Gastrointestinal Stromal Tumors
Conditions
Brief summary
To evaluate the antitumor activity of SU011248 in advanced, imatinib mesylate-resistant gastrointestinal stromal tumor (GIST) when administered on a continuous daily dosing schedule
Detailed description
Subjects experiencing clinical benefit after 1 year on study were offered continued treatment with SU011248 on a separate protocol.
Interventions
DRUGSU011248
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.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histopathologically proven diagnosis of malignant GIST that was not amenable to standard therapy. * Failed prior treatment with imatinib mesylate, defined either by progression of disease (according to Response Evaluation Criterion in Solid Tumors (RECIST) or World Health Organization (WHO) criteria), or by significant toxicity during treatment with imatinib mesylate that precluded further treatment. Intolerance to prior imatinib mesylate therapy was defined as follows: * Life-threatening adverse events (ie, Grade 4) at any dose (attempt to dose reduce or rechallenge not required) or Unacceptable toxicity induced by a moderate dose (eg, 400 mg/day), specifically, Grade 2 toxicity that was unacceptable to the patient (such as nausea) that persisted despite standard countermeasures * Evidence of unidimensionally measurable disease.
Exclusion criteria
* Previous treatment on a SU011248 clinical trial. * Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma, that had been adequately treated with no evidence of recurrent disease for 12 months. * History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. * Any of the following within the 12 months prior to starting the study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. * Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc interval \>450 msec for males or \>470 msec for females. * Hypertension that could not be controlled by medications (\>150/100 mm/Hg despite optimal medical therapy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Benefit Response (CBR) According to RECIST | Planned duration on this protocol of up to 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Overall Confirmed Objective Disease Response (ORR) | Planned duration on this protocol of up to 1 year | 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. |
| Duration of Stable Disease | Planned duration on this protocol of up to 1 year | 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. |
| Progression-free Survival (PFS) | Planned duration on this protocol of up to 1 year | 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. |
| Time to Tumor Progression (TTP) | Planned duration on this protocol of up to 1 year | 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. |
| Number of Participants by Best Confirmed Response Category According to RECIST | Planned duration on this protocol of up to 1 year | 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. |
| Overall Survival (OS) and One-year Survival [Descriptive Statistics] | Survival status was collected by telephone contact every 2 months for up to 2 years from study entry. | 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. |
| Score of FACIT-Fatigue Scale | Baseline, Day 1 & 15 of each treatment cycle | 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. |
| Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale) | Baseline, Day 1 &15 of each treatment cycle up to 1 year on study | 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. |
| Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index | Baseline, Day 1 & 15 of each treatment cycle up to 1 year on study | 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). |
| Duration of Tumor Response (DR) [Descriptive Statistics] | Planned duration on this protocol of up to 1 year | 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. |
Countries
France, Italy, United States
Participant flow
Pre-assignment details
Must have failed prior treatment with imatinib mesylate (IM) \[defined as progression of disease using Response Evaluation Criteria in Solid Tumors(RECIST) or World Health Organization(WHO) criteria, or significant toxicity during treatment with IM precluding further treatment & Eastern Cooperative Oncology Group(ECOG) performance status of 0-1\]
Participants by arm
| Arm | Count |
|---|---|
| AM Dose Sunitinib Malate Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily. | 30 |
| PM Dose Sunitinib Malate Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Death | 4 | 3 |
| Overall Study | Disease Progression | 8 | 13 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | AM Dose Sunitinib Malate | PM Dose Sunitinib Malate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical >=65 years | 13 Participants | 12 Participants | 25.0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 18 Participants | 35.0 Participants |
| Age Continuous | 59.3 years STANDARD_DEVIATION 14.5 | 57.0 years STANDARD_DEVIATION 14.8 | 58.2 years STANDARD_DEVIATION 14.6 |
| Sex: Female, Male Female | 15 Participants | 17 Participants | 32.0 Participants |
| Sex: Female, Male Male | 15 Participants | 13 Participants | 28.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / — | 30 / — |
| serious Total, serious adverse events | 13 / — | 12 / — |
Outcome results
Primary
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
Population: ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. CR+PR+(SD for \>=24 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AM Dose Sunitinib Malate | Number of Participants With Clinical Benefit Response (CBR) According to RECIST | 15 participants |
| PM Dose Sunitinib Malate | Number of Participants With Clinical Benefit Response (CBR) According to RECIST | 17 participants |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Number of Participants With Clinical Benefit Response (CBR) According to RECIST | 32 participants |
95% CI: [31.3, 68.7]F distribution
95% CI: [37.4, 74.5]F distribution
Comparison: Null hypothesis that the true CBR \<=20% vs the alternative hypothesis that the true clinical benefit rate is at least 35%. The sample size is determined using a single-stage design with an alpha level of 10% \& 90% power. If \>=17 CR, PR or SD for at least 24 weeks are observed, null hypothesis can be rejected with a 20% target false positive error rate. If \<= 16 CR, PR,or SD for at least 24 weeks are observed, null hypothesis can not be rejected with a target false negative error rate of 10%.95% CI: [40, 66.3]F distribution
Secondary
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
Population: ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AM Dose Sunitinib Malate | Duration of Stable Disease | >= 12 weeks | 19 Participants |
| AM Dose Sunitinib Malate | Duration of Stable Disease | >= 24 weeks | 12 Participants |
| PM Dose Sunitinib Malate | Duration of Stable Disease | >= 12 weeks | 14 Participants |
| PM Dose Sunitinib Malate | Duration of Stable Disease | >= 24 weeks | 12 Participants |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Duration of Stable Disease | >= 12 weeks | 33 Participants |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Duration of Stable Disease | >= 24 weeks | 24 Participants |
Secondary
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
Population: ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. Number of responders (AM=3, PM=5, Total=8)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AM Dose Sunitinib Malate | Duration of Tumor Response (DR) [Descriptive Statistics] | 32.7 weeks |
| PM Dose Sunitinib Malate | Duration of Tumor Response (DR) [Descriptive Statistics] | 40.3 weeks |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Duration of Tumor Response (DR) [Descriptive Statistics] | 33.9 weeks |
Secondary
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
Population: ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AM Dose Sunitinib Malate | Number of Participants by Best Confirmed Response Category According to RECIST | Progressive disease (PD) | 2 participants |
| AM Dose Sunitinib Malate | Number of Participants by Best Confirmed Response Category According to RECIST | Stable Disease (SD) | 20 participants |
| AM Dose Sunitinib Malate | Number of Participants by Best Confirmed Response Category According to RECIST | Complete Response (CR) | 0 participants |
| AM Dose Sunitinib Malate | Number of Participants by Best Confirmed Response Category According to RECIST | Partial Response (PR) | 3 participants |
| AM Dose Sunitinib Malate | Number of Participants by Best Confirmed Response Category According to RECIST | Not evaluable (NE) | 5 participants |
| PM Dose Sunitinib Malate | Number of Participants by Best Confirmed Response Category According to RECIST | Stable Disease (SD) | 20 participants |
| PM Dose Sunitinib Malate | Number of Participants by Best Confirmed Response Category According to RECIST | Complete Response (CR) | 0 participants |
| PM Dose Sunitinib Malate | Number of Participants by Best Confirmed Response Category According to RECIST | Partial Response (PR) | 5 participants |
| PM Dose Sunitinib Malate | Number of Participants by Best Confirmed Response Category According to RECIST | Progressive disease (PD) | 4 participants |
| PM Dose Sunitinib Malate | Number of Participants by Best Confirmed Response Category According to RECIST | Not evaluable (NE) | 1 participants |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Number of Participants by Best Confirmed Response Category According to RECIST | Not evaluable (NE) | 6 participants |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Number of Participants by Best Confirmed Response Category According to RECIST | Progressive disease (PD) | 6 participants |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Number of Participants by Best Confirmed Response Category According to RECIST | Complete Response (CR) | 0 participants |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Number of Participants by Best Confirmed Response Category According to RECIST | Stable Disease (SD) | 40 participants |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Number of Participants by Best Confirmed Response Category According to RECIST | Partial Response (PR) | 8 participants |
Secondary
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
Population: ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AM Dose Sunitinib Malate | Number of Participants With Overall Confirmed Objective Disease Response (ORR) | 3 participants |
| PM Dose Sunitinib Malate | Number of Participants With Overall Confirmed Objective Disease Response (ORR) | 5 participants |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Number of Participants With Overall Confirmed Objective Disease Response (ORR) | 8 participants |
95% CI: [2.1, 26.5]F distribution
95% CI: [5.6, 34.7]F distribution
95% CI: [5.9, 24.6]F distribution
Secondary
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.
Population: ITT population (all subjects enrolled that received at least 1 dose of study medication).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AM Dose Sunitinib Malate | Overall Survival (OS) and One-year Survival [Descriptive Statistics] | Number of subjects alive | 16 participants |
| AM Dose Sunitinib Malate | Overall Survival (OS) and One-year Survival [Descriptive Statistics] | Number of subjects dead | 14 participants |
| PM Dose Sunitinib Malate | Overall Survival (OS) and One-year Survival [Descriptive Statistics] | Number of subjects alive | 17 participants |
| PM Dose Sunitinib Malate | Overall Survival (OS) and One-year Survival [Descriptive Statistics] | Number of subjects dead | 13 participants |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Overall Survival (OS) and One-year Survival [Descriptive Statistics] | Number of subjects alive | 33 participants |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Overall Survival (OS) and One-year Survival [Descriptive Statistics] | Number of subjects dead | 27 participants |
95% CI: [40.5, 75]Kaplan-Meier method
95% CI: [60.3, 90.3]Kaplan-Meier method
95% CI: [56.3, 79.7]Kaplan-Meier method
Secondary
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.
Time frame: Planned duration on this protocol of up to 1 year
Population: ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AM Dose Sunitinib Malate | Progression-free Survival (PFS) | Patient was censored | 12 participants |
| AM Dose Sunitinib Malate | Progression-free Survival (PFS) | Patient observed to have an event | 18 participants |
| PM Dose Sunitinib Malate | Progression-free Survival (PFS) | Patient was censored | 10 participants |
| PM Dose Sunitinib Malate | Progression-free Survival (PFS) | Patient observed to have an event | 20 participants |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Progression-free Survival (PFS) | Patient was censored | 22 participants |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Progression-free Survival (PFS) | Patient observed to have an event | 38 participants |
Comparison: 95% CI calculated based on the method of Brookmeyer and Crowley. Median reported is progression free survival weeks.95% CI: [22, 73.1]Kaplan-Meier method
Comparison: 95% CI calculated based on the method of Brookmeyer and Crowley.Median reported is progression free survival weeks.95% CI: [24.4, 51.6]Kaplan-Meier method
Comparison: 95% CI calculated based on the method of Brookmeyer and Crowley.Median reported is progression free survival weeks.95% CI: [24.1, 49]Kaplan-Meier method
Secondary
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
Population: ITT population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AM Dose Sunitinib Malate | Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index | Maximum Increase | 0.1 score on scale |
| AM Dose Sunitinib Malate | Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index | Maximum Decrease | -0.1 score on scale |
| PM Dose Sunitinib Malate | Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index | Maximum Increase | 0.0 score on scale |
| PM Dose Sunitinib Malate | Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index | Maximum Decrease | -0.8 score on scale |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index | Maximum Increase | 0.1 score on scale |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index | Maximum Decrease | -0.1 score on scale |
Secondary
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
Population: ITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AM Dose Sunitinib Malate | Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale) | Maximum Increase | 7.5 score on scale |
| AM Dose Sunitinib Malate | Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale) | Maximum Decrease | 0.0 score on scale |
| PM Dose Sunitinib Malate | Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale) | Maximum Increase | 10.0 score on scale |
| PM Dose Sunitinib Malate | Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale) | Maximum Decrease | -10.0 score on scale |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale) | Maximum Increase | 18.0 score on scale |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale) | Maximum Decrease | -7.5 score on scale |
Secondary
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
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AM Dose Sunitinib Malate | Score of FACIT-Fatigue Scale | Maximum Post-Baseline Score | 40.6 score on scale | Standard Deviation 10.38 |
| AM Dose Sunitinib Malate | Score of FACIT-Fatigue Scale | Baseline Score | 35.9 score on scale | Standard Deviation 11.13 |
| AM Dose Sunitinib Malate | Score of FACIT-Fatigue Scale | Minimum Post-Baseline Score | 26.9 score on scale | Standard Deviation 12.39 |
| PM Dose Sunitinib Malate | Score of FACIT-Fatigue Scale | Maximum Post-Baseline Score | 42.8 score on scale | Standard Deviation 8.61 |
| PM Dose Sunitinib Malate | Score of FACIT-Fatigue Scale | Baseline Score | 36.3 score on scale | Standard Deviation 13.69 |
| PM Dose Sunitinib Malate | Score of FACIT-Fatigue Scale | Minimum Post-Baseline Score | 26.0 score on scale | Standard Deviation 13.87 |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Score of FACIT-Fatigue Scale | Baseline Score | 36.1 score on scale | Standard Deviation 12.35 |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Score of FACIT-Fatigue Scale | Minimum Post-Baseline Score | 26.4 score on scale | Standard Deviation 13.06 |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Score of FACIT-Fatigue Scale | Maximum Post-Baseline Score | 41.7 score on scale | Standard Deviation 9.5 |
Secondary
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
Population: ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AM Dose Sunitinib Malate | Time to Tumor Progression (TTP) | Patient observed to have an event | 12 participants |
| AM Dose Sunitinib Malate | Time to Tumor Progression (TTP) | Patient was censored | 18 participants |
| PM Dose Sunitinib Malate | Time to Tumor Progression (TTP) | Patient observed to have an event | 17 participants |
| PM Dose Sunitinib Malate | Time to Tumor Progression (TTP) | Patient was censored | 13 participants |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Time to Tumor Progression (TTP) | Patient was censored | 31 participants |
| Total (Equals AM Plus PM Dose) Sunitinib Malate | Time to Tumor Progression (TTP) | Patient observed to have an event | 29 participants |
Comparison: 95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.95% CI: [24.1, 73.1]Kaplan-Meier method
Comparison: 95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.95% CI: [26.1, 65.9]Kaplan-Meier method
Comparison: 95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.95% CI: [26.1, 65.9]Kaplan-Meier method