Clinical Trials Directory

Trials / Completed

CompletedNCT02296112

Trametinib in Treating Patients With Advanced Melanoma With BRAF Non-V600 Mutations

A Phase II Open-Label, Two-Arm Study of the MEK Inhibitor, Trametinib, to Investigate the Safety and Anti-Cancer Activity in Subjects With Melanoma With BRAF Non-V600 Mutations

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
9 (actual)
Sponsor
Vanderbilt-Ingram Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies trametinib in treating patients with melanoma with v-Raf murine sarcoma viral oncogene homolog B (BRAF) non-V600 mutations that has spread to other places in the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the clinical efficacy of trametinib in advanced BRAF nonV600mutation (MUT) melanoma ("high activity" group). SECONDARY OBJECTIVES: I. To characterize the safety of trametinib. II. To evaluate the progression-free survival (PFS) and overall survival (OS) of trametinib in advanced BRAF nonV600MUT melanoma. TERTIARY OBJECTIVES: I. To determine the clinical efficacy of trametinib in advanced BRAF nonV600MUT melanoma ("low activity/unknown" group). II. Identify mechanisms of resistance to trametinib in this patient population. OUTLINE: Patients receive trametinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 28 days.

Conditions

Interventions

TypeNameDescription
DRUGtrametinibGiven PO
OTHERlaboratory biomarker analysisCorrelative studies
OTHERpharmacological studyCorrelative studies

Timeline

Start date
2015-01-01
Primary completion
2018-08-01
Completion
2021-04-16
First posted
2014-11-20
Last updated
2021-05-28
Results posted
2019-08-08

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02296112. Inclusion in this directory is not an endorsement.