Dose-Finding of Retinoid 9cUAB30 in Healthy Volunteers

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Healthy, no Evidence of Disease

In brief

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.

Key facts

Study ID

NCT01336387

Run by

National Cancer Institute (NCI)

People needed

50

Starts

2011-10-01

Expected to finish

2012-09-01

Last updated by the study team

2014-10-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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:
• Female with bilateral oophorectomy and/or hysterectomy
• Female with fallopian tubes cut, tied, or sealed
• Female with sterilization implant (e.g. Adiana, Essure) placed > 3 months prior to randomization
• Female post-menopausal (> 1 year since last menses)
• Male with vasectomy > 3 months prior to randomization
• One of the following methods of birth control must be used by women of childbearing potential:
• Combined oral contraceptive pill in continuous use for > 30 days prior to study entry
• Vaginal ring (e.g. NuvaRing) in continuous use for > 30 days prior to study entry
• Skin patch (e.g. Ortho Evra) in continuous use for > 30 days prior to study entry
• Injection (e.g. Depo-Provera, Noristerat®) in continuous use for > 30 days prior to study entry

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

Where it is running

• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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