Summit Ph2 CGT9486 in Nonadvanced Systemic Mastocytosis - Clinical Trial
What is the Purpose of this Study?
We are doing this study to figure out how well an investigational drug called CGT9486 (the study drug - also known as bezuclastinib) works in people who are diagnosed with a type of Nonadvanced Systemic Mastocytosis (NonAdvSM). These types are either Indolent Systemic Mastocytosis (ISM) or Smoldering Systemic Mastocytosis (SSM).
Nonadvanced Systemic Mastocytosis (NonAdvSM)
Who Can Participate in the Study?
Adults ages 18+ who are diagnosed with a certain type of Nonadvanced Systemic Mastocytosis (NonAdvSM). The type of NonAdvSM must be either:
- Indolent Systemic Mastocytosis (ISM); OR
- Smoldering Systemic Mastocytosis (SSM)
For more information about who can join this study, please contact the study team at terri.lucas@duke.edu.
What is Involved?
This research study has 3 parts. You may participate in either Part 1 or Part 2, but not both, and Part 3. Whether you participate in Part 1 or Part 2 depends on which part of the study is enrolling, or "open," when you join the study. Your study doctor or staff will let you know which part of the study is open.
If you choose to join this study and participate in Part 1, you will:
- Continue to take your baseline supportive care (BSC) medications as normal
- Make no changes to your BSC medications
- Be assigned to take either the study drug or a placebo (inactive substance)
Part 1 is "blinded," which means neither you nor the study doctor will know if you are taking the study drug or placebo. Study participants assigned to receive the study drug will receive 1 of 3 different dose levels during Part 1. Your chance of getting the study drug in Part 1 is 75%.
If you participate in Part 2, you will:
- Continue to take your BSC medications as normal
- Make no changes to your BSC medications
- Be assigned to take either the study drug or a placebo
Part 2 is also blinded. Study participants assigned to receive the study drug will all get the same dose during Part 2. Your chance of getting the study drug in Part 2 is 67% (2 in 3).
If you finish Part 1 or Part 2, you will have the option to continue to Part 3. There is no placebo used in Part 3, everyone will get the study drug in this part of the study.
If you were in Part 1, you will get the same dose of the study drug in Part 3 that you were assigned to receive in Part 1. If you got placebo in Part 1, then you will get the same dose of the study drug that is used in Part 2.
If you were in Part 2, you will get the same dose of the study drug in Part 3 that is used in Part 2.
Study Details
