Gastrointestinal Stromal Tumor
Conditions
Brief summary
A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for approximately one year.
Detailed description
The study prematurely discontinued on July 27, 2009 due to poor recruitment and operational futility as a result of changes in clinical practice. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.
Interventions
DRUGsunitinib malate
37.5 mg daily
DRUGimatinib mesylate
800mg daily
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with gastrointestinal stromal tumors whose disease has progressed on imatinib 400 mg daily.
Exclusion criteria
* Current treatment with any chemotherapy other than imatinib. * Current treatment with any dose of imatinib other than 400 mg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Baseline, Week 5, and every 8 weeks until Year 2 | Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Pain Relief Response (TTPR) | Day 28 of Cycle 1 up to 26 | Pain relief response defined as a 50 percent (%) or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication. |
| Time to Treatment Failure (TTF) | Day 28 of Cycle 1 up to 26 | TTF included death for any reason, treatment termination due to intolerable toxicity, or withdrawal of consent, whichever occurred first. |
| Number of Participants With Objective Response of Complete Response or Partial Response | Day 28 of Cycle 1 up to 26 | Number of participants with objective response based assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. |
| Time to Tumor Response (TTR) | Day 28 of Cycle 1 up to 26 | Time from date of randomization to first documentation of objective tumor response (partial or complete response). Confirmed complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. |
| Duration of Response (DR) | Day 28 of Cycle 1 up to 26 | Time from start of first documentation of objective response(complete or partial response) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause, whichever occurred first. Confirmed complete response (CR) and partial response (PR)according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. |
| Time to Pain Progression (TTPP) | Day 28 of Cycle 1 up to 26 | TTPP is the number of days from randomization to the first documentation of pain progression (defined as a 50% or more increase in MPQ-PPI score \[0=no pain to 5=excruciating pain\] or analgesic use from baseline for at least 3 consecutive weeks). Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication. |
| Overall Survival (OS) | Baseline up to 2 years | Time from date of randomization to the date of death. In the absence of confirmation of death, survival time was censored to the last date the participant was known to be alive. |
| Number of Participants With Pain Progression | Day 28 of Cycle 1 up to 26 | Pain progression defined as a 50% or more increase in MPQ-PPI score (0=no pain to 5=excruciating pain) or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication. |
| Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm | Days 1 and 28 of each cycle | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigned utility value for each domain in profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state. |
| Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm | Days 1 and 28 of each cycle | EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state. |
| Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm | Days 1 and 28 of each cycle | EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigned utility value for each domain in the profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state. |
| Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm | Days 1 and 28 of each cycle | EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state. |
| Number of Participants With Pain Relief Response | Day 28 of Cycle 1 up to 26 | Pain relief response defined as a 50% or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication. |
Countries
Germany, Hong Kong, Italy, South Korea, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
12 participants were enrolled in a lead-in Phase 1 safety sub-study, all of whom received Sunitinib 37.5 milligram (mg) 24 hours after the last dose of imatinib. No efficacy evaluations were planned/conducted for this sub-study.
Participants by arm
| Arm | Count |
|---|---|
| Sunitinib (Phase 3) Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD. | 31 |
| Imatinib Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD. | 26 |
| Sunitinib (Phase 1) Single 37.5 mg dose administered 24 hours after the last dose of imatinib | 12 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Phase 3 Study | Adverse Event | 5 | 1 | 1 |
| Phase 3 Study | Death | 1 | 1 | 0 |
| Phase 3 Study | Global deterioration of health status | 0 | 1 | 0 |
| Phase 3 Study | Objective progression or relapse | 10 | 13 | 4 |
| Phase 3 Study | Other | 2 | 2 | 1 |
| Phase 3 Study | Protocol Violation | 0 | 0 | 1 |
| Phase 3 Study | study terminated by sponsor | 13 | 8 | 5 |
Baseline characteristics
| Characteristic | Total | Sunitinib (Phase 3) | Imatinib | Sunitinib (Phase 1) |
|---|---|---|---|---|
| Age, Customized greater than or equal to 65 years | 26 participants | 12 participants | 9 participants | 5 participants |
| Age, Customized less than 65 years | 43 participants | 19 participants | 17 participants | 7 participants |
| Sex: Female, Male Female | 27 Participants | 11 Participants | 11 Participants | 5 Participants |
| Sex: Female, Male Male | 42 Participants | 20 Participants | 15 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 43 / 43 | 23 / 25 |
| serious Total, serious adverse events | 11 / 43 | 5 / 25 |
Outcome results
Primary
Progression-Free Survival (PFS)
Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier.
Time frame: Baseline, Week 5, and every 8 weeks until Year 2
Population: Intention to treat (ITT): all participants in Main Study (Phase 3) who were randomized, regardless of whether the participant received any drug or received a different drug from that to which they were randomized. Number of participants analyzed: participants who had a PFS event (progressive disease or death).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Progression-Free Survival (PFS) | 8.6 Months |
| Imatinib | Progression-Free Survival (PFS) | 6.4 Months |
Comparison: No hypothesis tested.95% CI: [0.484, 2.235]Cox Proportional Hazards Model
Secondary
Duration of Response (DR)
Time from start of first documentation of objective response(complete or partial response) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause, whichever occurred first. Confirmed complete response (CR) and partial response (PR)according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time frame: Day 28 of Cycle 1 up to 26
Population: ITT; Number of participants analyzed: participants with an objective tumor response. DR data censored on the day following the date of the last tumor assessment on study for participants who did not have objective tumor progression and who did not die due to any cause while on study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Duration of Response (DR) | 18.3 Weeks |
| Imatinib | Duration of Response (DR) | 19.8 Weeks |
Secondary
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm
EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigned utility value for each domain in the profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state.
Time frame: Days 1 and 28 of each cycle
Population: ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm | Cycle 1 (n=22) | 0.80 Scores on a scale | Standard Deviation 0.117 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm | Cycle 2 (n=23) | 0.85 Scores on a scale | Standard Deviation 0.135 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm | Cycle 3 (n=18) | 0.82 Scores on a scale | Standard Deviation 0.162 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm | Cycle 4 (n=18) | 0.86 Scores on a scale | Standard Deviation 0.143 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm | Cycle 5 (n=17) | 0.83 Scores on a scale | Standard Deviation 0.217 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm | Cycle 6 (n=12) | 0.84 Scores on a scale | Standard Deviation 0.157 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm | Cycle 7 (n=12) | 0.81 Scores on a scale | Standard Deviation 0.26 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm | Cycle 8 ( (n=11) | 0.68 Scores on a scale | Standard Deviation 0.292 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm | Cycle 9 (n=7) | 0.86 Scores on a scale | Standard Deviation 0.105 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm | Cycle 10 (n=7) | 0.86 Scores on a scale | Standard Deviation 0.104 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm | Cycle 11 (n=3) | 0.88 Scores on a scale | Standard Deviation 0.106 |
Secondary
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigned utility value for each domain in profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state.
Time frame: Days 1 and 28 of each cycle
Population: ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm | Cycle 1 (n=30) | 0.90 Scores on a scale | Standard Deviation 0.159 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm | Cycle 2 (n=27) | 0.84 Scores on a scale | Standard Deviation 0.196 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm | Cycle 3 (n=21) | 0.84 Scores on a scale | Standard Deviation 0.13 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm | Cycle 4 (n=23) | 0.85 Scores on a scale | Standard Deviation 0.186 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm | Cycle 5 (n=16) | 0.89 Scores on a scale | Standard Deviation 0.133 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm | Cycle 6 (n=16) | 0.90 Scores on a scale | Standard Deviation 0.12 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm | Cycle 7 (n=12) | 0.84 Scores on a scale | Standard Deviation 0.182 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm | Cycle 8 (n=11) | 0.83 Scores on a scale | Standard Deviation 0.168 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm | Cycle 9 (n=6) | 0.76 Scores on a scale | Standard Deviation 0.149 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm | Cycle 10 (n=5) | 0.78 Scores on a scale | Standard Deviation 0.128 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm | Cycle 11 (n=3) | 0.83 Scores on a scale | Standard Deviation 0.157 |
| Sunitinib | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm | Cycle 12 (n=2) | 0.93 Scores on a scale | Standard Deviation 0.106 |
Secondary
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm
EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.
Time frame: Days 1 and 28 of each cycle
Population: ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm | Cycle 1 (n=22) | 75.41 Scores on a scale | Standard Deviation 16.6 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm | Cycle 2 (n=22) | 73.64 Scores on a scale | Standard Deviation 14.61 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm | Cycle 3 (n=20) | 72.85 Scores on a scale | Standard Deviation 15.24 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm | Cycle 4 (n=18) | 76.14 Scores on a scale | Standard Deviation 15.78 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm | Cycle 5 (n=15) | 68.93 Scores on a scale | Standard Deviation 12.82 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm | Cycle 6 (n=11) | 68.27 Scores on a scale | Standard Deviation 15.1 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm | Cycle 7 (n=12) | 67.08 Scores on a scale | Standard Deviation 18.08 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm | Cycle 8 (n=10) | 63.70 Scores on a scale | Standard Deviation 19.23 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm | Cycle 9 (n=7) | 74.64 Scores on a scale | Standard Deviation 13.26 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm | Cycle 10 (n=7) | 76.86 Scores on a scale | Standard Deviation 8.009 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm | Cycle 11 (n=3) | 75.33 Scores on a scale | Standard Deviation 5.508 |
Secondary
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm
EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.
Time frame: Days 1 and 28 of each cycle
Population: ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm | Cycle 1 (n=30) | 78.13 Scores on a Scale | Standard Deviation 23.8 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm | Cycle 2 (n=27) | 77.19 Scores on a Scale | Standard Deviation 19.98 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm | Cycle 3 (n=21) | 78.52 Scores on a Scale | Standard Deviation 14.24 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm | Cycle 4 (n=23) | 80.17 Scores on a Scale | Standard Deviation 14.28 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm | Cycle 5 (n=16) | 84.25 Scores on a Scale | Standard Deviation 12.3 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm | Cycle 6 (n=16) | 85.81 Scores on a Scale | Standard Deviation 13.25 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm | Cycle 7 (n=12) | 78.25 Scores on a Scale | Standard Deviation 15.91 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm | Cycle 8 (n=11) | 84.73 Scores on a Scale | Standard Deviation 12.71 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm | Cycle 9 (n=7) | 82.57 Scores on a Scale | Standard Deviation 14.3 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm | Cycle 10 (n=6) | 81.00 Scores on a Scale | Standard Deviation 12.59 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm | Cycle 11 (n=3) | 81.00 Scores on a Scale | Standard Deviation 14.93 |
| Sunitinib | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm | Cycle 12 (n=2) | 86.50 Scores on a Scale | Standard Deviation 16.26 |
Secondary
Number of Participants With Objective Response of Complete Response or Partial Response
Number of participants with objective response based assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time frame: Day 28 of Cycle 1 up to 26
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib | Number of Participants With Objective Response of Complete Response or Partial Response | 5 Participants |
| Imatinib | Number of Participants With Objective Response of Complete Response or Partial Response | 2 Participants |
95% CI: [0.4, 13]Cochran-Mantel-Haenszel
Secondary
Number of Participants With Pain Progression
Pain progression defined as a 50% or more increase in MPQ-PPI score (0=no pain to 5=excruciating pain) or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Time frame: Day 28 of Cycle 1 up to 26
Population: ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib | Number of Participants With Pain Progression | 14 Participants |
| Imatinib | Number of Participants With Pain Progression | 10 Participants |
95% CI: [0.5, 3.8]Cochran-Mantel-Haenszel
Secondary
Number of Participants With Pain Relief Response
Pain relief response defined as a 50% or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Time frame: Day 28 of Cycle 1 up to 26
Population: ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib | Number of Participants With Pain Relief Response | 2 Participants |
| Imatinib | Number of Participants With Pain Relief Response | 4 Participants |
95% CI: [0.1, 2.3]Cochran-Mantel-Haenszel
Secondary
Overall Survival (OS)
Time from date of randomization to the date of death. In the absence of confirmation of death, survival time was censored to the last date the participant was known to be alive.
Time frame: Baseline up to 2 years
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Overall Survival (OS) | 12.9 Months |
| Imatinib | Overall Survival (OS) | NA Months |
95% CI: [0.64, 12.41]Cox Proportional Hazards Model
Secondary
Time to Pain Progression (TTPP)
TTPP is the number of days from randomization to the first documentation of pain progression (defined as a 50% or more increase in MPQ-PPI score \[0=no pain to 5=excruciating pain\] or analgesic use from baseline for at least 3 consecutive weeks). Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Time frame: Day 28 of Cycle 1 up to 26
Population: ITT; Number of participants analyzed: participants with an event.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Time to Pain Progression (TTPP) | 22.0 Days |
| Imatinib | Time to Pain Progression (TTPP) | 99.0 Days |
95% CI: [1.057, 11.15]Cox Proportional Hazards Model
Secondary
Time to Pain Relief Response (TTPR)
Pain relief response defined as a 50 percent (%) or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Time frame: Day 28 of Cycle 1 up to 26
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Time to Pain Relief Response (TTPR) | 34.0 Days |
| Imatinib | Time to Pain Relief Response (TTPR) | 22.0 Days |
Secondary
Time to Treatment Failure (TTF)
TTF included death for any reason, treatment termination due to intolerable toxicity, or withdrawal of consent, whichever occurred first.
Time frame: Day 28 of Cycle 1 up to 26
Population: ITT; Number of participants analyzed: participants with treatment failure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Time to Treatment Failure (TTF) | 8.2 Months |
| Imatinib | Time to Treatment Failure (TTF) | 6.3 Months |
95% CI: [0.505, 2.088]Cox Proportional Hazards Model
Secondary
Time to Tumor Response (TTR)
Time from date of randomization to first documentation of objective tumor response (partial or complete response). Confirmed complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time frame: Day 28 of Cycle 1 up to 26
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Time to Tumor Response (TTR) | 4.1 Weeks |
| Imatinib | Time to Tumor Response (TTR) | 40.1 Weeks |