MEK-1/MEKK-1 Inhibitor E6201 for Cancer, Second Primary

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Florida, Jacksonville, FL
Cancer, Second Primary+6 More
MEK-1/MEKK-1 Inhibitor E6201 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the safety and effectiveness of two drugs, E6201 and dabrafenib, for patients with melanoma that has spread to the brain. The MEK-1/MEKK-1 Inhibitor E6201 is being used to treat cancer as well as a second primary. In this trial, there will be no placebo given to any of the patients. The treatment is free of charge. The MEK-1/MEKK-1 Inhibitor E6201 has been approved by the FDA in the past for a different condition.

Eligible Conditions

  • Cancer, Second Primary
  • Brain
  • Metastatic Malignant Neoplasm in the Central Nervous System
  • Cutaneous Melanoma
  • Metastatic Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cancer, Second Primary

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
BRAF mutational status
Incidence of adverse events
Overall extracranial response rate
Overall intracranial response rate
Overall survival
Time to first progression
Day 28
Maximum tolerated dose

Trial Safety

Safety Progress

1 of 3

Other trials for Cancer, Second Primary

Trial Design

1 Treatment Group

Treatment (E6201, dabrafenib)
1 of 1
Experimental Treatment

18 Total Participants · 1 Treatment Group

Primary Treatment: MEK-1/MEKK-1 Inhibitor E6201 · No Placebo Group · Phase 1

Treatment (E6201, dabrafenib)Experimental Group · 2 Interventions: Dabrafenib, MEK-1/MEKK-1 Inhibitor E6201 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dabrafenib
2011
Completed Phase 3
~3090

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Closest Location: Mayo Clinic in Florida · Jacksonville, FL
Photo of Jacksonville 1Photo of Jacksonville 2Photo of Jacksonville 3
2013First Recorded Clinical Trial
0 TrialsResearching Cancer, Second Primary
182 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,937 Previous Clinical Trials
41,301,987 Total Patients Enrolled
Mayo ClinicLead Sponsor
2,864 Previous Clinical Trials
3,696,465 Total Patients Enrolled
Hani M BabikerPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
BRAF-mutation melanoma tumor status will be established prior to entry based on previous BRAF-gene analysis reports from a Clinical Laboratory Improvement Act (CLIA) qualified laboratory.
You have BRAF V600-mutated melanoma.
You have metastatic melanoma and systemic disease of melanoma.
You have received prior therapy for metastatic disease.
You have received prior BRAF/MEK inhibitor therapy and are aged 18 years or older.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.