Trials / Terminated
TerminatedNCT04282668
A Study of TAS1440 With ATRA in Subjects With r/r AML
A Phase 1 Study of Safety, Pharmacokinetics, and Preliminary Activity of TAS1440, as a Single Agent and in Combination With All-Trans Retinoic Acid (ATRA) in Subjects With Relapsed or Refractory (r/r) Acute Myeloid Leukemia (AML)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Taiho Oncology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | TAS1440 | Form: Capsule or Tablet Route of Administration: Oral |
| DRUG | TAS1440 + ATRA | Form: Capsule or Tablet Route of Administration: Oral |
Timeline
- Start date
- 2020-03-15
- Primary completion
- 2024-02-12
- Completion
- 2024-02-12
- First posted
- 2020-02-25
- Last updated
- 2024-12-09
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04282668. Inclusion in this directory is not an endorsement.