Dose-Finding of Retinoid 9cUAB30 in Healthy Volunteers

Healthy, no Evidence of Disease Clinical Trial

Official title: A Randomized, Double-Blind, Single-dose and Multi-dose Study of the Novel Retinoid, 9cUAB30, to Determine Pharmacokinetics and Safety

Status Terminated

Clinical Trial Summary

This randomized phase I trial studies the side effects and the best dose of retinoid 9cUAB30 in healthy volunteers. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of retinoid 9cUAB30 may keep cancer from forming.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. The primary objective is to determine the toxicities and recommended phase II dose of 9cUAB30. The co- primary objective is 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 PK after repeat dosing (Day 1 vs. Day 36).

IV. To assess the following potential biomarkers of UAB30:

• Telomerase activity (measurement of telomeric repeats) in PBMCs.

• Gene expression of DNA methyltransferase in PBMCs.

• Gene expression of CYP2B6 in PBMCs.

OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 2 treatment arms.

ARM I: Participants receive retinoid 9cUAB30* orally (PO) on days 1-28.

ARM II: Participants receive placebo* PO on days 1-28.

Courses repeat every 28 days in the absence of unacceptable toxicity.

*NOTE: Participants receive doses on days 8, 15, 22 and 29 after they have fasted for 12 hours.

After completion of study treatment, patients are followed up on days 7 and 30. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy, no Evidence of Disease

• NCT number: NCT01336387
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Terminated
• Phase: Phase 1
• Start date: October 2011
• Completion date: September 2012