(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis

Exclusion Criteria

• •1. Persistent toxicity from previous therapy for NonAdvSM that has not resolved to ≤ Grade 1
• •2. Diagnosed with any of the following WHO SM classifications: bone marrow mastocytosis, advanced systemic mastocytosis including SM with associated hematologic neoplasm, aggressive SM, mast cell leukemia; or mast cell sarcoma
• •3. Diagnosed with mastocytosis of the skin without systemic involvement
• •4. Received prior treatment with any targeted KIT inhibitor with the exception of approved agents for the treatment of SM
• •5. Received prior cytoreductive therapy or investigational agent for \<14 days or 5 half- lives of the drug and for cladribine, interferon alpha, pegylated interferon, or antibody therapy \<28 days or 5 half-lives of the drug (whichever is longer), before starting screening assessments
• •6. Received radiotherapy or psoralen and ultraviolet A therapy \<14 days before starting screening assessments
• •7. Received any hematopoietic growth factor support \<14 days or 5 half lives of the drug before starting screening assessments
• •8. History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study
• •9. Need for treatment of corticosteroids at \>10 mg/day of prednisone or equivalent
• •10. Received strong CYP3A4 inhibitors or inducers within 14 days or 5 drug half-lives before the first dose of study drug