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Small Molecule

TAS1553 for Acute Myeloid Leukemia

Phase 1

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 33 months

Awards & highlights

Study Summary

This trial is a Phase 1, 2-part study to assess the safety and preliminary clinical activity of TAS1553 in participants with relapsed or refractory acute myeloid leukemia or other myeloid neoplasms.

Eligible Conditions

Acute Myeloid Leukemia
Myelodysplastic/Myeloproliferative Neoplasms
Myeloproliferative Neoplasms

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 33 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 33 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 33 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

Response rate in Cohort 1 (AML): Number of participants with complete response (CR) + complete response with partial hematological recovery (CRh), and with CR + incomplete blood count recovery (CRi) in Part 2

Response rate in Cohort 2 (other myeloid neoplasms): Number of participants with overall response rate (ORR) of CR + partial response (PR) in Part 2

Safety: Number of participants with dose-limiting toxicities in Part 1

+1 more

Secondary outcome measures

Duration of response (DOR): Number of days from the start of response until disease progression or relapse

Hematological improvement: Number of participants in Cohort 2 (other myeloid neoplasms) with hematological improvement in Part 2

Overall survival (OS): Number of days from date of first dose until death due to any cause

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 (dose expansion)Experimental Treatment1 Intervention

Oral administration of TAS1553 once daily at specific time points.

Group II: Part 1 (dose escalation)Experimental Treatment1 Intervention

Oral administration of TAS1553 once daily at specific time points.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Lead Sponsor

95 Previous Clinical Trials

7,941 Total Patients Enrolled

Study DirectorStudy DirectorAstex Pharmaceuticals, Inc.

1,209 Previous Clinical Trials

489,444 Total Patients Enrolled

Jason Taylor, MD PhDStudy DirectorAstex Pharmaceuticals, Inc.

Frequently Asked Questions

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

Are there still available slots for participants in this research?

"As outlined on clinicaltrials.gov, this research initiative is still recruiting participants. The initial posting of the study was made on December 21st 2020 with further amendments being made to it as recently as November 18th 2022."

Answered by AI

What possible risks could arise from the use of TAS1553 in medical treatment?

"Due to limited clinical data, the safety of TAS1553 was rated 1 on a scale from 1-3 by our research team at Power. This is because this trial is in its initial stages and has yet to accumulate evidence regarding efficacy or security."

Answered by AI

How many people have opted to take part in the research?

"Astex Pharmaceuticals, Inc. is recruiting 90 suitable participants to partake in this medical trial across two sites; Norton Cancer Institute (Louisville) and University of Texas MD Anderson Cancer Center (Houston)."

Answered by AI

How many health care settings are administering this trial?

"Nine medical centres, situated in Louisville, Houston and Cleveland amongst other cities are running this trial. Participants should try to pick the closest clinic available to them so as not to be burdened with excessive travel expenses."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of TAS1553 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) and Other Myeloid Neoplasms

2020. "A Study of TAS1553 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) and Other Myeloid Neoplasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04637009.