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

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	Phase
Gastrointestinal Neoplasm	Drug: SU011248	Phase III

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Sunitinib Sunitinib malate Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to Tumor Progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Overall Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	1400
Study Start Date:	September 2004
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
sunitinib: Experimental sutent, 25, 37.5, or 50 mg daily	Drug: SU011248 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

Contacts


Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com

Show 115 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181036
First Received:	October 8, 2004
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00094029
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Imatinib

Digestive System Diseases

Digestive System Neoplasms

Sunitinib

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Gastrointestinal Stromal Tumors

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Antineoplastic Agents

Growth Substances

Therapeutic Uses

Physiological Effects of Drugs

Growth Inhibitors

Angiogenesis Modulating Agents

Angiogenesis Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00094029