Ignite Creation Date:
2024-05-05 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005995
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
2000-07-05
Brief Title:
AE-941 in Treating Patients With Metastatic Kidney Cancer
Sponsor:
AEterna Zentaris
Organization:
AEterna Zentaris
Study Overview
Official Title:
AE-941 NEOVASTAT Versus Placebo in Metastatic Renal Cell Carcinoma Patients Who Are Refractory to Immunotherapy
Status:
COMPLETED
Status Verified Date:
2008-02
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 AE-941 may stop the growth of kidney cancer by stopping blood flow to the tumor
PURPOSE Randomized phase III trial to determine the effectiveness of AE-941 in treating patients who have metastatic kidney cancer that has not responded to biological therapy
PURPOSE Randomized phase III trial to determine the effectiveness of AE-941 in treating patients who have metastatic kidney cancer that has not responded to biological therapy
Detailed Description:
OBJECTIVES I Compare survival of patients with metastatic renal cell carcinoma refractory to immunotherapy treated with AE-941 Neovastat versus placebo II Compare the time to progression and one-year survival rate of patients treated with this regimen III Determine the safety of this regimen in these patients IV Compare the overall tumor response rate duration of response and quality of life of patients treated with this regimen
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to number of organs with metastases 1 vs more than 1 and ECOG performance status 0 vs 1 Patients are randomized to one of two treatment arms Arm I Patients receive oral AE-941 Neovastat twice a day Arm II Patients receive oral placebo twice a day Treatment continues in the absence of unacceptable toxicity or disease progression Quality of life is assessed on day 1 and then every 8 weeks thereafter Patients are followed every 4 weeks until disease progression and then every 8 weeks thereafter
PROJECTED ACCRUAL A total of 280 patients will be accrued for this study within 12 months
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to number of organs with metastases 1 vs more than 1 and ECOG performance status 0 vs 1 Patients are randomized to one of two treatment arms Arm I Patients receive oral AE-941 Neovastat twice a day Arm II Patients receive oral placebo twice a day Treatment continues in the absence of unacceptable toxicity or disease progression Quality of life is assessed on day 1 and then every 8 weeks thereafter Patients are followed every 4 weeks until disease progression and then every 8 weeks thereafter
PROJECTED ACCRUAL A total of 280 patients will be accrued for this study within 12 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UPCC-2800 | None | None | None |
| CAN-CCI-ETH-00-32-17 | None | None | None |
| UCMC-0006305 | None | None | None |
| AETERNA-AE-RC-99-02 | None | None | None |
| CCF-IRB-3664 | None | None | None |
| JGH-00023 | None | None | None |