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Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations

NCT04488003 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2024-06-04

Study results available
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Summary

This BVD-523-ABC study builds on the safety and clinical activity experience of previous studies that have evaluated ulixertinib as a novel targeted cancer treatment in cohorts of patients with specific genetic alterations and tumor histologies that result in aberrant MAPK pathway signaling. Early clinical data have demonstrated anti-tumor activity with ulixertinib treatment and have identified specific groups of patients for whom additional development is warranted.

Conditions

  • Advanced Solid Tumor
  • BRAF Gene Mutation
  • BRAF Gene Alteration
  • MEK Mutation
  • MEK Alteration
  • MAP2K1 Gene Mutation
  • MAP2K1 Gene Alteration
  • MAP2K2 Gene Mutation
  • MAP2K2 Gene Alteration

Interventions

DRUG

Ulixertinib

Oral, 600 mg, twice daily, for 28-days in each treatment cycle

DRUG

Physician's Choice

Physician's choice will be restricted to two approved (not off-label) treatments for each tumor histology (agents targeting BRAF or MEK kinases and experimental agents are not permitted as physician choice)).

Sponsors & Collaborators

  • BioMed Valley Discoveries, Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-07
Primary Completion
2023-02-15
Completion
2023-05-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04488003 on ClinicalTrials.gov