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NCT02039726 · ClinicalTrials.gov registry record · Phase 3
(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive
A Phase 3 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 3
- Development phase
- 367
- Enrollment target
NCT02039726: Completed Phase 3 study, sponsored by Daiichi Sankyo.
NCT02039726 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 367 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02039726, a Phase 3 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 367 participants
- Enrollment target
Study Summary
The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.
Primary Outcome
Overall Survival is defined as the time (in weeks) from the date of randomization to the date of death due to any cause. Median and quartiles are calculated using the Kaplan-Meier method.
Interventions
- DRUG Quizartinib
- DRUG Salvage Chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 367 participants |
| Start Date | 2014-05 |
| Est. Completion | 2020-09-08 |
| Phase | Phase 3 |
What the finished NCT02039726 record still lists
NCT02039726 is an interventional study that assigns participants to a tested intervention. The registered 367 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Quizartinib is the first listed.
NCT02039726 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02039726 about?
NCT02039726 is a clinical study titled "(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive". The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months,...
What is the current status of trial NCT02039726?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 367 participants. The study started on 2014-05. Estimated completion is 2020-09-08.
What interventions are being tested in trial NCT02039726?
The interventions under investigation include: Quizartinib (DRUG), Salvage Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT02039726?
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 NCT02039726's enrollment target sits among peer trials
367 998th of 2000 higher than 1,002 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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