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NCT01466504 · ClinicalTrials.gov registry record
Effect of Sorafenib or Regorafenib on P63 Expression and Keratinocyte Differentiation in Human Skin
A clinical trial, sponsored by Dartmouth-Hitchcock Medical Center.
- Terminated
- Registry status
- 4
- Enrollment target
NCT01466504: Clinical Trial study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT01466504 is a clinical trial that was terminated before completion, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01466504 was terminated before completion, sponsored by Dartmouth-Hitchcock Medical Center.
- TERMINATED
- Registry status
- 4 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- PROCEDURE skin punch biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-04 |
Why NCT01466504 stopped before completion
NCT01466504 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 4 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which skin punch biopsy is the first listed.
NCT01466504 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01466504 about?
NCT01466504 is a clinical study titled "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 ...
What is the current status of trial NCT01466504?
This trial is currently terminated. The enrollment target is 4 participants. The study started on 2011-05. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01466504?
The interventions under investigation include: skin punch biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT01466504?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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