Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021021
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
2001-07-11
Brief Title:
RPI4610 in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Ribozyome
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Open-Label Multicenter Trial of Angiozyme in Subjects With Metastatic Renal Cell Cancer
Status:
COMPLETED
Status Verified Date:
2002-05
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:
RATIONALE RPI4610 may stop the growth of metastatic kidney cancer by stopping blood flow to the tumor
PURPOSE Phase II trial to study the effectiveness of RPI4610 in treating patients who have metastatic kidney cancer
PURPOSE Phase II trial to study the effectiveness of RPI4610 in treating patients who have metastatic kidney cancer
Detailed Description:
OBJECTIVES I Determine the response rate of patients with metastatic renal cell cancer treated with RPI4610 II Determine the percentage of these patients with stable disease at 16 weeks after starting treatment with this drug III Assess the safety and tolerability of this drug in these patients
OUTLINE This is a multicenter study Patients receive RPI4610 subcutaneously daily Treatment continues for 16 weeks in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may continue treatment after 16 weeks Patients are followed every 3 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive RPI4610 subcutaneously daily Treatment continues for 16 weeks in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may continue treatment after 16 weeks Patients are followed every 3 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-G01-1975 | None | None | None |
| UCLA-001201501 | None | None | None |
| RPI-0004 | None | None | None |