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An Open-Label, 2-Cohort, Multicenter, Phase 2 Study of E7080 in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Unresectable Stage III or Stage IV Melanoma

Thank you

Trial Information

An Open-Label, 2-Cohort, Multicenter, Phase 2 Study of E7080 in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma


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)


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 > 480 msec

14. 24 hour urine protein >/= 1 gm

15. Active hemoptysis within 3 wks prior to the first dose of study drug.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Time Frame:

First dose -first documentation of disease progression or death measured every 8 weeks

Safety Issue:

No

Principal Investigator

Eisai US Medical Services

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Limited

Authority:

United States: Food and Drug Administration

Study ID:

E7080-G000-206

NCT ID:

NCT01136967

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Unresectable Stage III or Stage IV Melanoma
  • Melanoma

Name

Location

Alexandria, Minnesota  56308
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Louisville, Kentucky  40207
McLean, Virginia  22101
Hackensack, New Jersey  07601
Denver, Colorado  
Boston, Massachusetts  
Eugene, Oregon  
Milwaukee, Wisconsin  
Lebanon, New Hampshire  
Las Vegas, Nevada  89109
Jackson, Mississippi