Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04637009 · ClinicalTrials.gov registry record · Phase 1
A Study of TAS1553 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) and Other Myeloid Neoplasms
A Phase 1 study, sponsored by Astex Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT04637009 is a Phase 1 study that was terminated before completion, run by Astex Pharmaceuticals. The registered enrollment target is 20 participants.
The verdict
NCT04637009, a Phase 1 study, was terminated before completion, sponsored by Astex Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a Phase 1, 2-part, open-label, multicenter, first-in-human (FIH) study to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of TAS1553 administered orally to participants ≥18 years of age with relapsed or refractory (R/R) acute myeloid leukemia (AML) or other myeloid neoplasms where approved therapies have failed or for whom known life-prolonging therapies are not available. The AML population includes de novo AML, secondary AML, and myelodysplastic syndrome (MDS)-transformed into AML. Other myeloid neoplasms include accelerated phase myeloproliferative neoplasms (MPN), and chronic or accelerated phase MPN-unclassifiable (MPN-U) and MDS-MPN. Blast crisis phase of MPNs are considered secondary AML and will be included in the AML cohort. Part 1 is a multicenter, sequential group treatment feasibility study with 1 treatment arm and no masking (dose escalation). Part 2 is a multicenter, two-stage, multiple group, dose confirmation study with 1 treatment arm and no masking (exploratory dose expansion).
Interventions
- DRUG TAS1553
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-12-21 |
| Est. Completion | 2023-02-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04637009
The ClinicalTrials.gov registry entry for NCT04637009 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astex Pharmaceuticals, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TAS1553 is the first listed.
NCT04637009 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04637009 about?
NCT04637009 is a clinical study titled "A Study of TAS1553 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) and Other Myeloid Neoplasms". This is a Phase 1, 2-part, open-label, multicenter, first-in-human (FIH) study to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of TAS1553 administered orally to participants ≥18 years of age with relapsed or refractory (R/R) acute myeloid leukemi...
What is the current status of trial NCT04637009?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-12-21. Estimated completion is 2023-02-20.
What interventions are being tested in trial NCT04637009?
The interventions under investigation include: TAS1553 (DRUG).
Who is sponsoring clinical trial NCT04637009?
This trial is sponsored by Astex Pharmaceuticals, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.