Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384969
Status:
COMPLETED
Last Update Posted:
2014-08-18
First Post:
2006-10-03
Brief Title:
Sorafenib and RAD001 Renal Cell Carcinoma
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Phase I Study of Sorafenib and RAD001 in Patients With Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-08
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:
The objective of the phase I part of the study is to determine the maximum tolerated dose and dose limiting toxicities of the combination of RAD001 and sorafenib in patients with untreated metastatic kidney cancer
Detailed Description:
Phase I of the study will be an open-label dose escalation study to determine the MTD of the combination of sorafenib and RAD001 There will be a 7-day sorafenib run-in period prior to starting of RAD001 during cycle 1 to determine the pharmacokinetic effect of adding RAD001 on sorafenib drug levels Starting doses will be set at RAD001 25 mg PO QD and sorafenib 400mg PO BID continuously Cycle length will be 4 weeks Between 3 and 18 patients will be treated in the phase I portion of 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