drugset / Trial / NCT04282668

A Study of TAS1440 With ATRA in Subjects With r/r AML

NCT04282668 ↗

Phase 1 Terminated 52 enrolled Taiho Oncology, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a multicenter, 2-part, Phase 1 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of TAS1440 administered as a single agent and in combination with all-trans retinoic acid (ATRA) in participants with acute myeloid leukemia (AML) who have relapsed or are refractory (r/r) to prior treatment. The study duration is expected to be approximately 30 months.

Timeline

Start
2020-03-15
Primary completion
2024-02-12
Completion
2024-02-12

Outcome

Outcome not reported

Stopped (Enrollment): “The study was terminated due to the changing treatment landscape, difficulty in enrolling eligible participants, and little likelihood of providing meaningful clinical benefit for the participants.”

Drugs

EvaluationDrugModalityDoseRoute
Subject TAS1440 Unknown — Oral
Subject Tretinoin Unknown — Oral