Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094029
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2012-03-09
First Post:
2004-10-08
Brief Title:
A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor GIST Who May Derive Benefit From Treatment With SU011248
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions a patients undergo screening but are not eligible for participation in ongoing clinical studies such as A6181004 AND b patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c patients have the potential to derive clinical benefit from treatment with SU011248
Detailed Description:
Given that an Expanded Access study does not meet the definition of a controlled clinical investigation and as such is not considered an applicable drug clinical trial per NIH Basic Results for such studies are not required to be reported Protocol A6181036 has been identified as an Expanded Access trial and has been registered to ClinicalTrialsgov however Basic Results will not be posted
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