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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT02296112
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Melanoma
  • Stage IIIB Melanoma
  • Stage IIIC Melanoma
  • Stage IV Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • trametinib — DRUG
    Given PO
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies

Study Details

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.

Key Dates

Start date
Jan 31, 2015
Status verified
May 2021
Primary completion
Aug 31, 2018
Completion
Apr 16, 2021

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (trametinib)
    Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Response Rate in "High Affinity" Group [ Time Frame: Up to 12 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Washington D.C., DC

By research site
Georgetown University Medical Center· Washington D.C., DCDana-Farber Cancer Institute· Boston, MAVanderbilt-Ingram Cancer Center· Nashville, TNM D Anderson Cancer Center· Houston, TX

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