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MEK Inhibitor

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

Gainesville, FL

Phase 2

Waitlist Available

Research Sponsored by BioMed Valley Discoveries, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 25 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment called ulixertinib. Early data shows it could be effective, and this trial is exploring if it could help specific groups of patients with genetic alterations that result in aberrant MAPK pathway signaling.

See full description

Eligible Conditions

Solid Tumors
BRAF Gene Mutation
MAP2K1
MAP2K1 Gene
MAP2K2 Gene

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 25 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 25 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: Overall Response Rate (ORR) According to RECIST 1.1

Secondary study objectives

Part A: Overall Survival (OS) According to RECIST 1.1

Part A: Pharmacokinetic Concentration of BVD-523 at Steady State

Part A: Progression Free Survival (PFS) According to RECIST 1.1

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part B: UlixertinibExperimental Treatment1 Intervention

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

Group II: Part B: Physician's choice of treatmentExperimental Treatment1 Intervention

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). If a patient progresses on physician's choice of treatment, crossover to the ulixertinib arm is permitted.

Group III: Part A: UlixertinibExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ulixertinib

2020

Completed Phase 1

~20

Physician's Choice

2017