Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-03-03 @ 10:03 AM
Study NCT ID:
NCT01935960
Status:
COMPLETED
Last Update Posted:
2016-12-23
First Post:
2013-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinoid 9cUAB30 in Preventing Cancer in Healthy Volunteers
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Phase I Dose-Escalation Study of the Novel Retinoid 9cUAB30
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the toxicities and recommended phase II dose of 9cUAB30 (retinoid 9cUAB30).
II. 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 pharmacokinetics (PK) after repeat dosing (day 1 vs. day 36).
OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 2 treatment arms.
ARM I: Participants receive retinoid 9cUAB30 orally (PO) once daily (QD) on days 1 and 8-36. Treatment continues in the absence of unacceptable toxicity.
ARM II: Participants receive a placebo PO QD on days 1 and 8-36.
After completion of study treatment, patients are followed up at 7 and 30 days.
I. To determine the toxicities and recommended phase II dose of 9cUAB30 (retinoid 9cUAB30).
II. 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 pharmacokinetics (PK) after repeat dosing (day 1 vs. day 36).
OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 2 treatment arms.
ARM I: Participants receive retinoid 9cUAB30 orally (PO) once daily (QD) on days 1 and 8-36. Treatment continues in the absence of unacceptable toxicity.
ARM II: Participants receive a placebo PO QD on days 1 and 8-36.
After completion of study treatment, patients are followed up at 7 and 30 days.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-01655 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| UW13022 | OTHER | University of Wisconsin Chemoprevention Consortium | View | |
| UWI10-16-01R | OTHER | DCP | View | |
| N01CN35153 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA014520 | NIH | None | https://reporter.nih.gov/quic… | View |