A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
Status: | Completed |
---|---|
Conditions: | Skin Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/6/2017 |
Start Date: | December 23, 2010 |
End Date: | September 16, 2016 |
A Phase III Randomized, Open-label Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
12
sites
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