A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumors (GIST) - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00075218

Purpose

A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumors (GIST) who have failed Gleevec therapy or who were intolerant to Gleevec treatment.

Condition	Intervention	Phase
Gastrointestinal Stromal Tumors	Drug: SU011248 Drug: Placebo	Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Sunitinib Sunitinib malate Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

Further study details as provided by Pfizer:

Primary Outcome Measures:

Time to tumor progression as assessed by imaging studies [ Time Frame: 6 wk interval ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma protein levels [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Progression Free Survival [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Objective Response Rate [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Time to Tumor Response [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Duration of performance status maintenance [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Measurement of clinical benefit related parameters: Pain relief, investigator related changes in severity of other baseline tumor related signs and symptoms, patient reported outcomes [ Time Frame: Duration of blinded portion of study ] [ Designated as safety issue: No ]
PK [ Time Frame: Duration of blinded portion of study ] [ Designated as safety issue: No ]
Safety [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Enrollment:	357
Study Start Date:	December 2003
Estimated Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: SU011248 50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
B: Placebo Comparator	Drug: Placebo 50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.

Eligibility

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

Criteria

Inclusion Criteria:

Histologically-proven diagnosis of malignant GIST not amenable to surgery, radiation or combined modality treatment with curative intent
Failed Gleevec treatment or intolerant to Gleevec therapy

Exclusion Criteria:

Treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational agent since the last dose of Gleevec

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075218

Show 61 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

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006 Oct 14;368(9544):1329-38.

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181004
Study First Received:	January 6, 2004
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00075218
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 January 16, 2009