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

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

Population: From the Intent to Treat (ITT) population, 82 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 67 subjects on placebo were observed to have disease progression during blinded 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 after Last Subject Last Visit (LSLV)

Population: From the Intent to Treat (ITT) population, 91 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 73 subjects on placebo were observed to have disease progression during blinded 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

Population: ITT population

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

Population: ITT Population. Number subjects with evaluable data: (n=sunitinib, placebo)

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

Population: ITT population. Number subjects with evaluable data: (n=sunitinib, placebo)

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

Population: ITT population.

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

Population: ITT Population. Number of subjects at median observed to have status worsening or died before status worsening.

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

Population: ITT population; Number subjects Dead = 176, 90 (sunitinib, placebo respectively). Subjects who were not known to be dead at the time the database was closed for analysis were censored on the date they were last known to be alive.

time from date of randomization to date of death due to any cause (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

Population: ITT population

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

Population: ITT population.

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

Population: ITT population

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

Population: Pain-Relief-Response population.

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

Population: Pain-Relief-Response population. Subjects at 25th Quartile with pain progress during blinded phase.

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

Population: ITT population. Number of subjects analyzed = number of subjects with tumor response.