Trials / Completed
CompletedNCT02984995
Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation
Phase 2 Open-label, Single-arm Study of Quizartinib (AC220) Monotherapy in Japanese Patients With FLT3-ITD Positive Refractory or Relapsed Acute Myeloid Leukemia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Daiichi Sankyo Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2, multi-center, open-label study to evaluate the efficacy, safety and pharmacokinetics of quizartinib monotherapy in Japanese subjects with FLT3-ITD positive refractory or relapsed acute myeloid leukemia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Quizartinib | Quizartinib was orally administered once daily every morning. Treatment with quizartinib was administered in 28-day cycles and continued until the discontinuation criteria for treatment were met. |
Timeline
- Start date
- 2016-12-08
- Primary completion
- 2018-03-28
- Completion
- 2018-09-14
- First posted
- 2016-12-07
- Last updated
- 2020-02-17
- Results posted
- 2020-02-17
Locations
27 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02984995. Inclusion in this directory is not an endorsement.