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.
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)
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Unresectable Stage III or Stage IV Melanoma
E7080, E7080
Brimingham
Alabama
United States
Recruiting
Eisai Inc.
Published on BioPortfolio: 2014-08-27T03:13:10-0400
An Open Label Phase I Dose Escalation Study Of E7080
The purpose of this study is to determine the maximum tolerated dose (MTD) of E7080 in patients with solid tumors or lymphomas.
This is an open-label, multicenter, Phase 1b/2 study of E7080 alone and in combination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma following o...
The purpose of this study is to determine the safety and efficacy of oral E7080 in medullary and iodine-131 refractory, unresectable differentiated thyroid cancers.
Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC)
The purpose of this study is to determine maximum tolerated dose (MTD), efficacy, safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 when is admini...
The purpose of this study is to determined the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered contin...
Treatment for patients with V600 mutation of the B-Raf protooncogene BRAF (BRAF-V600) and metastatic stage IV or unresectable stage III melanoma has greatly advanced with the introduction of selective...
Neovascular age-related macular degeneration (AMD) is a leading cause of vision loss worldwide. Although intravitreal injection of anti-VEGF antibodies and VEGF Trap have significant clinical benefits...
A systematic review and meta-analysis of utility estimates in melanoma.
We sought to determine pooled estimates of utility-based health-related quality-of-life (HRQOL) (utilities) for people with American Joint Cancer Committee stage I/II, III, IV melanoma for use in econ...
Phase II study of ipilimumab in adolescents with unresectable stage III or IV malignant melanoma.
Ipilimumab is approved for the treatment of advanced melanoma in adults; however, little information on the efficacy and safety of ipilimumab in younger patients is available.
Hypertension (HTN) is an established class effect of vascular endothelial growth factor receptor (VEGFR) inhibition. In the phase 3 Study of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid ...
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.