Spots Global Cancer Trial Database for Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
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Trial Identification
Brief Title: Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Official Title: A Phase 1/2 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory FLT3-ITD Positive Acute Myeloid Leukemia (AML)
Study ID: NCT01349049
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with relapsed or refractory acute myeloid leukemia (AML). Additional dose levels beyond 1200 mg/day may be considered based on safety and efficacy observations.
Detailed Description: Protocol PLX108-05 is a Phase 1/2 open-label, sequential dose escalation (Part 1) followed by cohort expansion (Part 2) design at the recommended phase 2 dose established in Part 1 (i.e. 3,000 mg/day). Treatment with PLX3397 will consist of continuous oral administration in 28-day cycles until unacceptable or dose-limiting toxicity, disease progression or relapse, patient death, Investigator decision, or voluntary withdrawal.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCSF Helen Diller Family Family Comprehensive Cancer Center, San Francisco, California, United States
Northwestern University, Chicago, Illinois, United States
Johns Hopkins University, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
New York Presby Hospital, Weill Medical College at Cornell University, New York, New York, United States
University of Pennsylvania, Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Contact Details
Name: Olga Frankfurt, MD
Affiliation: Robert H. Lurie Comprehensive Cancer Center of Northwestern University - Chicago, IL
Role: PRINCIPAL_INVESTIGATOR
Name: Mark Levis, MD, PhD
Affiliation: Johns Hopkins University
Role: PRINCIPAL_INVESTIGATOR
Name: John Pagel, MD, PhD
Affiliation: Fred Hutchinson Cancer Research Center - Seattle, WA
Role: PRINCIPAL_INVESTIGATOR
Name: Alexander Perl, MD
Affiliation: Hospital of the University of Pennsylvania - Philadelphia, PA
Role: PRINCIPAL_INVESTIGATOR
Name: Gail Roboz, MD
Affiliation: Weill Cornell Medical College/New York Presbyterian Hospital - New York, NY
Role: PRINCIPAL_INVESTIGATOR
Name: Catherine Smith, MD
Affiliation: University of California Medical Center - San Francisco, CA
Role: PRINCIPAL_INVESTIGATOR
Name: Richard Stone, MD
Affiliation: Dana-Farber Cancer Institute - Boston, MA
Role: PRINCIPAL_INVESTIGATOR
Name: Eunice Wang, MD
Affiliation: Roswell Park Cancer Institute - Buffalo, NY
Role: PRINCIPAL_INVESTIGATOR
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