Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422344
Status:
COMPLETED
Last Update Posted:
2010-02-26
First Post:
2007-01-12
Brief Title:
A Study of RAD001 and Sunitinib in Metastatic Renal Cell Carcinoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Study of RAD001 and Sunitinib in Metastatic Renal Cell Carcinoma Patients
Status:
COMPLETED
Status Verified Date:
2010-02
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 purpose of this study is to test the safety of RAD-001 and Sunitinib given in combination for renal cell cancer We also want to find out what effects good and bad the combination of RAD-001 and Sunitinib have on you and your tumor
RAD001 is a pill that works by shutting down some of the pathways in the cell that make tumors grow Sunitinib is a pill that works by shutting off the signal in the cancer cells that tell the cells to grow blood vessels Without this signal the blood vessels to the tumors shrink down
RAD001 is a pill that works by shutting down some of the pathways in the cell that make tumors grow Sunitinib is a pill that works by shutting off the signal in the cancer cells that tell the cells to grow blood vessels Without this signal the blood vessels to the tumors shrink down
Detailed Description:
To assess the maximum tolerated doses and overall safety and tolerability of Sunitinib administered in combination with RAD001 for the treatment of patients with metastatic renal cell carcinoma
To assess antitumor activity of the combination of Sunitinib and RAD001
This study is designed to confirm that the 2 agents can be administered safely in combination Patients will begin treatment with Sunitinib and RAD001 on Day 1 RAD001 will be administered orally on a weekly schedule Sunitinib will be given orally on a 4 weeks on 2 weeks off schedule DLT determination will be based on toxicities observed in Cycle 1 - a cycle is defined by Sunitinib dosing 6 weeks Once the MTD for the combination has been identified a total of 10 patients will be enrolled at the highest dose level that allows for administration of multiple cycles and provides potentially therapeutic drug levels of both drugs to further assess safety and tolerability and to obtain a preliminary assessment of efficacy Patients will be treated with RAD001 and Sunitinib until there is disease progression significant toxicity or withdrawal of patient consent Patients judged to derive benefit from treatment would be offered participation in a continuation protocol at the conclusion of this study
To assess antitumor activity of the combination of Sunitinib and RAD001
This study is designed to confirm that the 2 agents can be administered safely in combination Patients will begin treatment with Sunitinib and RAD001 on Day 1 RAD001 will be administered orally on a weekly schedule Sunitinib will be given orally on a 4 weeks on 2 weeks off schedule DLT determination will be based on toxicities observed in Cycle 1 - a cycle is defined by Sunitinib dosing 6 weeks Once the MTD for the combination has been identified a total of 10 patients will be enrolled at the highest dose level that allows for administration of multiple cycles and provides potentially therapeutic drug levels of both drugs to further assess safety and tolerability and to obtain a preliminary assessment of efficacy Patients will be treated with RAD001 and Sunitinib until there is disease progression significant toxicity or withdrawal of patient consent Patients judged to derive benefit from treatment would be offered participation in a continuation protocol at the conclusion 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