A Biomarker Evaluation Trial of UAB30 in Renal Transplant Recipients at High Risk for Non-melanoma Skin Cancer
Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, placebo-controlled biomarker study in renal transplant
recipients with actinic damage and a history of basal cell carcinomas and/or cutaneous
squamous cell carcinomas. There will be two arms to the study: 1) daily oral UAB30 for 28
days; and 2) daily oral placebo for 28 days. The total duration of the study is anticipated
to be 5 years. The hypothesis being tested is that a significantly greater percentage of
subjects randomized to oral UAB30 over a period of 28 days will achieve ≥30% reduction in
biomarkers of proliferation and ≥30% increase in apoptosis biomarkers than those who receive
placebo. Cyclin D1 will serve as the primary biomarker.
This investigation will determine whether subjects randomized to UAB30 have an increase in
all trans-retinoic acid responsive genes in the skin compared to those receiving placebo.
This will include an examination of target effects of UAB30 by evaluating its effects in vivo
in humans on the DNA damage response and Src signaling pathways.