Spots Global Cancer Trial Database for Retinoid 9cUAB30 in Preventing Cancer in Healthy Volunteers

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Trial Identification

Brief Title: Retinoid 9cUAB30 in Preventing Cancer in Healthy Volunteers

Official Title: A Randomized, Double-Blind, Phase I Dose-Escalation Study of the Novel Retinoid 9cUAB30

Study ID: NCT01935960

Conditions

Healthy Subject

Interventions

Laboratory Biomarker Analysis

Pharmacological Study

Placebo

Retinoid 9cUAB30

Study Description

Brief Summary: This randomized phase I trial studies the side effects and best dose of retinoid 9cUAB30 in preventing cancer in healthy volunteers. The use of retinoid 9cUAB30 may keep cancer from forming in healthy volunteers.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the toxicities and recommended phase II dose of 9cUAB30 (retinoid 9cUAB30). II. To characterize the urine and plasma single dose and steady state pharmacokinetics of 9cUAB30 in normal volunteers. SECONDARY OBJECTIVES: I. To correlate the pharmacokinetics of 9cUAB30 with toxicity. II. To compare observed toxicity between placebo controls and each dose level. III. To assess for any change in single dose pharmacokinetics (PK) after repeat dosing (day 1 vs. day 36). OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 2 treatment arms. ARM I: Participants receive retinoid 9cUAB30 orally (PO) once daily (QD) on days 1 and 8-36. Treatment continues in the absence of unacceptable toxicity. ARM II: Participants receive a placebo PO QD on days 1 and 8-36. After completion of study treatment, patients are followed up at 7 and 30 days.