To evaluate the antitumor activity of SU011248 in advanced, imatinib mesylate-resistant gastrointestinal stromal tumor (GIST) when administered on a continuous daily dosing schedule
Subjects experiencing clinical benefit after 1 year on study were offered continued treatment with SU011248 on a separate protocol.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
37.5 mg once daily on a continuous daily dosing schedule. Study medication continued as long as patient was obtaining clinical benefit, or until significant toxicity, or withdrawal of consent, for up to 1 year on study.
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Lyon, France
Pfizer Investigational Site
Villejuif, France
Pfizer Investigational Site
Milan, Italy
Number of Participants With Clinical Benefit Response (CBR) According to RECIST
CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging \>= 4 wks after initial response. Participants with no on-study radiographic tumor re-evaluation counted as non-responders.
Time frame: Planned duration on this protocol of up to 1 year
Number of Participants by Best Confirmed Response Category According to RECIST
Best confirmed response (BCR) defined as best response \[confirmed CR, confirmed PR, SD, PD(progressive disease), not evaluable (NE)\] recorded from start of treatment until disease progression / recurrence. Best response of SD must have met SD criteria at least once after first dose at minimum interval of 6 weeks.
Time frame: Planned duration on this protocol of up to 1 year
Number of Participants With Overall Confirmed Objective Disease Response (ORR)
Overall confirmed objective disease response is defined as a confirmed CR, or confirmed PR according to RECIST. Confirmed responses are those that persisted on repeat imaging \>= 4 wks after initial response.
Time frame: Planned duration on this protocol of up to 1 year
Duration of Stable Disease
Duration of SD is the time from the date of first documentation of stable disease to the date of first documentation of objective tumor progression or death due to any cause that occurred within 28 days after last dose of study medication, whichever occurred first.
Time frame: Planned duration on this protocol of up to 1 year
Progression-free Survival (PFS)
PFS was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression or to death due to any cause that occurred on treatment including within 28 days after the last dose of study medication, whichever occurred first.
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Time frame: Planned duration on this protocol of up to 1 year
Time to Tumor Progression (TTP)
TTP was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression that occurred on treatment including within 28 days after the last dose of study medication.
Time frame: Planned duration on this protocol of up to 1 year
Duration of Tumor Response (DR) [Descriptive Statistics]
DR was defined as the time from the date of first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the date of the first documentation of objective tumor progression or to death due to any cause that occurred within 28 days after the last dose of study medication, whichever occurred first.
Time frame: Planned duration on this protocol of up to 1 year
Overall Survival (OS) and One-year Survival [Descriptive Statistics]
Overall survival is defined as time from the date of first dose of study medication to the date of death due to any cause. One year survival rate defined as the probability that a patient is alive 1 year after the date of first study medication.
Time frame: Survival status was collected by telephone contact every 2 months for up to 2 years from study entry.
Score of FACIT-Fatigue Scale
FACIT-Fatigue Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Maximum, minimum mean included data available for \>=10 subjects.
Time frame: Baseline, Day 1 & 15 of each treatment cycle
Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale)
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. Change: median score at observation minus median score at baseline. Maximum changes (Increase or Decrease from baseline) included data available for \>=10 subjects.
Time frame: Baseline, Day 1 &15 of each treatment cycle up to 1 year on study
Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index
EQ-5D: 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 0.0 = death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline (includes data available for \>=10 subjects).
Time frame: Baseline, Day 1 & 15 of each treatment cycle up to 1 year on study