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

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First Received on October 8, 2004. Last Updated on January 23, 2012 History of Changes

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00094029

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

Resource links provided by NLM:

Genetics Home Reference related topics: gastrointestinal stromal tumor

MedlinePlus related topics: Cancer

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Study Start Date:	September 2004
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Sutent, 25, 37.5, or 50 mg daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094029

Show 118 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dudeck O, Zeile M, Reichardt P, Pink D. Comparison of RECIST and Choi criteria for computed tomographic response evaluation in patients with advanced gastrointestinal stromal tumor treated with sunitinib. Ann Oncol. 2011 Aug;22(8):1828-33. Epub 2011 Feb 2.

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00094029 History of Changes
Other Study ID Numbers:	A6181036
Study First Received:	October 8, 2004
Last Updated:	January 23, 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 February 09, 2012