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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

ECOG (0 to 3)

Diagnosed with one of the following pathologic diagnoses of SM-AHN: Myelodysplastic syndrome (MDS) that is high- or very high-risk, Accelerated phase myeloproliferative neoplasm (MPN), MDS with excessive blasts in bone marrow or peripheral blood, Chronic myelomonocytic leukemia-2 (CMML-2) (High-Risk Cohort)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study Summary

This trial is testing CGT9486, a potential new treatment, for people with a certain type of mastocytosis, which is a disease where too many mast cells build up in the body.

Who is the study for?

This trial is for patients with Advanced Systemic Mastocytosis, including Aggressive SM, SM with an Associated Hematologic Neoplasm, or Mast Cell Leukemia. Participants must have measurable disease and be in a stable enough condition (ECOG 0 to 3). They can't join if they have HIV, hepatitis B/C, other recent cancers, significant heart issues or bleeding events, unresolved toxicity from past treatments or need certain medications like strong CYP3A4 inhibitors.Check my eligibility

What is being tested?

The study is testing Bezuclastinib's effectiveness on Advanced Systemic Mastocytosis. It's an open-label Phase 2 trial where all participants receive the drug. The goal is to see how well it treats different types of this mast cell cancer by monitoring changes in the disease according to specific criteria.See study design

What are the potential side effects?

Potential side effects of Bezuclastinib are not detailed here but may include typical reactions seen with cancer therapies such as nausea, fatigue, blood count changes and increased risk of infections. Specific side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself but may not be able to do heavy physical work.

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I have been diagnosed with a high-risk blood disorder.

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I have been diagnosed with a severe form of mastocytosis.

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I am receiving or need therapy for advanced heart failure.

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My condition worsened while on bezuclastinib, needing urgent treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part I: Identify clinically active and tolerable exposures of bezuclastinib in patients with AdvSM

Part II: - Determine efficacy of bezuclastinib as measured by mIWG Objective Response Rate (ORR) - Confirm the exposure-response relationship of bezuclastinib

Secondary outcome measures

Change from baseline in histopathologic findings in blood and bone marrow

Change in Mastocytosis Activity Score (MAS)

Change in Mastocytosis Quality of Life Questionnaire (MC-QoL)

+12 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: bezuclastinibExperimental Treatment1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cogent Biosciences, Inc.Lead Sponsor

9 Previous Clinical Trials

758 Total Patients Enrolled

Jessica Sachs, MDStudy DirectorCogent Biosciences, Inc.

6 Previous Clinical Trials

661 Total Patients Enrolled

Rachael Easton, MD, Ph.D.Study DirectorCogent Biosciences, Inc.

Media Library

Bezuclastinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04996875 — Phase 2

Systemic Mastocytosis Research Study Groups: bezuclastinib

Systemic Mastocytosis Clinical Trial 2023: Bezuclastinib Highlights & Side Effects. Trial Name: NCT04996875 — Phase 2

Bezuclastinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04996875 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues are supervising this trial?

"The University of Texas MD Anderson Cancer Center in Houston, UCLA Medical Center in Los Angeles, and Galiz Research at Hialeah are just a few of the locations where this research is being conducted. An additional 11 sites have also been identified as suitable for recruitment."

Answered by AI

Has the Food and Drug Administration given the green light to CGT9486 tablets?

"Due to its Phase 2 status, signifying an absence of efficacy data and the presence of safety information, CGT9486 tablets were judged as a level 2 on our risk scale."

Answered by AI

Is registration for this clinical examination still open?

"Affirmative. As reported on clinicaltrials.gov, this investigation was first listed on November 9th 2021 and is still currently recruiting for 140 participants across 11 distinct sites. It has been most recently updated on November 10th 2022."

Answered by AI

What are the chief aims of this clinical experiment?

"The 18 month trial's primary goal is to ascertain the safest dosage of CGT9486 by assessing safety metrics and response parameters. Secondary objectives include gauging Pure Pathologic Response in terms of months, Duration of Response over a similar time-frame, as well as evaluating Pharmacokinetic studies with regards to percentage changes in plasma concentrations."

Answered by AI

What is the aggregate size of this clinical trial's participant pool?

"Indeed, the information from clinicaltrials.gov shows that this medical trial is still actively enrolling volunteers. It was initially established on November 9th 2021 and subsequently updated as recently as November 10th 2022. This research has the capacity to onboard 140 patients across 11 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

2021. "(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04996875.

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