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

Tracking Information

First Received Date ^ICMJE

January 6, 2004

Last Updated Date

August 31, 2009

Start Date ^ICMJE

December 2003

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase [ Time Frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study [ Time Frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Information was omitted due to their commercial sensitivity and will be revealed at a later date.

Change History

Complete list of historical versions of study NCT00075218 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Progression Free Survival (PFS) [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
Overall Survival Status of Subjects [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ] [ Designated as safety issue: No ]
Overall Survival Based on the Rank Preserving Structural Failure Time Method [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ] [ Designated as safety issue: No ]
Best Overall Tumor Response During Double-blind Treatment Phase [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
Confirmed Objective Response (CR or PR) in Subjects [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
Time to Tumor Response (TTR) [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
Duration of Performance Status Maintenance [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS) [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]
Change From Baseline in EQ-5D Health State Profile Index [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Other anti-tumor assessments safety

Descriptive Information

Brief Title ^ICMJE

A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)

Official Title ^ICMJE

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

Brief Summary

A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Gastrointestinal Stromal Tumor

Intervention ^ICMJE

Drug: Placebo
Drug: SU011248

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

361

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Key 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

Key Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, Canada, France, Italy, Netherlands, Singapore, Spain, Switzerland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00075218

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer Inc

Study ID Numbers ^ICMJE

A6181004

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP