Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445042
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2007-03-07
Brief Title:
Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
A Phase II Study of Sorafenib in 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 determine the safety and toxicity levels of Dose Escalated Sorafenib in the treatment of patients with renal cancer
Detailed Description:
Because tumors may have multiple mechanisms to induce angiogenesis blockade with sorafenib may demonstrate efficacy Doses of sorafenib 400 mg bid as a single agent is with minimal toxicity presents an opportunity to explore a more intensive drug administration This study will allow individual patient titration eg intrapatient dose escalation as per protocol
This provides the basis for the dose escalation development of sorafenib The study is designed to evaluate the ability for patients to dose escalate Secondary endpoints include response time to progression and overall survival in patients with MRCC Tissue correlation to evaluate the impact of expression of receptor on clinical outcome will be retrospectively performed Laboratory correlation of plasma VEGF levels will be correlated and evaluated to clinical outcome
This provides the basis for the dose escalation development of sorafenib The study is designed to evaluate the ability for patients to dose escalate Secondary endpoints include response time to progression and overall survival in patients with MRCC Tissue correlation to evaluate the impact of expression of receptor on clinical outcome will be retrospectively performed Laboratory correlation of plasma VEGF levels will be correlated and evaluated to clinical outcome
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 |
|---|---|---|---|
| Sorafenib-RCC-01 | None | None | None |