Study #2021-0880
(SUMMIT) A Multi-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study of The Safety and Efficacy of CGT9486 In Subjects with Nonadvanced Systemic Mastocytosis
MD Anderson Study Status
Not Accepting
Treatment Agent
Bezuclastinib Tablets (Formulation A), Placebo Tablets, Bezuclastinib Tablets (Formulation B)
Description
This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care (BSC) with placebo plus BSC in patients with nonadvanced systemic mastocytosis (NonAdvSM), including indolent systemic mastocytosis and smoldering systemic mastocytosis, whose symptoms are not adequately controlled by BSC. This study will be conducted in three parts. Patients in Parts 1a, 1b and 2 will receive bezuclastinib or placebo, and may roll over onto Part 3 to receive treatment with bezuclastinib.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
SSM, Mastocytosis, Indolent, Mastocytosis, Systemic, Mastocytosis, ISM, BMM, Smoldering Systemic Mastocytosis, Bone Marrow Mastocytosis
Study phase:
Phase II
Physician name:
Prithviraj Bose
Department:
Leukemia
For general questions about clinical trials:
1-877-632-6789
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