NCT01935960

Retinoid 9cUAB30 in Preventing Cancer in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subject

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
OTHER	Placebo	Given PO
DRUG	Retinoid 9cUAB30	Given PO

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-10-01
• First posted: 2013-09-05
• Last updated: 2016-12-23

Locations

3 sites across 1 country: United States