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Anti-metabolites

Cedazuridine + Azacitidine for Leukemia

Phase 2 & 3
Recruiting
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 with no cytotoxic chemotherapy within 4 weeks before first study treatment.
Able to swallow the number of tablets/capsules required for the treatment assignment within a 10-minute period and tolerate 4 hours of fasting.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial is designed to test a new treatment for leukemia that is taken orally. The first phase will test different doses to find the best one. The second phase will compare the new treatment to the standard one given by injection. The third phase will test the best oral dose against the standard injection dose.

Who is the study for?
This trial is for adults with certain blood disorders like MDS, CMML, or AML who can benefit from azacitidine treatment. They should be physically stable (ECOG 0-1), expected to live at least 12 weeks, able to swallow pills and fast for 4 hours. Pregnant women can't join; participants need proper liver and kidney function and no recent major surgeries or chemotherapy.Check my eligibility
What is being tested?
The study tests ASTX030 (oral cedazuridine combined with azacitidine) against subcutaneous azacitidine alone in three phases: dose escalation, dose expansion, then a randomized comparison of the final oral dose versus the injection form over approximately four years.See study design
What are the potential side effects?
Potential side effects include typical reactions associated with cancer treatments such as nausea, vomiting, diarrhea, constipation, fatigue. There may also be risks related to low blood counts leading to increased infection risk or bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had chemotherapy in the last 4 weeks.
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I can swallow several pills within 10 minutes and fast for 4 hours.
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My liver function tests are within the required range.
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I had a stem cell transplant without GVHD and haven't taken immunosuppressives for 2 weeks.
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I can carry out all my daily activities without help.
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I have MDS, CMML, MDS/MPN, or AML and am a candidate for azacitidine treatment.
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My condition is a specific type of blood disorder according to certain classifications.
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My organs are functioning well.
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I am not pregnant or breastfeeding and my pregnancy test was negative.
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I have not had any major surgery in the last 2 weeks.
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My AML is untreated with 20-30% blasts in my bone marrow.
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My kidneys work well enough to clear waste from my blood.
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I have AML with over 30% blasts in my bone marrow and can't undergo stem cell transplant or intensive chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total cycle area under the curve (AUC)0-24 exposures
Secondary outcome measures
AML-free survival for participants with MDS, CMML, or MDS/MPN
Best clinical response rate for participants with AML
Best clinical response rate for participants with MDS, CMML, or MDS/myeloproliferative neoplasms (MPN)
+10 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Phase 3, Sequence BExperimental Treatment2 Interventions
Participants will receive SC azacitidine in Cycle 1 followed by ASTX030 in Cycle 2; all participants will receive ASTX030 in subsequent cycles (Cycles ≥3)
Group II: Phase 3, Sequence AExperimental Treatment2 Interventions
Participants will receive ASTX030 in Cycle 1, followed by SC azacitidine in Cycle 2; all participants will receive ASTX030 in subsequent cycles (Cycles ≥3)
Group III: Phase 2, Sequence BExperimental Treatment2 Interventions
SC azacitidine will be administered in Cycle 1, followed by oral cedazuridine + azacitidine tablets/capsules in Cycle 2; all participants will receive ASTX030 in subsequent cycles (Cycles ≥3)
Group IV: Phase 2, Sequence AExperimental Treatment2 Interventions
Oral ASTX030 (cedazuridine + azacitidine) will be administered in Cycle 1, followed by SC azacitidine in Cycle 2; all participants will receive ASTX030 in subsequent cycles (Cycles ≥3)
Group V: Phase 1, Stage B (Dose Expansion)Experimental Treatment1 Intervention
Oral cedazuridine + azacitidine will be administered separately at the recommended dose for expansion (RDE)
Group VI: Phase 1, Stage A (Dose Escalation)Experimental Treatment3 Interventions
In Cycle 1 (28 days per cycle), single dose oral azacitidine will be administered, followed by subcutaneous (SC) azacitidine, ASTX030 and oral cedazuridine on a specific dosing schedule; in Cycle 2, oral ASTX030 (cedazuridine + azacitidine) will be administered
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Cedazuridine
2021
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Lead Sponsor
95 Previous Clinical Trials
7,644 Total Patients Enrolled
30 Trials studying Leukemia
3,587 Patients Enrolled for Leukemia

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04256317 — Phase 2 & 3
Leukemia Research Study Groups: Phase 2, Sequence A, Phase 2, Sequence B, Phase 3, Sequence B, Phase 3, Sequence A, Phase 1, Stage A (Dose Escalation), Phase 1, Stage B (Dose Expansion)
Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04256317 — Phase 2 & 3
Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04256317 — Phase 2 & 3

Frequently Asked Questions

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

What are the main indications for ASTX030 (cedazuridine + azacitidine)?

"ASTX030, which is a combination of cedazuridine and azacitidine, can help patients with induction chemotherapy, ipss risk category intermediate-2, and refractory anemias."

Answered by AI

How many people are the researchers investigating in this trial?

"In order for this study to be viable, 317 individuals that meet the pre-determined inclusion criteria must be recruited. The sponsor, Astex Pharmaceuticals, Inc., has set up this trial at multiple locations, such as MD Anderson Cancer Center in Houston, Texas and Roswell Park Comprehensive Cancer Center in Buffalo, New york."

Answered by AI

Are new patients being sought for this research project?

"The clinical trial mentioned is still recruiting patients, with the original posting date being May 21st, 2020. The most recent edit was on October 4th, 2020."

Answered by AI

Are there different sites within the city where this trial is being conducted?

"If you're considering enrolling in this trial, know that there are 7 sites currently recruiting patients.Patients are needed at locations including but not limited to Houston, Buffalo, and Nashville. To limit travel, it is best to select the location nearest to you."

Answered by AI

Are there other examples of research using ASTX030 (cedazuridine + azacitidine)?

"ASTX030 (cedazuridine + azacitidine) is being trialed in 199 separate studies, 34 of which are in Phase 3. The large majority of these are taking place in Saint Louis, Missouri, though there are 5918 locations running these trials in total."

Answered by AI
~96 spots leftby Dec 2025