Overview

This trial is active, not recruiting.

Conditions unresectable stage iii, stage iv melanoma
Treatments e7080
Phase phase 2
Target VEGF
Sponsor Eisai Inc.
Start date June 2010
End date April 2014
Trial size 182 participants
Trial identifier NCT01136967, E7080-G000-206

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. This study is currently recruiting participants only for Cohort 2. Enrollment is closed for cohort 1.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
e7080
Given orally and once daily to subjects with negative BRAF-V600E mutation (other uncommon BRAF activation mutations are allowed) and not treated with BRAF targeted therapy.
(Experimental)
e7080
Given orally and once daily to subjects with positive BRAF-V600E mutation (additional other uncommon activating BRAF mutations are allowed) and treated with BRAF-V600E targeted therapy

Primary Outcomes

Measure
Objective Response Rate
time frame: First dose -first documentation of disease progression or death measured every 8 weeks

Secondary Outcomes

Measure
Disease Control Rate
time frame: First Dose to disease progression or death followed every 8 weeks
Progression Free Survival
time frame: First Dose to disease progression or death followed every 8 weeks
Safety and tolerability
time frame: : First Dose to disease progression or death followed every 8 weeks
Pharmacokinetics and pharmacodynamics
time frame: First Dose to disease progression or death followed every 8 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Histologically confirmed diagnosis of melanoma. 2. Unresectable Stage III or stage IV melanoma. 3. Evidence of disease progression according to RECIST 1.1 on prior regimen. 4. Subjects with brain metastases will be eligible if they have undergone complete surgical excision and are more then 1 month post surgery with no radiographic evidence of disease recurrence in the brain or have undergone stereotactic radio surgery (gamma knife procedure) and are more then 1 month post procedure and with no radiographic evidence of disease progression in the brain; and are asymptomatic, and discontinued corticosteroid treatment at least 30 days prior starting treatment. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Adequately controlled blood pressure 7. Adequate renal function 8. Adequate bone marrow function 9. Adequate blood coagulation function 10. Adequate liver function 11. Males or females greater than or equal to 18 years of age at the time of informed consent. 12. Negative serum or urine pregnancy test 13. Voluntary agreement to provide written informed consent Exclusion Criteria: 1. Melanoma of intraocular origin 2. Leptomeningeal metastases or brain metastases except as for subjects with brain metastases will be eligible if they have undergone complete surgical excision and are more then 1 month post surgery with no radiographic evidence of disease recurrence in the brain or have undergone stereotactic radio surgery (gamma knife procedure) and are more then 1 month post procedure and with no radiographic evidence of disease progression in the brain; and are asymptomatic, and discontinued corticosteroid treatment at least 30 days prior starting treatment 3. More than 2 prior systemic anticancer regimen treatments including immunotherapies for unresectable stage III or stage IV disease (if BRAF V600E mutation negative) or not previously treated with BRAF V600E-targeted therapy or received in the past more than two prior systemic anticancer regimen treatments, including immunotherapies, in addition to a BRAF-V600E-targeted therapy (if BRAF V600E mutation positive) 4. Any anti-cancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug 5. Inability to take oral medication, gastrointestinal malabsorption, or any other condition that might affect the absorption of E7080. 6. Major surgery within 3 weeks prior to the first dose of study drug. 7. Significant cardiovascular impairment 8. Bleeding disorder or a thrombotic disorder requiring anticoagulant therapy 9. Active malignancy (except for melanoma, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24 months. 10. Females who are pregnant or breastfeeding. 11. Known intolerance to the study drug (or any of the excipients). 12. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial. 13. prolongation of QTc interval greater than 480 msec 14.24 hour urine protein greater than or equal 1 gm 15.Active hemoptysis within 3 wks prior to the first dose of study drug.

Additional Information

Official title An Open-Label, 2-Cohort, Multicenter, Phase 2 Study of E7080 in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma
Description This is a multicenter, open-label, 2-cohort, 2 - stage, 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 up to two prior systemic anticancer regimen treatments for unresectable stage III or stage IV melanoma, Cohort 2 will enroll subjects harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF-V600E-targeted therapy. Eligible subjects must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Eisai Inc..