Status:
COMPLETED
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 9 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01153763
Start Date
August 9 2010
End Date
June 1 2016
Last Update
September 27 2017
Active Locations (23)
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1
GSK Investigational Site
Los Angeles, California, United States, 90025
2
GSK Investigational Site
Los Angeles, California, United States, 90095
3
GSK Investigational Site
San Francisco, California, United States, 94115
4
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104