Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226811
Status:
COMPLETED
Last Update Posted:
2015-03-30
First Post:
2005-09-23
Brief Title:
An International Phase 2 Study Of SU011248 In Patients With Advanced Metastatic Gastric Cancer Failing Chemotherapy
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Advanced Metastatic Gastric Cancer Progressing Or Recurring After One Prior Chemotherapy
Status:
COMPLETED
Status Verified Date:
2015-03
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:
The study consisted of two parts In Part 1 the study enrolled 38 patients Step 1 Simon 2 step design after which Step 2 was opened and the total enrollment target for the study n63 was exceeded due to a rapid enrollment 78 patients were entered Part 2 of the study did not open due to the final overall insufficiency of efficacy observed in 78 patients Sunitinib SU011248 was administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg with provision for dose reduction based on tolerability All patients received repeated cycles of sunitinib until disease progression occurrence of unacceptable toxicity or other withdrawal criteria were met After discontinuation of treatment patients were followed up in order to collect information on further antineoplastic therapy and survival
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