Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100958
Status:
COMPLETED
Last Update Posted:
2008-07-24
First Post:
2005-01-07
Brief Title:
Indole-3-Carbinol in Preventing Cancer in Healthy Participants
Sponsor:
University of Kansas
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Ascending Single Dose Pharmacokinetics PK and Safety Study of 33 Di-Indolymethane DIM Nutritional Product
Status:
COMPLETED
Status Verified Date:
2006-05
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:
RATIONALE Chemoprevention is the use of certain drugs to keep cancer from forming growing or coming back The use of indole-3-carbinol may prevent cancer
PURPOSE This randomized phase I trial is studying the side effects and best dose of indole-3-carbinol and to see how well it works compared to placebo in preventing cancer in healthy participants
PURPOSE This randomized phase I trial is studying the side effects and best dose of indole-3-carbinol and to see how well it works compared to placebo in preventing cancer in healthy participants
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of indole-3-carbinol in healthy participants
Determine the safety and tolerability of this drug in these participants
Determine the pharmacokinetics of this drug in these participants
Secondary
Determine the effects of this drug on selected markers of sexual function in these participants
Determine the effects of this drug on markers of susceptibility to cancer in these participants
OUTLINE This is a randomized double-blind placebo-controlled dose-escalation study Participants at each dose level are randomized to 1 of 2 treatment arms
Arm I Participants receive a single dose of oral indole-3-carbinol on day 1
Arm II Participants receive a single dose of oral placebo on day 1 Cohorts of 3 participants receive escalating doses of indole-3-carbinol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity An additional cohort of 3 participants is treated at the MTD
Participants are followed on days 2 3 and 6
PROJECTED ACCRUAL A total of 24 participants 18 in arm I and 6 in arm II will be accrued for this study
Primary
Determine the maximum tolerated dose of indole-3-carbinol in healthy participants
Determine the safety and tolerability of this drug in these participants
Determine the pharmacokinetics of this drug in these participants
Secondary
Determine the effects of this drug on selected markers of sexual function in these participants
Determine the effects of this drug on markers of susceptibility to cancer in these participants
OUTLINE This is a randomized double-blind placebo-controlled dose-escalation study Participants at each dose level are randomized to 1 of 2 treatment arms
Arm I Participants receive a single dose of oral indole-3-carbinol on day 1
Arm II Participants receive a single dose of oral placebo on day 1 Cohorts of 3 participants receive escalating doses of indole-3-carbinol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity An additional cohort of 3 participants is treated at the MTD
Participants are followed on days 2 3 and 6
PROJECTED ACCRUAL A total of 24 participants 18 in arm I and 6 in arm II will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KUMC-HSC-9139-2 | None | None | None |