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Sorafenib

Skin biopsy prior to sorafenib or regorafenib treatment and when rash appears or 12 weeks into treatment.

skin punch biopsy

Alexey V Danilov, MD

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.

skin biopsies will be performed using a 4mm biopsy punch. Participants will undero 2 skin biopsies - one prior to starting sorafenib or regorafenib, the other once rash develops. If a rash does not develop within 84 days a biopsy of normal skin will be done.

Effect of Sorafenib or Regorafenib on P63 Expression and Keratinocyte Differentiation in Human Skin

A Study of the Effect of Sorafenib or Regorafenib on p63 Expression and Keratinocyte Differentiation in Human Skin

Tissue collection is done within 7 days prior to treatment and when rash develops. If no rash develops, normal skin will be biopsied at week twelve of treatment.

Sorafenib and regorafenib potentially interfere with p63 expression and keratinocyte differentiation and skin remodeling. The extent of interference may indicate extent of tumor response.

Dartmouth-Hitchcock Medical Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Sorafenib or Regorafenib on P63 Expression and Keratinocyte Differentiation in Human Skin	NCT01466504	Renal Cell Carc... Hepatocellular ... Colorectal Carc...	skin punch biop...	18 Years -	Dartmouth-Hitchcock Medical Center
Effect of Sorafenib or Regorafenib on P63 Expression and Keratinocyte Differentiation in Human Skin	NCT01466504	Renal Cell Carc... Hepatocellular ... Colorectal Carc...	skin punch biop...	18 Years -	Dartmouth-Hitchcock Medical Center
Effect of Sorafenib or Regorafenib on P63 Expression and Keratinocyte Differentiation in Human Skin	NCT01466504	Renal Cell Carc... Hepatocellular ... Colorectal Carc...	skin punch biop...	18 Years -	Dartmouth-Hitchcock Medical Center
Effect of Sorafenib or Regorafenib on P63 Expression and Keratinocyte Differentiation in Human Skin	NCT01466504	Renal Cell Carc... Hepatocellular ... Colorectal Carc...	skin punch biop...	18 Years -	Dartmouth-Hitchcock Medical Center

Spots Global Cancer Trial Database for p63

Every month we try and update this database with for p63 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for p63

Every month we try and update this database with for p63 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for p63 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.