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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
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
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 moreSecondary 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 moreTrial 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.
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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.
1,230 Previous Clinical Trials
501,070 Total Patients Enrolled
Jason Taylor, MD PhDStudy DirectorAstex Pharmaceuticals, Inc.
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