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

NCT04282668 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-12-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TAS1440

Form: Capsule or Tablet Route of Administration: Oral

DRUG

TAS1440 + ATRA

Form: Capsule or Tablet Route of Administration: Oral

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-15
Primary Completion
2024-02-12
Completion
2024-02-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04282668 on ClinicalTrials.gov