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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
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
Completed Phase 3
~1000
Find a Location
Closest Location:Kettering Cancer Center· Kettering, OH· 65 miles
Who is running the clinical trial?
BioMed Valley Discoveries, IncLead Sponsor
18 Previous Clinical Trials
542 Total Patients Enrolled