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

18 Years
Not Enrolling
Renal Cell Carcinoma, Hepatocellular Carcinoma, Colorectal Carcinoma

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Trial Information

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

Inclusion Criteria:

1. Male or female, 18 years old or older.

2. Histologically or cytologically confirmed diagnosis of a solid tumor (RCC, HCC, or
colorectal cancer).

3. Participants are planning to initiate treatment with either sorafenib or regorafenib
as a single chemotherapeutic agent

4. Able to swallow and retain oral medication and does not have any clinically relevant,
active gastrointestinal disease or other condition that may significantly alter
absorption, distribution, metabolism, or excretion of drugs.

5. Be able to provide written informed consent.

Exclusion Criteria

1. Patients who are or will be receiving other chemotherapeutic or molecularly targeted
agents in addition to sorafenib or regorafenib

2. Concurrent moderate or severe chronic inflammatory skin condition (eczema, psoriasis)

3. Concurrent blistering skin disorder of any severity (such as pemphigus, bullous

4. Connective tissue disorders with skin involvement (systemic lupus erythematosus,
scleroderma, dermatomyositis, etc.)

5. Patients manifesting an allergic skin reaction (such as urticaria) or skin reaction
as a complication of prior chemotherapy

6. Patients with skin lesions of infectious or non-infectious cause, precluding skin

7. Patients not willing to undergo skin biopsy

8. Patients who are pregnant or planning to become pregnant during their participation
in the study.

9. Chemotherapy, targeted therapy, or biological therapy within two weeks of start of

10. Ability to give informed consent is compromised by cognitive and/or decisional

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

p63 expression levels

Outcome Description:

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.

Outcome Time Frame:

Week 12

Safety Issue:


Principal Investigator

Alexey V Danilov, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2011

Completion Date:

April 2013

Related Keywords:

  • Renal Cell Carcinoma
  • Hepatocellular Carcinoma
  • Colorectal Carcinoma
  • P63
  • Sorafenib
  • Regorafenib
  • rash
  • skin toxicity
  • RCC
  • HCC
  • colorectal carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell
  • Colorectal Neoplasms
  • Carcinoma, Hepatocellular



Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center Lebanon, New Hampshire  03756
White River Junction VA Medical Center White River Junction, Vermont  05009