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A Phase II (BRF113710) Single-arm, Open-label Study of GSK2118436 in BRAF Mutant Metastatic Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

A Phase II (BRF113710) Single-arm, Open-label Study of GSK2118436 in BRAF Mutant Metastatic Melanoma


Inclusion Criteria:



- Must be at least 18 years of age

- Must have histologically confirmed cutaneous metastatic melanoma (Stage IV) that is
BRAF mutation-positive (V600 E/K) as determined via central testing with a BRAF
mutation assay.

- Is treatment naive or has received prior treatment for metastatic melanoma.

- Must have measurable disease according to Response Evaluation Criteria in Solid
Tumors (RECIST 1.1).

- Women of child-bearing potential must have a negative pregnancy test within 14 days
prior to the first dose of study treatment.

- Women with reproductive potential must be willing to practice acceptable methods of
birth control during the study and for up to 4 weeks after the last dose of study
medication.

- Men with reproductive potential must be willing to practice acceptable methods of
birth control during the study and for up to 16 weeks after the last dose of study
medication.

- Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

- Adequate organ function.

Exclusion Criteria:

- Previous treatment with a BRAF or MEK inhibitor.

- Cancer therapy (chemotherapy with delayed toxicity, radiation therapy, immunotherapy,
biologic therapy, or major surgery) within the last 3 weeks; chemotherapy regimens
without delayed toxicity within the last 2 weeks; or use of any investigational
anti-cancer or other drug within 28 days or 5 half-lives, whichever is longer,
preceding the first dose of GSK2118436.

- A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or
Hepatitis C Virus (HCV) infection.

- History or evidence of brain metastases on MRI or head CT if MRI is not able to be
performed.

- History of other malignancy. Subjects who have been disease-free for 5 years, or
subjects with a history of completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma are eligible.

- Certain cardiac abnormalities.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate in V600E mutant melanoma subjects, which is defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR) by investigator assessment as per RECIST 1.1 criteria.

Outcome Time Frame:

Approximately 2 years

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Italy: Agenzia Italiana del Farmaco

Study ID:

113710

NCT ID:

NCT01153763

Start Date:

August 2010

Completion Date:

August 2012

Related Keywords:

  • Melanoma
  • Metastatic melanoma
  • BRAF mutant
  • Melanoma
  • BRAF mutant metastatic melanoma
  • Melanoma

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SitePittsburgh, Pennsylvania  15213