An Open-Label, 2-Cohort, Multicenter, Study of E7080 in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma
Summary
The purpose of this study is to assess the objective response rate of E7080 in previously treated subjects with American Joint Committee on Cancer (AJCC) unresectable stage III or stage IV melanoma and disease progression.
Description
This is a multicenter, open-label, 2-cohort, phase 2 study to assess the objective response rate of E7080 in previously treated subjects with American Joint Committee on Cancer (AJCC) unresectable stage III or stage IV melanoma and disease progression. Cohort 1 will enroll subjects not harboring the V600E BRAF mutation with disease progression following first-line standard of care therapy, and Cohort 2 will enroll subjects harboring the V600E BRAF mutation with disease progression following BRAF-V600E-targeted therapy. Eligible subjects must have measurable disease according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Unresectable Stage III or Stage IV Melanoma
Intervention
E7080, E7080
Location
Brimingham
Alabama
United States
Status
Recruiting
Source
Eisai Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01136967
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:13:10-0400
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Medical and Biotech [MESH] Definitions
Pachytene Stage
The stage in the first meiotic prophase, following ZYGOTENE STAGE, when CROSSING OVER between homologous CHROMOSOMES begins.
Odontogenesis
The process of TOOTH formation. It is divided into several stages including: the dental lamina stage, the bud stage, the cap stage, and the bell stage. Odontogenesis includes the production of tooth enamel (AMELOGENESIS), dentin (DENTINOGENESIS), and dental cementum (CEMENTOGENESIS).
Mart-1 Antigen
A melanosome-specific protein that plays a role in the expression, stability, trafficking, and processing of GP100 MELANOMA ANTIGEN, which is critical to the formation of Stage II MELANOSOMES. The protein is used as an antigen marker for MELANOMA cells.
Cleavage Stage, Ovum
The earliest developmental stage of a fertilized ovum (ZYGOTE) during which there are several mitotic divisions within the ZONA PELLUCIDA. Each cleavage or segmentation yields two BLASTOMERES of about half size of the parent cell. This cleavage stage generally covers the period up to 16-cell MORULA.
Complement Fixation Tests
Serologic tests based on inactivation of complement by the antigen-antibody complex (stage 1). Binding of free complement can be visualized by addition of a second antigen-antibody system such as red cells and appropriate red cell antibody (hemolysin) requiring complement for its completion (stage 2). Failure of the red cells to lyse indicates that a specific antigen-antibody reaction has taken place in stage 1. If red cells lyse, free complement is present indicating no antigen-antibody reaction occurred in stage 1.
