudy DirectorAstex Pharmaceuticals, Inc.

Media Library

ASTX727 (Nucleoside Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04093570 — Phase 2
Chronic Myelomonocytic Leukemia Research Study Groups: Substudy Arm A: ASTX727 With High-Calorie/High-Fat Breakfast Meal on Day 4, Substudy Arm B: ASTX727 With Low-Calorie/Low-Fat Breakfast Meal on Day 4, Main Extension Study: ASTX727
Chronic Myelomonocytic Leukemia Clinical Trial 2023: ASTX727 Highlights & Side Effects. Trial Name: NCT04093570 — Phase 2
ASTX727 (Nucleoside Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04093570 — Phase 2
Chronic Myelomonocytic Leukemia Patient Testimony for trial: Trial Name: NCT04093570 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does ASTX727 compare to other treatments in terms of safety?

"While Phase 2 trials don't have efficacy data, the existing safety data for ASTX727 led our team to rate it a 2."

Answered by AI

For what purpose is ASTX727 most often employed?

"ASTX727 is most commonly given to patients who fall into the ipss risk category intermediate-2, but it can also be used as a treatment for refractory anemias, anemia, and high risk ipss."

Answered by AI

In how many different medical facilities is this research being conducted today?

"The trial is based in Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Center located in Seattle, WA. Additionally, there are two other centres in Plantation, Florida and Dallas, Texas. Finally, there are 23 other clinical sites spread out across the United States of America."

Answered by AI

How many people fit the screening criteria for this clinical trial?

"Unfortunately, this specific trial is not currently recruiting patients. However, there are 1715 other trials for myelodysplastic syndromes and 108 studies for ASTX727 that are both actively enrolling participants."

Answered by AI

Is recruitment still underway for this research project?

"As indicated on clinicaltrials.gov, this trial is not currently recruiting patients. The study was first posted on 30 September 2019 and was last updated on 5 October 2022. Although this particular study is no longer looking for participants, there are 1,823 other studies that are presently recruiting patients."

Answered by AI

What are the previous findings from research on ASTX727?

"ASTX727 was first studied over 16 years ago.117 trials have completed and there are 108 live studies as of now. A large concentration of these ongoing ASTX727 trials are based in Seattle, Washington."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
What site did they apply to?
Hackensack Medical Center - 06 FE Study

What questions have other patients asked about this trial?

What personal expense might I expect over and above medicare and supplement?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I SUFFER FROM DEPRESSION AND I WAS PRESCRIBE AND ANTI=DEPRESSION MEDICATION.
PatientReceived 2+ prior treatments
I am proactive in seeking a cure for my low grade MDS. I am anemic, short of breath and energy and striving for better life quality. I am told that I will eventually become refractory to any treatment and die of my disease.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
2019. "A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04093570.
All > Acute Myeloid Leukemia > Myelodysplastic Syndrome
~42 spots leftby Dec 2024
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