Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096317
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2004-11-09
Brief Title:
Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
The Effect of Ketoconazole on the Pharmacokinetics and Pharmacodynamics of Ixabepilone In Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2018-10
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 Drugs used in chemotherapy such as ixabepilone and ketoconazole work in different ways to stop tumor cells from dividing so they stop growing or die Giving ixabepilone with ketoconazole may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of giving ixabepilone together with ketoconazole and to see how well they work in treating patients with advanced solid tumors
PURPOSE This phase III trial is studying the side effects and best dose of giving ixabepilone together with ketoconazole and to see how well they work in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the effect of ketoconazole on the pharmacokinetics of ixabepilone in patients with advanced solid tumors
Secondary
Determine the safety of ixabepilone when administered alone and in combination with ketoconazole in these patients
Determine preliminarily the antitumor activity of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of ixabepilone
During course 1 patients receive oral ketoconazole on days 0-5 and ixabepilone IV over 3 hours on day 1 During course 2 and subsequent courses patients receive only ixabepilone IV over 3 hours on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of at least 3 patients receive escalating doses of ixabepilone during course 1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity At least 12 patients are treated at the MTD
PROJECTED ACCRUAL A total of 3-35 patients will be accrued for this study
Primary
Determine the effect of ketoconazole on the pharmacokinetics of ixabepilone in patients with advanced solid tumors
Secondary
Determine the safety of ixabepilone when administered alone and in combination with ketoconazole in these patients
Determine preliminarily the antitumor activity of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of ixabepilone
During course 1 patients receive oral ketoconazole on days 0-5 and ixabepilone IV over 3 hours on day 1 During course 2 and subsequent courses patients receive only ixabepilone IV over 3 hours on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of at least 3 patients receive escalating doses of ixabepilone during course 1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity At least 12 patients are treated at the MTD
PROJECTED ACCRUAL A total of 3-35 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AECM-NMC-03-10-277C | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA013330 |
| P30CA013330 | NIH | None | None |
| AECM-03099 | None | None | None |
| AECM-CA163402 | None | None | None |