Clinical Trials Directory

Trials / Terminated

TerminatedNCT04637009

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

A Phase 1 Study of Safety, Pharmacokinetics and Preliminary Activity of TAS1553 in Subjects With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) and Other Myeloid Neoplasms

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Astex Pharmaceuticals, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGTAS1553Form: tablet; Route of Administration: oral

Timeline

Start date
2020-12-21
Primary completion
2023-02-20
Completion
2023-02-20
First posted
2020-11-19
Last updated
2024-08-02

Locations

10 sites across 2 countries: United States, Canada

Regulatory

Source: ClinicalTrials.gov record NCT04637009. Inclusion in this directory is not an endorsement.