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

Status
Active
Cancer Type
Hematopoietic Malignancies
Leukemia
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05186753
Protocol IDs
CGT9486-21-202 (primary)
NCI-2022-01167
Study Sponsor
Cogent Biosciences, Inc.

Summary

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.

Eligibility

  1. Diagnosed with 1 of the following diagnoses according to the 2016 World Health Organization (WHO) classification for systemic mastocytosis (SM):
  2. Indolent systemic mastocytosis (ISM), including the bone marrow mastocytosis subvariant
  3. Smoldering systemic mastocytosis (SSM)
  4. Moderate-to-severe symptoms based on a disease-specific PRO and after establishing a stable regimen of at least 2 antimediator therapies over a 14-day eligibility period
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
  6. For patients receiving corticosteroids, the dose must be â?¤10 mg/day of prednisone or equivalent Key

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.