A Study of the Effect of Sorafenib or Regorafenib on p63 Expression and Keratinocyte Differentiation in Human Skin
Skin toxicity is a frequently observed side effect in the era of "molecularly targeted
therapies". Skin toxicity following administration of protein kinase inhibitors such as
sorafenib, regorafenib, lapatinib, sunitinib, and others can be debilitating to the patient,
resulting in dose reduction and discontinuation of treatment. The mechanisms of skin
toxicity induced by targeted chemotherapy, such as sorafenib or regorafenib, are poorly
understood. Further research is warranted to better understand the pathophysiology of
drug-related skin toxicity in this setting and develop correction strategies. This study
tests the hypothesis that sorafenib and regorafenib interfere with p63 expression and
keratinocyte differentiation and skin remodeling.
Eligible study participants will be evaluated clinically for evidence of skin toxicity
during their visits to the outpatient Oncology clinics. Study participants will undergo
skin biopsies before sorafenib or regorafenib treatment is initiated and once rash develops
or 12 weeks into treatment with sorafenib or regorafenib. Skin biopsies will be performed
in Oncology clinics by the study investigators and clinic support staff.
Study participants will undergo both skin biopsies regardless of whether they develop a
rash. In patients who develop a rash the most representative lesion will be biopsied. A
normal appearing area of skin will be biopsied in participants who do not develop a rash.
White River Junction, VT
View more details from ClinicalTrials.gov.
For more information about a clinical trial, clinical trial eligibility, or informed consent, contact our research nurses by phone or email:
Please Note: Any eligibility criteria noted are subject to change. Our research nurses can provide you with the most current eligibility and exclusion criteria. Any study involvement to be undertaken must ultimately be determined on an individual basis.