CLINICAL TRIAL SUMMARY

MDACC Study No:2009-0949 (clinicaltrials.gov NCT No: NCT01072175)
Title:An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the BRAF Inhibitor GSK2118436 in Combination with the MEK Inhibitor GSK1120212 in Subjects with BRAF Mutant Metastatic Melanoma
Principal Investigator:Kevin B. Kim
Treatment Agent:GSK1120212; GSK2118436
Study Status:Closed
Study Description:The goal of this clinical research study is to find the best dose of the drugs
dabrafenib and trametinib that can be given together or alone in patients with
advanced solid cancer that has a BRAF mutation. The effects of the study drugs
at different dose levels and the safety of the study drugs will also be
studied.

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Disease Group:Melanoma; Phase I Studies; Solid Tumors
Phase of Study:Phase I/Phase II
Treatment Agents:GSK1120212
GSK2118436
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:This protocol will be performed on an outpatient basis.
Supported By:GlaxoSmithKline
Return Visit:Part A: screening, Day 1, Day 15, Day 16, week 4, week 6, week 8, every 4
weeks, follow up
Part B: screening, Day 1, Day 8, Day 15, Day 21, every 4 weeks
Part C: screening, Day 1, Day 15, 6 weeks, every 4 weeks
Home Care:Study drug may be taken at home.


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Physician Name:Kevin B. Kim
Dept:Anatomic Pathology
For Clinical Trial Enrollment:713-792-2921
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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