Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040989
Status:
WITHDRAWN
Last Update Posted:
2013-07-10
First Post:
2002-07-08
Brief Title:
BAY 56-3722 in Treating Patients With Recurrent Unresectable or Metastatic Kidney Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of BAY 56-3722 in Patients With Recurrent Unresectable or Metastatic Renal Cell Carcinoma
Status:
WITHDRAWN
Status Verified Date:
2006-12
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 BAY 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth
PURPOSE Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who have recurrent unresectable or metastatic kidney cancer
PURPOSE Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who have recurrent unresectable or metastatic kidney cancer
Detailed Description:
OBJECTIVES
Determine the tumor response rate of patients with recurrent unresectable or metastatic renal cell carcinoma treated with BAY 56-3722
Determine the duration of response time to progression and survival of patients treated with this drug
Determine the qualitative and quantitative toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter study
Patients receive BAY 56-3722 IV over 30 minutes on days 1-3 Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 20-140 patients will be accrued for this study
Determine the tumor response rate of patients with recurrent unresectable or metastatic renal cell carcinoma treated with BAY 56-3722
Determine the duration of response time to progression and survival of patients treated with this drug
Determine the qualitative and quantitative toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter study
Patients receive BAY 56-3722 IV over 30 minutes on days 1-3 Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 20-140 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069432 | REGISTRY | None | None |
| UTHSC-0125011152 | None | None | None |
| BAYER-100364 | None | None | None |
| NCI-G02-2090 | Registry Identifier | PDQ Physician Data Query | None |