Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448149
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2007-03-15
Brief Title:
Phase III Trial of RAD001 Plus Nexavar in Patients With Kidney Cancer
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Phase III Trial of RAD001 Plus Nexavar For Patients With Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-03
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 see whether the combination for RAD001 and Nexavar works better when given together than they do alone The purpose of the first phase of this study is to determine the best dose of RAD001 given with Nexavar and to see what effects good andor bad the study drug has on the subject and the subjects tumor This study will also observe side effects experienced by the subject
Detailed Description:
Despite significant progress in understanding the biology of renal cell carcinoma RCC it is estimated that over 35 000 people in the United States will be diagnosed and approximately 12 000 have died from this disease in 2005 Renal cell carcinoma presently ranks tenth as the leading cause of cancer death and constitutes 3 of all solid neoplasms
In contrast to many other malignancies treatment for RCC is limited Treatment remains a highly difficult and perplexing challenge due to its resistance to both chemotherapy and hormone therapy and limited response to cytokines Despite recent advances in our fundamental knowledge of RCC biology and development of molecular therapeutics more clinical research will be required to best guide our use of these exciting new agents in combination regimens
The combination of RAD001 and Nexavar in current clinical trials with minimal toxicity represents a treatment regimen which should be investigated for tolerance and toxicity as well as initial phase II efficacy The study is designed to evaluate the MTD Following the completion of the phase I utilizing the MTD Phase II study is designed to evaluate the anti-tumor activity
In contrast to many other malignancies treatment for RCC is limited Treatment remains a highly difficult and perplexing challenge due to its resistance to both chemotherapy and hormone therapy and limited response to cytokines Despite recent advances in our fundamental knowledge of RCC biology and development of molecular therapeutics more clinical research will be required to best guide our use of these exciting new agents in combination regimens
The combination of RAD001 and Nexavar in current clinical trials with minimal toxicity represents a treatment regimen which should be investigated for tolerance and toxicity as well as initial phase II efficacy The study is designed to evaluate the MTD Following the completion of the phase I utilizing the MTD Phase II study is designed to evaluate the anti-tumor activity
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 |
|---|---|---|---|
| RCC-06-102 | OTHER | Principal Investigator | None |