A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indolent and Smoldering Systemic Mastocytosis with Symptoms Inadequately Controlled with Standard Therapy
Study of Avapritinib (BLU-285) in Patients with Indolent Systemic Mastocytosis (ISM) or Smoldering Systemic Mastocytosis (SSM)
Sponsor: Blueprint Medicines Corporation
Enrolling: Male and Female Patients
IRB Number: AAAS1849
U.S. Govt. ID: NCT03731260
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: This research study is a 3-part, randomized, double-blind study designed to learn more about the safety and effectiveness of an experimental drug called avapritinib (formerly called BLU-285), when given to individuals who have been diagnosed with Indolent Systemic Mastocytosis (ISM) or Smoldering Systemic Mastocytosis (SSM). Experimental means it is not yet known if the drug helps patients, and it is not available for sale. Randomized means that each patient has a random chance (like the flip of a coin) of being assigned to receive one of the treatments being tested during the study, and double-blind means that neither you nor the study doctor will know which one you are taking. Avapritinib is an experimental drug being developed by Blueprint Medicines Corporation to treat all forms of Systemic Mastocytosis (SM). It is an oral drug that is taken once a day continuously in 28-day cycles.
This study is closed
Investigator
Mark Heaney, MD, PhD
Do You Qualify?
Are you 18 years of age or older? Yes No
Do you have systemic mastocytosis with indolent systemic mastocytosis or smoldering systemic mastocytosis subtype? Yes No
Have you ever received avapritinib before? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162