Trials / Completed
CompletedNCT03176485
Evaluation of Pathway Modulation by Raf, MEK, & Kinase Inhibitors
Pilot Study to Evaluate the Signaling Pathway Modulation Demonstrated by Raf, MEK, and Kinase Inhibitors In Human Skin With or Without Solar Simulated Light
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- University of Arizona · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Metastatic Cancer
- Melanoma
- Colon Cancer
- Differentiated Thyroid Cancer
- Hepatocellular Carcinoma
- Renal Cell Carcinoma
- Metastatic Melanoma
- HCC
- Metastatic Colon Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Solar Simulator | A Multiport UV Solar Simulator Model 600 (Solar Light Co., Inc., Philadelphia, PA) will be used to administer Solar Simulated Light (SSL) exposures to formerly unexposed buttock skin.The device is equipped with six 8mm liquid light guides (LLG), allowing for 6 simultaneously conducted exposures.A large 3x2 endplate places the LLGs several centimeters apart and is specifically designed for Sun Protection Factor (SPF) and photo patch testing. The dose of emission from each LLG can be precisely regulated and the spectrum of emission can be limited to UVA (320-390 nm) or UVB+UVA (290-390 nm). The operator can select between UVA only and a combined Ultraviolet-A (UVA)/ Ultraviolet-B (UVB) spectrum by placement of an optical filter. The spectral output (indicated below) follows the distribution of sunlight from 290 to 390 nm. |
Timeline
- Start date
- 2014-10-17
- Primary completion
- 2018-11-01
- Completion
- 2018-11-01
- First posted
- 2017-06-05
- Last updated
- 2019-01-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03176485. Inclusion in this directory is not an endorsement.