A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: GSK2118436
Intervention description: Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.
Intervention MeSH terms: Dabrafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic melanoma; BRAF mutant; Melanoma; BRAF mutant metastatic melanoma

Summary:

      BRF113710 is a Phase II, single-arm, open-label study to assess the efficacy, safety, and
      tolerability of GSK2118436 administered twice daily as a single agent in subjects with BRAF
      mutant metastatic melanoma. Subjects will receive 150 mg of GSK2118436 twice daily and
      continue on treatment until disease progression, death, or unacceptable adverse event.
    

Eligibility criteria:

        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.