Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331409
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2006-05-30
Brief Title:
Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Phase II Study of the Mammalian Target of Rapamycin mTOR Inhibitor RAD001 in Combination With Imatinib Mesylate in Patients With Previously Treated Advanced Renal Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-09
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 Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Everolimus may also block blood flow to the tumor Giving everolimus together with imatinib mesylate may kill more tumor cells
PURPOSE This phase II trial is studying how well giving everolimus together with imatinib mesylate works in treating patients with metastatic or unresectable kidney cancer
PURPOSE This phase II trial is studying how well giving everolimus together with imatinib mesylate works in treating patients with metastatic or unresectable kidney cancer
Detailed Description:
OBJECTIVES
Primary
Estimate the proportion of patients with previously treated metastatic or unresectable clear cell carcinoma of the kidney who are progression free complete response CR partial response PR or stable disease SD at 3 months after treatment with everolimus and imatinib mesylate
Secondary
Estimate median time to progression in patients treated with this regimen
Determine the proportion of patients whose best overall response are CR PR SD or progressive disease
Evaluate the mean and range of the maximum percent reduction in tumor size
Describe the toxicities of this regimen in these patients
OUTLINE This is an open-label multicenter study
Patients receive oral imatinib mesylate and oral everolimus once daily beginning on day 1 and continuing in the absence of disease progression
PROJECTED ACCRUAL A total of 43 patients will be accrued for this study
Primary
Estimate the proportion of patients with previously treated metastatic or unresectable clear cell carcinoma of the kidney who are progression free complete response CR partial response PR or stable disease SD at 3 months after treatment with everolimus and imatinib mesylate
Secondary
Estimate median time to progression in patients treated with this regimen
Determine the proportion of patients whose best overall response are CR PR SD or progressive disease
Evaluate the mean and range of the maximum percent reduction in tumor size
Describe the toxicities of this regimen in these patients
OUTLINE This is an open-label multicenter study
Patients receive oral imatinib mesylate and oral everolimus once daily beginning on day 1 and continuing in the absence of disease progression
PROJECTED ACCRUAL A total of 43 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000479150 | OTHER | NCI PDQ | None |
| OHSU-SOL-05108-LM | OTHER | None | None |
| FWA00000161 | OTHER | None | None |
| OHSU-1754 | OTHER | None | None |