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Anti-metabolites

Low Dose ASTX727 for Myelodysplastic Syndrome

Q: To what extent is this experiment being conducted by various medical centers?

At present, 26 different medical centres across America are running this trial. This includes Rochester, Québec, and Westwood as well as 23 other cities around the country. It is recommended that patients select a nearby clinic to reduce their travelling needs should they choose to join this clinical study.

Q: Are any new participants being recruited for this medical research?

At the present time, this clinical trial is not accepting applicants. The posting was initially made on July 27th 2018 and was last modified on November 18th 2022. For anyone else looking for available studies, there are 1,592 trials currently recruiting patients with myelodysplastic syndromes and 104 experiments utilising ASTX727 LD that require participants.

Q: For what purposes is ASTX727 LD regularly prescribed?

ASTX727 LD can successfully treat patients with intermediate-2 ipss risk category, individuals identified as having high ipss risk levels, and cases of refractory anemias.

Q: What objectives is this investigation attempting to achieve?

This trial spans 18-24 months and is primarily concerned with the hematologic response, measured by normalizing conversion of any baseline cytopenia or anemia. Secondary objectives include evaluating <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>-free survival, area under a pharmacokinetic curve (AUC), and time to bone marrow blasts >5%.

Phase 1 & 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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18-24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

%LINE-1 methylation change from baseline

Area under the curve (AUC)

Half life (t1/2)

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment2 Interventions

80 additional subjects randomized in a 1:1 ratio studying two different doses

Group II: Phase 1 Stage BExperimental Treatment1 Intervention

3 cohorts of 10 subjects each in 28-day cycles of ASTX727 LD

Group III: Phase 1 Stage AExperimental Treatment1 Intervention

3 cohorts of 6 subjects each in a schedule in 28-day cycles of ASTX727 LD

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Lead Sponsor

95 Previous Clinical Trials

7,801 Total Patients Enrolled

Yuri Sano, MD, PhDStudy DirectorAstex Pharmaceuticals, Inc.

1 Previous Clinical Trials

417 Total Patients Enrolled

Media Library

ASTX727 LD (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03502668 — Phase 1 & 2

Myelodysplastic Syndrome Research Study Groups: Phase 1 Stage A, Phase 1 Stage B, Phase 2

Myelodysplastic Syndrome Clinical Trial 2023: ASTX727 LD Highlights & Side Effects. Trial Name: NCT03502668 — Phase 1 & 2

ASTX727 LD (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03502668 — Phase 1 & 2

Frequently Asked Questions

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

To what extent is this experiment being conducted by various medical centers?

"At present, 26 different medical centres across America are running this trial. This includes Rochester, Québec, and Westwood as well as 23 other cities around the country. It is recommended that patients select a nearby clinic to reduce their travelling needs should they choose to join this clinical study."

Answered by AI

Are any new participants being recruited for this medical research?

"At the present time, this clinical trial is not accepting applicants. The posting was initially made on July 27th 2018 and was last modified on November 18th 2022. For anyone else looking for available studies, there are 1,592 trials currently recruiting patients with myelodysplastic syndromes and 104 experiments utilising ASTX727 LD that require participants."

Answered by AI

For what purposes is ASTX727 LD regularly prescribed?

"ASTX727 LD can successfully treat patients with intermediate-2 ipss risk category, individuals identified as having high ipss risk levels, and cases of refractory anemias."

Answered by AI

What objectives is this investigation attempting to achieve?

"This trial spans 18-24 months and is primarily concerned with the hematologic response, measured by normalizing conversion of any baseline cytopenia or anemia. Secondary objectives include evaluating leukemia-free survival, area under a pharmacokinetic curve (AUC), and time to bone marrow blasts >5%."

Answered by AI

What other investigations have been conducted around the application of ASTX727 LD?

"The first ASTX727 LD clinical trial was conducted in 2004 at Central Illinois Hematology Oncology Center. As of present, 117 studies have finished and 104 are ongoing; many of these trials are occurring within Rochester, Minnesota."

Answered by AI

What is the total enrollment capacity of this clinical experiment?

"This trial has been closed to additional participants as of November 18th, 2022. Those searching for other studies may refer to the 1592 medical trials presently seeking patients with myelodysplastic syndromes and 104 experiments utilizing ASTX727 LD that are still open."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS

2018. "Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03502668.

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