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NCT01565668 · ClinicalTrials.gov registry record · Phase 2
Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 2 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT01565668: Completed Phase 2 study, sponsored by Daiichi Sankyo.
NCT01565668 is a Phase 2 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01565668, a Phase 2 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
This study will evaluate two doses of Quizartinib in patients with relapsed or refractory acute myeloid leukemia who are also FMS-like tyrosine kinase - internal tandem duplication ( FLT3-ITD) positive. Patient will be randomly assigned in a 1:1 ratio to one of two treatment arms. Both treatment arms will receive Quizartinib but at different doses. The study treatment is taken orally in 28 day cycles until either disease progression occurs or an unacceptable toxicity occurs. In addition to the study assessments to evaluate the disease, blood will be drawn to measure drug levels and biomarkers. Patients will be followed for survival at three month intervals after the end of treatment.
Primary Outcome
CRc is defined as Complete remission (CR) + Complete remission with incomplete platelet recovery (CRp) + Complete remission with incomplete hematological recovery (CRi). * Participants with CR must have normal hematopoietic cells and achieved a morphologic leukemia-free state (\<5% bone marrow blasts in bone marrow, no blasts with Auer rods and no persistence of extramedullary disease) and must have had an absolute neutrophil count (ANC) ≥1 × 10\^9/L and platelet count ≥100 × 10\^9/L and were r
Interventions
- DRUG AC220
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
What the finished NCT01565668 record still lists
NCT01565668 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which AC220 is the first listed.
NCT01565668 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01565668 about?
NCT01565668 is a clinical study titled "Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia". This study will evaluate two doses of Quizartinib in patients with relapsed or refractory acute myeloid leukemia who are also FMS-like tyrosine kinase - internal tandem duplication ( FLT3-ITD) positive. Patient will be randomly assigned in a 1:1 ratio to one of two treatment arms. Both treatment arm...
What is the current status of trial NCT01565668?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2012-04. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01565668?
The interventions under investigation include: AC220 (DRUG).
Who is sponsoring clinical trial NCT01565668?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01565668's enrollment target sits among peer trials
76 893rd of 2000 higher than 1,101 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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