Overview

This trial is active, not recruiting.

Condition melanoma
Treatment gsk2118436
Phase phase 2
Target BRAF
Sponsor GlaxoSmithKline
Start date August 2010
End date July 2011
Trial size 92 participants
Trial identifier NCT01153763, 113710

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.
gsk2118436
Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.

Primary Outcomes

Measure
Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator for Participants Who Had a BRAF V600E Mutation
time frame: From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to 26.9 weeks)

Secondary Outcomes

Measure
Number of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation
time frame: From the first dose of study medication until the first documented evidence of a confirmed complete response or partial response (up to 11 weeks)
Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation
time frame: From the first dose of study medication to the earliest date of disease progression or death due to any cause (up to 9.9 months)
Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation
time frame: From the first dose of study medication to the earliest date of disease progression or death due to any cause (up to 9.9 months)
Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation
time frame: From the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 31.3 weeks)
Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation
time frame: From the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 29.6 weeks)
Overall Survival for Participants Who Had a BRAF V600E Mutation
time frame: From the first dose of study medication to death due to any cause (up to 9.9 months)
Overall Survival for Participants Who Had a BRAF V600K Mutation
time frame: From the first dose to death due to any cause (up to 9.9 months)

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Phase II (BRF113710) Single-arm, Open-label Study of GSK2118436 in BRAF Mutant Metastatic Melanoma
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.