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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
EU CTIS ID: 2022-501427-24-00
What this study is testing
Part 1: To determine the recommended dose of oral bezuclastinib administered in subjects with NonAdvanced Systemic Mastocytosis (NonAdvSM). Part 2: To determine the efficacy of bezuclastinib at the selected dose versus placebo in subjects with NonAdvanced Systemic Mastocytosis. Part 3: To characterize the safety and tolerability of bezuclastinib in subjects with NonAdvanced Systemic Mastocytosis.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosed with 1 of the following diagnoses according to the 2022 World Health Organization (WHO) classification for systemic mastocytosis (SM): 1.Indolent systemic mastocytosis (ISM) 2.Smoldering systemic mastocytosis (SSM) 3.Bone marrow mastocytosis (BMM)
- 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
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
- Other protocol-defined inclusion criteria apply.
You likely can't join if
- Diagnosed with any of the following WHO SM classifications: advanced systemic mastocytosis including SM with associated hematologic neoplasm, aggressive SM, mast cell leukemia; or mast cell sarcoma
- Diagnosed with mastocytosis of the skin without systemic involvement
- History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study
- Need for treatment of corticosteroids at >10 mg/day of prednisone or equivalent
- Other protocol-defined exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Switzerland
- Australia
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Switzerland; Australia; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.