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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00075218
• Date of registration: 06/01/2004
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)
• Scientific 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
• Date of first enrolment: December 2003
• Target sample size: 361
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00075218
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Gastrointestinal Stromal Tumor

Intervention(s)

Drug: Placebo

Drug: SU011248

Primary Outcome(s)

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]

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)]

Secondary Outcome(s)

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]

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]

Overall Survival [Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug]

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]

Progression Free Survival (PFS) [Time Frame: Day 28 of each cycle : duration of double-blind treatment phase]

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]

Best Overall Tumor Response During Double-blind Treatment Phase [Time Frame: Day 28 of each cycle : duration of double-blind treatment phase]

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]

Duration of Performance Status Maintenance [Time Frame: Day 28 of each cycle : duration of double-blind treatment phase]

Change From Baseline in EQ-5D Health State Profile Index [Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase]

Time to Tumor Response (TTR) [Time Frame: Day 28 of each cycle : duration of double-blind treatment phase]

Confirmed Objective Response (CR or PR) in Subjects [Time Frame: Day 28 of each cycle : duration of double-blind treatment phase]

Secondary ID(s)

A6181004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/09/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00075218