Retinoid 9cUAB30 in Preventing Cancer in Healthy Volunteers

NCT01935960 | Completed Phase 1 DMC

• 5 other identifiers: NCI-2013-01655UW13022UWI10-16-01RN01CN35153P30CA014520
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (2)

• Recommended phase II dose of retinoid 9cUAB30, based on maximum tolerated dose (MTD), defined as the highest dose level with < 25% of treated patients experiencing a grade 2 toxicity or any treated patients experiencing a grade 3 or higher toxicity

  Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

  Up to 30 days after completion of study treatment

• Urine & plasma single dose & steady state PK of retinoid 9cUAB30, including maximum concentration (Cmax), time to peak concentration (Tmax), area under curve (AUC)0-least quantifiable concentration (lqc), AUC0-infinity, half-life (T½), and clearance (CL)

  Basic pharmacokinetic and summary pharmacokinetic measures from the extensive plasma sampling on days 1 and 36, and levels obtained from single plasma and urine samples taken on days 8, 15, 22, and 29 will be summarized with basic statistics, including means, standard errors, medians, and interquartile ranges by dose, visit, and time point, as available.

  Baseline; 30, 45, 60, and 90 minutes; 2, 4, 6, 8, 12, 16, 20, and 24 hours on day 1; and 8, 15, 22, 29, 36, and 43 days

Secondary Outcomes (2)

• Change in single dose pharmacokinetics, including Cmax, Tmax, AUC0-lqc, AUC0-infinity, T1/2, and CL

  Day 1 to day 36

• Incidence of toxicity, graded according to the CTCAE version 4.0

  Up to 30 days after completion of study treatment

Study Arms (2)

Arm I (retinoid 9cUAB30)

EXPERIMENTAL

Participants receive retinoid 9cUAB30 PO QD on days 1 and 8-36. Treatment continues in the absence of unacceptable toxicity.

Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Retinoid 9cUAB30

Arm II (placebo)

PLACEBO COMPARATOR

Participants receive a placebo PO QD on days 1 and 8-36.

Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Other: Placebo

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (retinoid 9cUAB30); Arm II (placebo)

Pharmacological Study OTHER

Correlative studies

Arm I (retinoid 9cUAB30); Arm II (placebo)

Placebo OTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Arm II (placebo)

Retinoid 9cUAB30 DRUG

Given PO

Also known as: 9cUAB30

Arm I (retinoid 9cUAB30)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal volunteers, either male or female
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 or Karnofsky \>= 70%
• White blood cell (WBC) \>= 3000/mm\^3
• Platelets \>= 100,000/mm\^3
• Hemoglobin \> 10 g/dL
• Bilirubin =\< upper limit of institutional normal
• Aspartate aminotransferase (AST) =\< upper limit of institutional normal
• Creatinine within institutional normal limits
• Sodium, potassium, chloride, bicarbonate: all =\< upper limit of institutional normal
• Fasting triglycerides =\< 1.5 x upper limit of normal (ULN)
• Fasting cholesterol =\< 1.5 x ULN
• Participants must agree to discontinue all vitamin supplements while taking study medication and for thirty days past the last dose of study medication
• Heterosexual women and men must agree to use TWO effective forms of birth control for the duration of study participation and for 30 days following the last dose of study medication
• Men must agree not to donate sperm during the study and for three months after receiving the last dose of study drug
• The following persons are not considered to be able to father or bear children and therefore are eligible to participate without the use of concurrent birth control:

You may not qualify if:

• Participants may not be taking medications that might interact with 9cUAB30
• Participants may not be taking lipid lowering agents
• Participants may not receive any other investigational agents within 30 days of enrollment nor during study participation
• Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition of retinoids
• Participants with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Breastfeeding must be discontinued for the duration of study participation and for one month after the last dose of the study agent if the mother is treated with 9cUAB30
• Individuals known to be human immunodeficiency virus (HIV)-positive may not participate in this study
• Individuals with a history of cancer diagnosis or reoccurrence \< 5 years from study entry may not participate; however, individuals with a history of squamous or basal cell carcinoma of the skin \< 5 years from study entry will not be excluded from this study

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

UAB 30

Study Officials

• Jill Kolesar

  University of Wisconsin Chemoprevention Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 5, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2016
• Last Updated: December 23, 2016

Record last verified: 2016-12

Locations

US (3)