A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma

Completed · Phase 3

Conditions studied: Cancer

In brief

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 metastatic (Stage IV) melanoma. Subjects will be randomized to receive 150 mg of GSK2118436 twice daily or 1000 mg/m2 DTIC every 3 weeks and continue on treatment until disease progression, death, or unacceptable adverse event. Subjects who progress on DTIC will be allowed to crossover to an optional extension arm of the study to receive GSK2118436.

Key facts

Study ID

NCT01227889

Run by

GlaxoSmithKline

People needed

251

Starts

2010-12-23

Expected to finish

2016-09-16

Last updated by the study team

2017-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — La Jolla, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Vallejo, California, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Ann Arbor, Michigan, United States
• GSK Investigational Site — Lebanon, New Hampshire, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Westmead, New South Wales, Australia
• GSK Investigational Site — Southport, Queensland, Australia
• GSK Investigational Site — Adelaide, South Australia, Australia
• GSK Investigational Site — Nedlands, Western Australia, Australia
• GSK Investigational Site — Edmonton, Alberta, Canada
• GSK Investigational Site — Kelowna, British Columbia, Canada
• GSK Investigational Site — Toronto, Ontario, Canada
• GSK Investigational Site — Toronto, Ontario, Canada
• GSK Investigational Site — Montreal, Quebec, Canada
• GSK Investigational Site — Bordeaux, France
• GSK Investigational Site — Lille, France
• GSK Investigational Site — Marseille, France
• GSK Investigational Site — Nice, France
• GSK Investigational Site — Paris, France
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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