Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389285
Status:
COMPLETED
Last Update Posted:
2009-05-27
First Post:
2006-10-16
Brief Title:
Study of Recombinant Interleukin 21 in Combination With Sorafenib for Metastatic Renal Cell Carcinoma
Sponsor:
ZymoGenetics
Organization:
ZymoGenetics
Study Overview
Official Title:
A Phase 12 Open-Label Dose Escalation Study to Assess the Safety and Pharmacokinetics of Recombinant Interleukin 21 rIL-21 Administered Concomitantly With Sorafenib Nexavar in Subjects With Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2009-05
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:
The purpose of the study is to evaluate whether recombinant IL-21 used in combination with sorafenib is safe for patients with metastatic renal cell carcinoma RCC
Detailed Description:
This is a Phase 12 open-label dose-escalation study of rIL-21 given in combination with sorafenib to patients with metastatic RCC The Phase 1 part of this study will estimate the maximum tolerated dose of rIL-21 given for 1 treatment course consisting of two 5-day cycles of rIL-21 in combination with a standard dose of sorafenib administered during a 6-week treatment course Increasing doses of rIL-21 will be studied sequentially in different groups of patients The Phase 2 part of the study will further evaluate the safety and preliminary antitumor activity of rIL-21 at the dose recommended from Phase 1 in combination with sorafenib Patients will be evaluated for safety over the course of the study Disease evaluation tumor restaging will be performed during the last week of each 6-week treatment course Patients with stable disease or better at this evaluation may go on to receive additional treatment courses Patients may be in the study for 2 to 7 months
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