Spots Global Cancer Trial Database for Evaluation of Pathway Modulation by Raf, MEK, & Kinase Inhibitors

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Trial Identification

Brief Title: Evaluation of Pathway Modulation by Raf, MEK, & Kinase Inhibitors

Official Title: Pilot Study to Evaluate the Signaling Pathway Modulation Demonstrated by Raf, MEK, and Kinase Inhibitors In Human Skin With or Without Solar Simulated Light

Study ID: NCT03176485

Conditions

Metastatic Cancer

Melanoma

Colon Cancer

Differentiated Thyroid Cancer

Hepatocellular Carcinoma

Renal Cell Carcinoma

Metastatic Melanoma

HCC

Metastatic Colon Cancer

Interventions

Solar Simulator

Study Description

Brief Summary: This is a pilot study designed to evaluate the cutaneous effect of systemic inhibition of the tyrosine kinase pathway in the presence or absence of solar simulated light exposure. A maximum of 45 subjects will be accrued into the overall study we anticipate approximately 25 patients in the Raf inhibitor group and 10 patients each into the Tyrosine Kinase and MEK inhibitor arms of the study.

Detailed Description: The study will evaluate the modulatory effect of systemic Raf inhibition in the MEK/ERK and PI3 /Akt/mTOR pathways in patients undergoing targeted therapy for metastatic disease. Changes in relevant proteins will be evaluated using a combined protein expression methodology that in includes immunohistochemistry (IHC) and reverse phase protein microarray (RPPA) technology. The primary endpoint of this study will be assessed in normal skin and skin acutely exposed to solar simulated light