Dose-Finding of Retinoid 9cUAB30 in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT01336387 |
Recruitment Status
:
Terminated
First Posted
: April 15, 2011
Last Update Posted
: October 9, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | March 24, 2011 | |||
First Posted Date ICMJE | April 15, 2011 | |||
Last Update Posted Date | October 9, 2014 | |||
Study Start Date ICMJE | October 2011 | |||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Dose level of UAB30 [ Time Frame: Day 43 ] The dose level of UAB30 to be used in future studies will be determined.
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Change History | Complete list of historical versions of study NCT01336387 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Dose-Finding of Retinoid 9cUAB30 in Healthy Volunteers | |||
Official Title ICMJE | A Randomized, Double-Blind, Single-dose and Multi-dose Study of the Novel Retinoid, 9cUAB30, to Determine Pharmacokinetics and Safety | |||
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. | |||
Detailed 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:
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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Healthy, no Evidence of Disease | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
50 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | September 2012 | |||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01336387 | |||
Other Study ID Numbers ICMJE | NCI-2013-00468 CO10311 N01CN35153 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | National Cancer Institute (NCI) | |||
Study Sponsor ICMJE | National Cancer Institute (NCI) | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Cancer Institute (NCI) | |||
Verification Date | May 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |