Dose-Finding of Retinoid 9cUAB30 in Healthy Volunteers

NCT01336387 | Terminated Phase 1

• 3 other identifiers: NCI-2013-00468CO10311N01CN35153
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy, no Evidence of Disease

Outcome Measures

Primary Outcomes (2)

• Recommended phase II dose of 9cUAB30 based on the MTD

  28 days

• Pharmacokinetics of 9cUAB30 in normal volunteers

  Using one-sample t-tests, or Wilcoxon signed-rank tests as appropriate in order to evaluate the single vs. steady state levels. An appropriate regression model will be used to explore the relationship of dose with change in PK.

  Baseline, days 1, 8, 15, 22, 36, and 43

Secondary Outcomes (2)

• Correlation between pharmacokinetic and toxicity as assessed by CTCAE

  Up to 36 days

• Comparison of toxicity between placebo and controls as assessed by CTCAE

  Up to 36 days

Study Arms (2)

Arm I (retinoid 9cUAB30)

EXPERIMENTAL

Participants receive retinoid 9cUAB30\* PO on days 1-28.

Drug: retinoid 9cUAB30; Other: pharmacological study; Other: laboratory biomarker analysis; Other: cancer prevention

Arm II (placebo)

PLACEBO COMPARATOR

Participants receive placebo\* PO on days 1-28.

Other: placebo; Other: pharmacological study; Other: laboratory biomarker analysis; Other: cancer prevention

Interventions

retinoid 9cUAB30 DRUG

Given PO

Arm I (retinoid 9cUAB30)

placebo OTHER

Given PO

Also known as: PLCB

Arm II (placebo)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

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

laboratory biomarker analysis OTHER

Correlative studies

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

cancer prevention OTHER

Disease prevention

Also known as: cancer prevention intervention

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

Eligibility Criteria

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

You may qualify if:

• ECOG performance status =\< 1 (Karnofsky \>= 70%)
• WBC \>= 3000/mm\^3
• Platelets \>= 100,000mm\^3
• Bilirubin =\< upper limit of institutional normal
• AST =\< upper limit of institutional normal
• Creatinine within institutional normal limits
• Sodium =\< upper limit of institutional normal
• Potassium =\< upper limit of institutional normal
• Chloride =\< upper limit of institutional normal
• Bicarbonate =\< upper limit of institutional normal
• Fasting triglycerides =\<1.5 x 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
• The effects of 9cUAB30 on the developing human fetus are unknown; for this reason, women 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
• 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; detailed list of potentially interacting medications
• Participants may not be taking lipid lowering agents
• Participants may not be receiving any other investigational agents
• 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
• Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 9cUAB30, 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 HIV-positive may not participate in this study; the uncertain immune status of HIV-positive people and the potential risks of taking part in this study are too great to justify this non-treatment therapy
• 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; the effects of this study agent on the immune system of people at risk for recurring cancer are unknown

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

UAB 30

Study Officials

• Jill Kolesar

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: April 15, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 9, 2014

Record last verified: 2013-05

Locations

US (1)