A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248

Gastrointestinal Neoplasm Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ClinicalTrials.gov, however Basic Results will not be posted. ;

Study Design

N/A

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasm
• Gastrointestinal Neoplasms
• Gastrointestinal Stromal Tumors

• NCT number: NCT00094029
• Study type: Expanded Access
• Source: Pfizer
• Status: Approved for marketing
• Phase: N/A
• Start date: September 2004
• Completion date: October 2011