Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267748
Status:
COMPLETED
Last Update Posted:
2011-09-05
First Post:
2005-12-20
Brief Title:
Sunitinib Malate Schedule 42 vs Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer RCC
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Randomized Phase II Study Of The Efficacy And Safety Of Sunitinib Malate Schedule 42 vs Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer Renal EFFECT Trial
Status:
COMPLETED
Status Verified Date:
2011-08
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:
This trial has two parts The purpose of the first part of the trial is to determine the doses of 2 drugs sunitinib malate and interferon alfa-2b that can be given safely in combination This part is currently closed to enrollment
The purpose of the second part of the trial is to see if sunitinib malate given on a 42 schedule 4 weeks on treatment 2 weeks off treatment cycle is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule The trial will also determine the number of patients whose cancer responds to the treatments whether life of patients can be extended what the side effects are of the treatments how bothersome disease or treatment-related symptoms are to patients and whether tests can be found that will predict which patients may or may not respond to these treatments in the future
The purpose of the second part of the trial is to see if sunitinib malate given on a 42 schedule 4 weeks on treatment 2 weeks off treatment cycle is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule The trial will also determine the number of patients whose cancer responds to the treatments whether life of patients can be extended what the side effects are of the treatments how bothersome disease or treatment-related symptoms are to patients and whether tests can be found that will predict which patients may or may not respond to these treatments in the future
Detailed Description:
None
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