A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Gastrointestinal Neoplasm |
Drug: Sutent |
| Study Type: | Expanded Access What is Expanded Access? |
| 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 |
| Study Start Date: | September 2004 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
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Drug: Sutent
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically proven Gastrointestinal Stomal Tumor (GIST) that is not amenable to standard therapy
- Undergone screening and found to be ineligible for participation in ongoing SU011248 clinical studies
- Patient judged to have potential to derive clinical benefit from SU011248 treatment by the treating physician
- Failed prior treatment with imatinib mesylate, defined as either progression of disease or significant toxicity during treatment with imatinib mesylate that precluded further treatment
- Male or Female, 18 years or older
- Resolution of all acute toxicities of prior therapies
- Adequate organ function
Exclusion Criteria:
- Symptomatic congestive heart failure, myocardial infarction, or coronary artery bypass graft in the last 6 months, or ongoing severe or unstable angina or any unstable arrhythmia requiring medication
- Symptomatic central nervous system metastases
- Serious acute or chronic illness
- Current treatment on another clinical trial
- Pregnant or breastfeeding.
Contacts and Locations
Show 118 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00094029 History of Changes |
| Other Study ID Numbers: | A6181036 |
| Study First Received: | October 8, 2004 |
| Last Updated: | March 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Gastrointestinal Stromal Tumors Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Sunitinib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013