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MEK Inhibitor

Physician's Choice for Solid Tumors

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 30 months
Awards & highlights

Study 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.

Eligible Conditions
  • Solid Tumors
  • BRAF Gene Mutation
  • MAP2K1
  • MAP2K1 Gene
  • MAP2K2 Gene

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 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 A: Overall Response Rate (ORR) according to RECIST 1.1
Part B: Progression Free Survival (PFS) according to RECIST 1.1
Secondary outcome measures
Part A: Cmax of BVD-523 at steady state
Part A: Duration of Response (DOR) according to RECIST 1.1
Part A: Overall Survival (OS) according to RECIST 1.1
+4 more

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
Physician's Choice
2017
Completed Phase 3
~1000
Ulixertinib
2020
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

BioMed Valley Discoveries, IncLead Sponsor
16 Previous Clinical Trials
637 Total Patients Enrolled

Frequently Asked Questions

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

What is the aim of this research endeavor?

"This clinical trial, monitored for a maximum of 30 months, is aiming to assess the Progression Free Survival (PFS) according to RECIST 1.1. As secondary objectives, it will evaluate Overall Survival (OS), Duration of Response (DOR) in both Part A and B when compared with physician's choice of treatment using RECIST 1.1 criteria as well; all outcomes are measured until disease progression or death occur or subsequent anticancer therapy begins."

Answered by AI

How many healthcare institutions are administering this experiment?

"This clinical trial is active in 24 locations, including major cities such as Sioux Falls, Phoenix and Boston. It is advisable to choose the closest site so that travel can be kept to a minimum for those who are enrolled."

Answered by AI

Are there any available slots to participate in this investigation?

"Indeed, clinicaltrials.gov records suggest that this trial is still accepting patients since its inception on November 3rd 2020 and last update in August 1st 2022. 528 participants are required to be recruited across 24 different medical centres."

Answered by AI

What is the aggregate count of participants enrolled in this trial?

"Affirmative. According to information on clinicaltrials.gov, the trial initiated on 11/3/2020 and is actively seeking patient enrolments - with a total of 528 needed from 24 different medical centres."

Answered by AI

To what extent is Physician's Choice detrimental to human health?

"There exists some evidence that Physician's Choice is safe, so it was granted a score of 2. As this trial currently resides in Phase 2, there are yet to be any studies demonstrating its efficacy."

Answered by AI

Could you please inform me of any prior research related to Physician's Choice?

"At present, there are 7 live trials for Physician's Choice; none of which have yet to reach Phase 3. Most research sites are located in Salt Lake City, Utah however a total of 1765 locations globally are running studies on this medication."

Answered by AI
Recent research and studies
~22 spots leftby May 2025