Study on BVD-523FB (Ulixertinib) for Cancers with Specific Genetic Changes

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06400225

This clinical trial is testing the effectiveness of a drug called BVD-523FB (ulixertinib) in treating cancers with certain genetic changes, specifically in a gene called BRAF. The study aims to see if this drug can help slow or stop the growth of cancer cells.

Patient Parameters

Program Overview

This study is exploring how well a drug called BVD-523FB (ulixertinib) works in treating patients with cancer that has specific genetic changes in the BRAF gene. BVD-523FB is a type of medication known as a kinase inhibitor, which works by blocking proteins that signal cancer cells to grow and spread. The goal is to see if this drug can help slow down or stop the spread of cancer cells in patients with these genetic changes.

Description

The main goal of this study is to see how many patients experience a reduction in their cancer with the use of BVD-523FB (ulixertinib). Researchers also want to find out how many patients are still alive and have not seen their cancer progress after six months of treatment. They will also look at how long it takes for the cancer to progress or for the patient to pass away.

Patients in the study will take BVD-523FB (ulixertinib) by mouth twice a day in 28-day cycles. These cycles will continue as long as the cancer does not progress and the patient does not experience unacceptable side effects. Throughout the study, patients will have CT or MRI scans and provide blood samples. They will also have heart function tests and may have biopsies.

After finishing the study treatment, patients will have follow-up visits every three months for two years, and then every six months for one year.

Eligibility Criteria

Inclusion Criteria

  • Must meet eligibility criteria from the main MATCH Protocol before joining this study.
  • Must have a specific type of genetic change in the BRAF gene, but not the V600E/K/R/D mutations.
  • Must have a recent ECG with no significant heart rhythm or structure issues.
  • Must not have allergies to BVD-523FB or related substances.
  • Must have normal heart function.
  • Must not have used similar drugs (MEK or ERK inhibitors) before.
  • Must not have certain eye conditions or high eye pressure.
  • Must not have cancer that has spread to the brain or spinal cord.
  • Must not have a primary brain cancer.

Locations

FACILITYZIPCITYSTATE
ECOG-ACRIN Cancer Research Group19103PhiladelphiaPennsylvania

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