Study of Trametinib and Nab-paclitaxel in Patients With Melanoma

Part of paid clinical trials in Denver, Colorado.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT02300935
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study will investigate the combination of two drugs, trametinib and nab-paclitaxel, in patients with advanced unresectable or metastatic melanoma. Each drug has shown activity in trials of patients with melanoma. However, the combination of these two drugs has not been studied. In this trial the investigators will determine the maximum dose of the drug combination to be administered to patients with advanced unresectable or metastatic melanoma and examine the safety profile of the drug combination.

Key Dates

Start date
Dec 31, 2015
Status verified
May 2019
Primary completion
Jan 20, 2016
Completion
Jan 20, 2016

Study Design

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

Arms

  • Experimental: trametinib and nab-paclitaxel
    Trametinib will be dosed at 1mg, 1.5mg, and 2mg orally (PO) daily based on Phase I data of this drug as a single agent. All patients entering this study will receive intravenous (IV) nab-paclitaxel on Day 1, 8, and 15. Dose levels will be assigned to each patient, and dose escalation decisions will be based on the evaluation of safety data from the prior cohort.

Primary Outcome Measure

Number of patients with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: weekly for the first 4 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Colorado Blood Cancer InstituteDenverColorado80218-
Florida Cancer CenterSarasotaFlorida34232-
Tennessee Oncology PLLCNashvilleTennessee37203-

Find similar trials in Denver, CO

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Colorado Blood Cancer Institute· Denver, COFlorida Cancer Center· Sarasota, FLTennessee Oncology PLLC· Nashville, TN

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