Spots Global Cancer Trial Database for Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia
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Trial Identification
Brief Title: Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia
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)
Study ID: NCT01565668
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA School of Medicine, Los Angeles, California, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States
John Hopkins University, Baltimore, Maryland, United States
Tufts University School of Medicine-Tufts Medical Center, Boston, Massachusetts, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Hollings Cancer Center, Charleston, South Carolina, United States
Vanderbilt University, Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
UT Southwestern Medical Center, Simmons Cancer Center, Dallas, Texas, United States
MD Anderson, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
CHU d'Angers, Angers, , France
CHU de Grenoble, Grenoble, , France
Hôpital Saint Antoine, Paris, , France
Hôpital Haut Lévêque, Pessac, , France
Universitaria Policlinico S. Orsola Malpighi, Institute of Hemtology "L. & A. Seragnoli", Bologna, , Italy
Nottingham University Hospitals, Nottingham, England, United Kingdom
Contact Details
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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