Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098501
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2004-12-07
Brief Title:
CCI-779 and EKB-569 in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1 Trial of CCI-779 in Combination With EKB-569 an EGFR Inhibitor in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
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 phase I trial is studying the side effects best way to give and best dose of CCI-779 and EKB-569 in treating patients with advanced solid tumors Drugs used in chemotherapy such as CCI-779 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing EKB-569 may stop the growth of tumor cells by blocking some of the enzymes needed for their growth Giving CCI-779 together with EKB-569 may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of the combination of CCI-779 and EKB-569 in patients with advanced solid tumors
II Determine the toxicity of this regimen in these patients III Determine the response rate in patients treated with this regimen
OUTLINE This is a dose-escalation study Patients are assigned to 1 of 3 treatment groups
Group I Patients receive oral EKB-569 on days 1-28 and oral CCI-779 on days 1-7 and 15-21
Cohorts of 3-6 patients receive escalating doses of EKB-569 and CCI-779 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Group II Patients receive oral EKB-569 at the MTD on days 4-28 of course 1 and days 1-28 of all subsequent courses and CCI-779 at the MTD on days 1-3 and 15-17
Group III Patients receive EKB-569 at the MTD as in group I and oral CCI-779 at the MTD on days 7-9 and 19-21 of course 1 and days 1-3 and 15-17 of all subsequent courses
In all groups courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 30-42 patients 18-30 for group I 6 for group II and 6 for group III will be accrued for this study within 135-175 years
I Determine the maximum tolerated dose of the combination of CCI-779 and EKB-569 in patients with advanced solid tumors
II Determine the toxicity of this regimen in these patients III Determine the response rate in patients treated with this regimen
OUTLINE This is a dose-escalation study Patients are assigned to 1 of 3 treatment groups
Group I Patients receive oral EKB-569 on days 1-28 and oral CCI-779 on days 1-7 and 15-21
Cohorts of 3-6 patients receive escalating doses of EKB-569 and CCI-779 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Group II Patients receive oral EKB-569 at the MTD on days 4-28 of course 1 and days 1-28 of all subsequent courses and CCI-779 at the MTD on days 1-3 and 15-17
Group III Patients receive EKB-569 at the MTD as in group I and oral CCI-779 at the MTD on days 7-9 and 19-21 of course 1 and days 1-3 and 15-17 of all subsequent courses
In all groups courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 30-42 patients 18-30 for group I 6 for group II and 6 for group III will be accrued for this study within 135-175 years
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MC027C | None | None | None |
| NCI-6200 | None | None | None |
| MAYO-MC027C | None | None | None |
| CDR0000398176 | None | None | None |
| U01CA069912 | NIH | None | httpsreporternihgovquickSearchU01CA069912 |