Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039169
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2002-06-06
Brief Title:
BAY 59-8862 in Treating Patients With Advanced Kidney Cancer
Sponsor:
Theradex
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Uncontrolled Phase II Multi-Center Trial Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Advanced Renal Cell Cancer
Status:
UNKNOWN
Status Verified Date:
2008-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have advanced kidney cancer
PURPOSE Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have advanced kidney cancer
Detailed Description:
OBJECTIVES
Determine the overall tumor response rate including complete response CR and partial response PR rate in patients with advanced renal cell cancer treated with BAY 59-8862
Determine the overall survival in patients treated with this drug
Determine the time to progression in patients treated with this drug
Determine the duration of response CR and PR in patients treated with this drug
Determine the qualitative and quantitative toxicity profile of this drug in this patient population
Determine the pharmacokinetic profile of this drug in selected patients
OUTLINE This is a multicenter study
Patients receive BAY 59-8862 IV over 1 hour on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months thereafter or for up to 2 years
PROJECTED ACCRUAL A total of 20-140 patients will be accrued for this study
Determine the overall tumor response rate including complete response CR and partial response PR rate in patients with advanced renal cell cancer treated with BAY 59-8862
Determine the overall survival in patients treated with this drug
Determine the time to progression in patients treated with this drug
Determine the duration of response CR and PR in patients treated with this drug
Determine the qualitative and quantitative toxicity profile of this drug in this patient population
Determine the pharmacokinetic profile of this drug in selected patients
OUTLINE This is a multicenter study
Patients receive BAY 59-8862 IV over 1 hour on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months thereafter or for up to 2 years
PROJECTED ACCRUAL A total of 20-140 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 |
|---|---|---|---|
| BAYER-100386 | None | None | None |
| THERADEX-100386 | None | None | None |