Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT00854620
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2009-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
A Phase 2 Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma at Stanford University
Status:
COMPLETED
Status Verified Date:
2015-05
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:
Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib
Detailed Description:
Sorafenib to be administered as 28-day cycles.
Sorafenib dose escalation by cycle is:
* Cycle 1: 400 mg BID
* Cycle 2: 600 mg BID
* Cycle 3+: 800 mg BID
Within subject dose escalation and maximum dose is dependent on observed tolerability.
Dose escalation only occurs after acceptable tolerability is demonstrated by subject.
Sorafenib dose escalation by cycle is:
* Cycle 1: 400 mg BID
* Cycle 2: 600 mg BID
* Cycle 3+: 800 mg BID
Within subject dose escalation and maximum dose is dependent on observed tolerability.
Dose escalation only occurs after acceptable tolerability is demonstrated by subject.
Study Oversight
Has Oversight DMC:
True
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?: