Status:
COMPLETED
A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
BRF113683 is a Phase III, randomized, open-label study comparing the efficacy, safety, and tolerability of GSK2118436 to dacarbazine (DTIC), in subjects with BRAF mutant advanced (Stage III) or metast...
Eligibility Criteria
Inclusion
- Adults at least 18 years of age
- Has advanced (unresectable Stage III) or metastatic (Stage IV) melanoma that is BRAF mutation positive (V600E)
- Is treatment naive for advanced (unresectable) or metastatic melanoma, with the exception of Interleukin 2 (IL-2) which is allowed.
- Has measurable disease according to RECIST 1.1 criteria.
- 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 adequate organ function.
- Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
Exclusion
- Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy or surgery).
- Evidence of active central nervous system (CNS) disease.
- Previous treatment for metastatic melanoma, including treatment with BRAF or MEK inhibitor.
- A history of other malignancy. Subjects who have been disease-free for 5 years or subjects with a history of complete resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
- History of Human Immunodeficiency Virus (HIV) infection.
- Certain cardiac abnormalities
Key Trial Info
Start Date :
December 23 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2016
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT01227889
Start Date
December 23 2010
End Date
September 16 2016
Last Update
October 4 2017
Active Locations (94)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35243
2
GSK Investigational Site
Mobile, Alabama, United States, 36608
3
GSK Investigational Site
La Jolla, California, United States, 92093
4
GSK Investigational Site
Los Angeles, California, United States, 90095