An Open-Label Phase II Study of the Combination of GSK2118436 and GSK1120212 in Patients With Metastatic Melanoma Which is Refractory or Resistant to BRAF Inhibitor
The goal of this clinical research study is to learn if the combination of 2 drugs dabrafenib and trametinib can help to control melanoma that has or has not spread to the brain. The safety of this drug combination will also be studied.
Dabrafenib is designed to block the mutated BRAF protein. This mutation is only found in moles of the skin and in melanoma cells. By blocking the protein, the drug may slow the growth of or kill cancer cells that have the protein.
Trametinib is designed to block certain proteins that cause cancer cells to grow and multiply. This may cause the cancer cells to die.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Phase II Study of the Combination of GSK2118436 and GSK1120212 in Patients With Metastatic Melanoma Which is Refractory or Resistant to BRAF Inhibitor|
- Overall Response Rate (ORR) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Overall response rate defined as percentage of subjects with a confirmed complete response (CR) or a partial response (PR) at any time as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- Progression-Free Survival (PFS) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Duration of response defined for the subject or subjects with a confirmed complete response (CR) or partial response (PR), as time from the first documented evidence of a CR or PR until the first documented disease progression or death due to any cause. Progression free survival (PFS) estimated and summarized using the method of Kaplan and Meier.
|Study Start Date:||September 2012|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: GSK2118436 + GSK1120212
GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
Starting dose 150 mg by mouth twice a day.Drug: GSK1120212
2 mg by mouth daily.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01619774
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Davies, MD, PHD, BA||M.D. Anderson Cancer Center|