Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Trial of Dabrafenib (BRAFi) and Pazopanib in Patients With BRAF-mutated Advanced Malignant Tumors
This phase I trial studies the side effects and best dose of dabrafenib and pazopanib hydrochloride when given together in treating patients with advanced malignant tumors. Dabrafenib and pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PRIMARY OBJECTIVES:
I. To assess the safety and tolerability of GSK2118436 (dabrafenib) given with pazopanib
(pazopanib hydrochloride) as well as determining the maximum tolerated dosing regimen in
patients with BRAF mutated advanced malignant tumors.
SECONDARY OBJECTIVES:
I. Evaluate pharmacokinetics of the two study drugs and identify potential drug-drug
interactions.
II. Determine pharmacogenomics with microarray testing. III. Perform genotyping of tumors and
if objective tumor response rates are identified.
IV. Assess objective tumor response rates.
OUTLINE: This is a dose-escalation study.
Patients receive dabrafenib orally (PO) twice daily (BID) on days 1-28 (once daily on day 1
and BID on days 3-28 of course 1), and pazopanib hydrochloride PO once daily (QD) on days
1-28 (days 2-28 of course 1). Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
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