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


Phase 1
18 Years
65 Years
Not Enrolling
Both
Healthy, no Evidence of Disease

Thank you

Trial Information

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


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.


Inclusion Criteria:



- 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

- Copper IUD (e.g. ParaGard)

- Note: because of the decreased effectiveness of low dose progesterone-only
contraceptive methods when used with retinoids, the following hormonal methods
are NOT acceptable:

- Low dose progesterone only oral contraceptive pill ("mini pills" e.g.
Micronor®, Nor-Q.D., Ovrette)

- Norplant subdermal implant

- Mirena® Hormonal Implanted Uterine Device (IUD)

- In addition to the above method of contraception, one of the following methods
of contraception will ALSO be used for the duration of study participation and
for 30 days following the last dose of study medication:

- Diaphragm, cervical cap, or cervical shield with spermicide

- Contraceptive sponge (e.g. Today Sponge)

- Condom (male or female type) plus spermicide

- Females of child-bearing potential must have a negative pregnancy test within the
current menstrual cycle and within 7 days before starting drug

- Participants must have the ability to understand, and the willingness to sign, a
written informed consent document

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Recommended phase II dose of 9cUAB30 based on the MTD

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Jill Kolesar

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin Hospital and Clinics

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2013-00468

NCT ID:

NCT01336387

Start Date:

October 2011

Completion Date:

Related Keywords:

  • Healthy, no Evidence of Disease

Name

Location

University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001