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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: Clinical Trial Phase 1 study, sponsored by Astex Pharmaceuticals.

NCT04637009 is a Phase 1 study that was terminated before completion, run by Astex Pharmaceuticals. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 20 participants
Start Date 2020-12-21
Est. Completion 2023-02-20
Phase Phase 1
Astex Pharmaceuticals

38 total trials

Why NCT04637009 stopped before completion

NCT04637009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 1 intervention - of which TAS1553 is the first listed.

NCT04637009 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04637009's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04637009, the US trial registry maintained by the National Library of Medicine. NCT04637009 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.