Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT01565668. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects With FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01565668
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 76 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2012 (Type not available)
- Primary completion
- Mar 2015 (Actual)
- Completion
- Mar 2015 (Actual)
- Last update posted
- Dec 27, 2019
2012 – 2015
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA School of Medicine | Los Angeles | California | 90095 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| University of Maryland Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| John Hopkins University | Baltimore | Maryland | 21231 | — |
| Tufts University School of Medicine-Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina, Hollings Cancer Center | Charleston | South Carolina | 29403 | — |
| Vanderbilt University, Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| UT Southwestern Medical Center, Simmons Cancer Center | Dallas | Texas | 75390 | — |
| MD Anderson | Houston | Texas | 77030 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01565668, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 27, 2019 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01565668 live on ClinicalTrials.gov.