Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392821
Status:
COMPLETED
Last Update Posted:
2022-06-06
First Post:
2006-10-25
Brief Title:
Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
Phase III Trial of Sorafenib Nexavar and RAD001 Everolimusin the Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2022-05
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 study is being done in 2 parts The first part is to determine the dose of RAD001 that should be used in combination with sorafenib The second part is using the above determined dose of RAD001 in combination with sorafenib to see how effective these 2 drugs are against advanced kidney cancer
Participants will be asked to keep a pill diary
Participants will be asked to keep a pill diary
Detailed Description:
The drugs used in this trial are called targeted drugs as they target specific activities that are carried out by cancer cells that make them grow and spread Sorafenib is an approved drug for the treatment of advanced kidney cancer RAD001 is an experimental drug that has been used in other research studies with other types of cancer In this trial the use of RAD001 and sorafenib together for the treatment of kidney cancer is experimental In the Phase I portion of this study 13-16 patients will be treated with the same dose of sorafenib and different doses of RAD001 The purpose is to see what is a safe dose of RAD001 when combined with sorafenib in the treatment of kidney cancer Once this dose of RAD001 is determined about 65 more patients will be treated to see how effective this combination of drugs is against this kidney cancer
Both of these drugs are taken by mouth Sorafenib will be taken twice a day RAD001 is taken by mouth weekly Patients will be able to continue treatment as long as their disease does not worsen or side effects become intolerable
Both of these drugs are taken by mouth Sorafenib will be taken twice a day RAD001 is taken by mouth weekly Patients will be able to continue treatment as long as their disease does not worsen or side effects become intolerable
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 |
|---|---|---|---|
| CRAD001C2480 | None | None | None |