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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
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 moreSecondary 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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding, and I agree to use 2 forms of birth control during and after treatment.My liver and kidney functions are within the required range.I have other serious health issues that are not under control.I do not have any severe illnesses or conditions that could risk my safety in the study.I have been diagnosed with a specific type of blood cancer and cannot undergo intensive chemotherapy.I haven't taken any experimental drugs recently or have ongoing side effects from them.I have a history of HIV or tested positive for hepatitis B or C.I am not on active chemotherapy for another cancer, but may be on hormone therapy for breast or prostate cancer.I am not allergic to decitabine, cedazuridine, or any ingredients in ASTX727 tablets.I have an active stomach or upper small intestine ulcer that's not under control.The investigator thinks that continuing the study treatment may not be safe for you due to other health conditions or organ problems you have or if previous safety data suggests the risks outweigh the benefits.I can take care of myself and am up and about more than half of my waking hours.You have a confirmed diagnosis of -...<br>\nI have had stomach surgery that affects how my stomach moves or absorbs food.I have had chemotherapy for AML, but only hydroxyurea for high WBC counts.I have acute promyelocytic leukemia.I have AML (not type M3) and can't undergo intensive chemotherapy. I may be on HMA treatment.I understand and can follow the study's procedures and risks.
Research Study Groups:
This trial has the following groups:- Group 1: Substudy Arm B: ASTX727 With Low-Calorie/Low-Fat Breakfast Meal on Day 4
- Group 2: Substudy Arm A: ASTX727 With High-Calorie/High-Fat Breakfast Meal on Day 4
- Group 3: Main Extension Study: ASTX727
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Myelomonocytic Leukemia Patient Testimony for trial: Trial Name: NCT04093570 — Phase 2
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