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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
361
Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase
Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
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 from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
Time frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV)
Progression Free Survival (PFS)
Time from randomization to first documentation of objective tumor progression or to death due to any cause (on treatment or within 28 days of last dose).
Time frame: Day 28 of each cycle : duration of double-blind treatment phase
Overall Survival Status of Subjects
Number of subjects alive at end of study.
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 from date of randomization to date of death due to any cause.
Time frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
Overall Survival Based on the Rank Preserving Structural Failure Time Method
time from date of randomization to date of death due to any cause (rank preserving structural failure time method).
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Pfizer Investigational Site
Duarte, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Pasadena, California, United States
Pfizer Investigational Site
Santa Monica, California, United States
Pfizer Investigational Site
Stanford, California, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Park Ridge, Illinois, United States
...and 51 more locations
Time frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
Best Overall Tumor Response During Double-blind Treatment Phase
Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST).
Time frame: Day 28 of each cycle : duration of double-blind treatment phase
Confirmed Objective Response (CR or PR) in Subjects
Overall confirmed objective response = confirmed Complete Response (CR) OR confirmed Partial Response (PR) according to RECIST. Confirmed responses were those that persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.
Time frame: Day 28 of each cycle : duration of double-blind treatment phase
Time to Tumor Response (TTR)
Time from date of randomization to first documentation of objective tumor response that was subsequently confirmed. TTR was only calculated for the subgroup of subjects with a confirmed objective tumor response.
Time frame: Day 28 of each cycle : duration of double-blind treatment phase
Duration of Performance Status Maintenance
Time from randomization until the last time the performance status was no worse than at baseline or to death due to cancer in the absence of previous documentation of performance status worsening.
Time frame: Day 28 of each cycle : duration of double-blind treatment phase
Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)
25th Quartile: Time to Progression. Progression: a) No change (NC) in MPQ-PPI score (0=no pain to 5=excruciating pain) with increase total analgesic use \>= 50% over baseline OR b) Increase score \>= 1 point with either NC in total analgesic use or increase total analgesic use \>= 50% over baseline. (50th Quartile not achieved.)
Time frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase
Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)
MPQ-PPI: 0=no pain to 5= excruciating pain. Pain Relief Response= 1) Decrease by \>= 1 points in MPQ-PPI score with either Decrease or No Change in total analgesic use \>= 50% over baseline OR 2) No change in MPQ-PPI score with Decrease total analgesic use \>= 50% over baseline.
Time frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase
Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS)
Change: median score at observation minus median score at baseline. EQ-VAS score on the self-rated "thermometer," indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.
Time frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase
Change From Baseline in EQ-5D Health State Profile Index
Change: median index score at observation minus median index score at baseline. EQ-5D is a generic instrument that describes health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where where 0.0 = death and 1.0 = perfect health.
Time frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase