Clinical trial NCT00075218: A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Stromal Tumor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-01-08
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase
timeFrame: Day 28 of each 6-week cycle : duration of double-blind treatment phase
measure: Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study
timeFrame: Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV)
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Day 28 of each cycle : duration of double-blind treatment phase
measure: Overall Survival Status of Subjects
timeFrame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
measure: Overall Survival
timeFrame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
measure: Overall Survival Based on the Rank Preserving Structural Failure Time Method
timeFrame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
measure: Best Overall Tumor Response During Double-blind Treatment Phase
timeFrame: Day 28 of each cycle : duration of double-blind treatment phase
measure: Confirmed Objective Response (CR or PR) in Subjects
timeFrame: Day 28 of each cycle : duration of double-blind treatment phase
measure: Time to Tumor Response (TTR)
timeFrame: Day 28 of each cycle : duration of double-blind treatment phase
measure: Duration of Performance Status Maintenance
timeFrame: Day 28 of each cycle : duration of double-blind treatment phase
measure: Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)
timeFrame: Day 1 & 28 of each cycle : duration of double-blind treatment phase
measure: Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)
timeFrame: Day 1 & 28 of each cycle : duration of double-blind treatment phase
measure: Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS)
timeFrame: Day 1 & 28 of each cycle : duration of double-blind treatment phase
measure: Change From Baseline in EQ-5D Health State Profile Index
timeFrame: Day 1 & 28 of each cycle : duration of double-blind treatment phase
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Stanford
country: United States
facility: Pfizer Investigational Site
state: California
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Park Ridge
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columubs
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Garran
country: Australia
facility: Pfizer Investigational Site
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Randwick
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Auchenflower
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Ashford
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Bedford Park
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: East Melbourne
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: VILLEJUIF Cedex
country: France
facility: Pfizer Investigational Site
city: Aviano
country: Italy
facility: Pfizer Investigational Site
state: PN
city: Candiolo
country: Italy
facility: Pfizer Investigational Site
state: Torino
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Groningen
country: Netherlands
facility: Pfizer Investigational Site
state: Gr
city: Rotterdam
country: Netherlands
facility: Pfizer Investigational Site
state: ZH
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: L'Hospitalet del Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Lausanne
country: Switzerland
facility: Pfizer Investigational Site
city: Sutton
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1016/S0140-6736(06)69446-4.