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Tyrosine Kinase Inhibitor
Bezuclastinib for Systemic Mastocytosis
Phase 2
Recruiting
Research Sponsored by Cogent Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For patients receiving corticosteroids, the dose must be ≤10 mg/day of prednisone or equivalent
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is testing a new drug for people with a mastocytosis, to see if it is safe and effective. The study will have three parts, and patients will either receive the new drug or a placebo.
Who is the study for?
This trial is for patients with a condition called systemic mastocytosis, specifically the indolent or smoldering types. Participants should have moderate-to-severe symptoms despite current treatments and be in fairly good health overall (ECOG 0-2). They can't join if they've had significant bleeding recently, need blood thinners, have certain advanced forms of the disease, skin-only mastocytosis, previous KIT inhibitor therapy (except approved ones), recent cytoreductive therapy or radiation.Check my eligibility
What is being tested?
The study tests bezuclastinib tablets against placebo tablets to see which is better at managing systemic mastocytosis when added to standard care. It's randomized and double-blind meaning neither doctors nor patients know who gets the real drug versus placebo. The trial has three parts; after completing Parts 1a/1b/2 with either drug or placebo, participants may move on to Part 3 for bezuclastinib treatment.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks might include allergic reactions to medication components, potential liver issues since it's processed by the body there, digestive disturbances like nausea or diarrhea as common with oral drugs and possible fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am taking 10 mg or less of prednisone daily or its equivalent.
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I can take care of myself and am up and about more than half of my waking hours.
Select...
I have moderate-to-severe symptoms despite taking at least 2 treatments for 14 days.
Select...
I have been diagnosed with a slow-progressing form of systemic mastocytosis.
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I have been diagnosed with Smoldering systemic mastocytosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Determine recommended dose of bezuclastinib (CGT9486) in subjects with NonAdvSM
Part 2: Efficacy of bezuclastinib at the selected dose versus placebo
Part 3: Safety and tolerability of bezuclastinib as assessed by number of adverse events
Secondary outcome measures
Assess the pharmacokinetics (PK) of bezuclastinib in subjects with NonAdvSM
Change and percent change in 12-item Short Form Health Survey (SF-12)
Change and percent change in EuroQol 5 Dimensions 5 Levels (EQ 5D-5L)
+10 moreTrial Design
9Treatment groups
Experimental Treatment
Placebo Group
Group I: (Part 3) Bezuclastinib + BSCExperimental Treatment2 Interventions
Group II: (Part 2) Bezuclastinib Selected Dose + BSCExperimental Treatment1 Intervention
Group III: (Part 1b) Bezuclastinib Dose 2 + BSCExperimental Treatment1 Intervention
Group IV: (Part 1b) Bezuclastinib Dose 1 + BSCExperimental Treatment1 Intervention
Group V: (Part 1a) Bezuclastinib Dose 2 + BSCExperimental Treatment1 Intervention
Group VI: (Part 1a) Bezuclastinib Dose 1 + BSCExperimental Treatment1 Intervention
Group VII: (Part 2) Placebo + BSCPlacebo Group1 Intervention
Group VIII: (Part 1a) Placebo + BSCPlacebo Group1 Intervention
Group IX: (Part 1b) Placebo + BSCPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Cogent Biosciences, Inc.Lead Sponsor
9 Previous Clinical Trials
760 Total Patients Enrolled
Jessica Sachs, MDStudy DirectorCogent Biosciences
6 Previous Clinical Trials
663 Total Patients Enrolled
Rachael Easton, MD, PhDStudy DirectorCogent Biosciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had radiotherapy or PUVA therapy in the last 14 days.I am taking 10 mg or less of prednisone daily or its equivalent.I can take care of myself and am up and about more than half of my waking hours.I have been treated with a KIT inhibitor, but not for systemic mastocytosis.I have been diagnosed with mastocytosis that affects only my skin.I have been diagnosed with a type of advanced mastocytosis.I have moderate-to-severe symptoms despite taking at least 2 treatments for 14 days.I haven't had serious bleeding or needed blood-thinning medication in the last month.I have been diagnosed with a slow-progressing form of systemic mastocytosis.I have been diagnosed with Smoldering systemic mastocytosis.I haven't had blood cell growth support treatments in the last 2 weeks.I have not had certain cancer treatments for a specific time before screening.I need more than 10 mg/day of prednisone or its equivalent.
Research Study Groups:
This trial has the following groups:- Group 1: (Part 1b) Bezuclastinib Dose 1 + BSC
- Group 2: (Part 2) Bezuclastinib Selected Dose + BSC
- Group 3: (Part 2) Placebo + BSC
- Group 4: (Part 3) Bezuclastinib + BSC
- Group 5: (Part 1a) Bezuclastinib Dose 1 + BSC
- Group 6: (Part 1a) Bezuclastinib Dose 2 + BSC
- Group 7: (Part 1a) Placebo + BSC
- Group 8: (Part 1b) Bezuclastinib Dose 2 + BSC
- Group 9: (Part 1b) Placebo + BSC
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned CGT9486 Tablets for market release?
"Our team has assigned CGT9486 Tablets a score of 2, meaning there is evidence to suggest the drug's safety but not its efficacy thus far."
Answered by AI
How many locations are participating in the implementation of this investigation?
"As of now, 10 different sites are enrolling participants in this trial. These clinical centers can be found in Chicago, Atlanta and Orange City as well as other localities. To reduce the burden of travelling for those involved, it is best to opt for the site nearest you."
Answered by AI
Is enrollment for this research project still open?
"Affirmative. Clinicaltrials.gov states that this clinical trial was first published on October 26th 2021 and has since been updated as of October 19th 2022. There is a need for 138 participants to be recruited from 10 different medical sites."
Answered by AI
How many participants are being enrolled in this clinical investigation?
"Afirmation. The clinical trial entry hosted on the website of clinicaltrials.gov suggests that this research study is presently looking for candidates, having been published on October 26th 2021 and last updated on October 19th 2022. 138 participants are expected to be recruited from 10 distinct medical sites."
Answered by AI
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