A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Dabrafenib

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.