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This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel and prednisone for the first-line treatment of metastatic hormone-refractory prostate cancer (mHRPC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | SU011248 in combination with docetaxel and prednisone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel Phase 1 - escalating doses (60 and 75 mg/m2), intravenous therapy (IV), administered every 3 weeks. Phase 2 - Phase 1 optimal combination dose (75 mg/m2, IV, every 3 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Prostate Specific Antigen (PSA) Response | PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed. | Baseline, Day 1 of each 21-day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Time to PSA Progression | Defined as the time from start of study treatment to first documentation of PSA progression using the PSA Working Group criteria calculated as (first event date - first dose date + 1)/7. PSA progression is defined for patients with a PSA response, as a 50% increase over nadir (lowest) and increase in absolute-value PSA level by at least 5 nanograms per milliliter (ng/mL) [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir (lowest)] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Harvey | Illinois | 60426 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Once the Optimal Combination Dose of SU011248, Docetaxel, and prednisone was determined in Phase 1, the study proceeded to Phase 2. There were 38 participants in Phase 1; those participants did not continue into Phase 2. Per FDAAA, only Phase 2 data are posted; timeframes are relative to Phase 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg | Sunitinib 37.5 milligrams (mg) plus (+) Docetaxel 75 mg per meters squared (mg/m^2) + Prednisone 5 mg given twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Prednisone | Drug | Prednisone Phase1/2 - 5 mg twice a day (BID), oral. |
|
| SU011248 | Drug | SU011248 Phase 1 - escalating doses (12.5, 37.5, and 50 mg), oral, administered on a 2-weeks on, 1-week off daily regimen (Schedule 2/1). Phase 2 - Phase 1 optimal combination dose (37.5 mg/day, oral, Schedule 2/1). |
|
| Baseline to first documentation of PSA progression up to 28 days after date of last dose |
| Duration of PSA Response (DPR) | Defined as time from first documentation of PSA response (≥50% decrease in PSA from baseline that is subsequently confirmed) to first documentation of PSA progression (defined for patients with a PSA response as a 50% increase over nadir [lowest] and increase in absolute-value PSA level by at least 5 ng/mL [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir / lowest] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value). Calculated as (end date for DPR - first PSA response + 1)/7. | Baseline to first documentation of PSA progression up to 28 days after date of last dose |
| Percentage of Participants With Objective Response Rate (ORR) | Defined as confirmed complete response (CR: disappearance of all target lesions) or confirmed partial response (PR: ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response. | Baseline to first documentation of PSA progression up to 28 days after date of last dose |
| Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC | Soluble protein biomarker Vascular Endothelial Growth Factor C (VEGFC) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1). | Baseline (Cycle 1 Day 1 [C1.D1]), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14 |
| Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2 | Soluble protein biomarker Vascular Endothelial Growth Factor receptor 2 (VEGFR2) measured as pg/mL. PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1). | Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14 |
| Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3 | Soluble protein biomarker Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1). | Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14 |
| Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC | Soluble protein biomarker VEGFC measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months. | Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14 |
| Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2 | Soluble protein biomarker VEGFR2 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months. | Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14 |
| Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3 | Soluble protein biomarker VEGFR3 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months. | Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14 |
| Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) | The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain intensity index score was derived from Questions 2-5 with range from 0 to 10 (0: no pain; 1-4: mild pain; 5-6: moderate pain; 7-10: severe pain); higher scores indicate worse health status. | Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study) |
| Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) | The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain interference index score (to measure how much pain had interfered with daily activities) was derived from Questions 7A-7G with a range from 0 (no interference) to 10 (completely interferes); higher scores indicate more interference. | Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study) |
| Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) | Assesses health related quality of life and advanced prostate cancer specific symptoms. FACT-General (FACT-G) assesses 4 domains: physical, social and family, emotional, and functional well-being. The prostate cancer subscale assesses prostate cancer symptoms focusing on pain, urination problems, and sexual functions. Individual scores range from 0 (not at all) to 4 (very much). Scores for some of the individual questions are reverse-coded in order for higher scores to correspond to better health status. FACT-P overall score range is 0 to 156; higher scores indicate better health status. | Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study) |
| Preliminary Assessment of PSA Modulation by SU011248 | PSA modulation analyzed by the mean change in PSA response measured as ng/mL. | Baseline to Day 28 |
| Tinley Park |
| Illinois |
| 60477 |
| United States |
| Pfizer Investigational Site | Hobart | Indiana | 46342 | United States |
| Pfizer Investigational Site | Munster | Indiana | 46321 | United States |
| Pfizer Investigational Site | Durham | North Carolina | 27710 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97239-3098 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97239 | United States |
| Pfizer Investigational Site | Myrtle Beach | South Carolina | 29572 | United States |
| Pfizer Investigational Site | Clarksville | Tennessee | 37043 | United States |
| Pfizer Investigational Site | Franklin | Tennessee | 37067 | United States |
| Pfizer Investigational Site | Gallarin | Tennessee | 37066 | United States |
| Pfizer Investigational Site | Hermitage | Tennessee | 37076 | United States |
| Pfizer Investigational Site | Lebanon | Tennessee | 37087 | United States |
| Pfizer Investigational Site | Murfreesboro | Tennessee | 37130 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37203 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37205 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37207 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37211 | United States |
| Pfizer Investigational Site | Smithville | Tennessee | 37166 | United States |
| Pfizer Investigational Site | Smyrna | Tennessee | 37167 | United States |
| Pfizer Investigational Site | Tullahoma | Tennessee | 37388 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75246 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | Madison | Wisconsin | 53792 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg | SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Prostate Specific Antigen (PSA) Response | PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed. | The intent-to-treat (ITT) population was defined as all patients enrolled in the study that receive at least 1 dose of study medication (SU011248 or docetaxel) | Posted | Median | 95% Confidence Interval | percentage of participants | Baseline, Day 1 of each 21-day cycle |
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| Secondary | Time to PSA Progression | Defined as the time from start of study treatment to first documentation of PSA progression using the PSA Working Group criteria calculated as (first event date - first dose date + 1)/7. PSA progression is defined for patients with a PSA response, as a 50% increase over nadir (lowest) and increase in absolute-value PSA level by at least 5 nanograms per milliliter (ng/mL) [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir (lowest)] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value. | ITT | Posted | Median | Full Range | weeks | Baseline to first documentation of PSA progression up to 28 days after date of last dose |
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| Secondary | Duration of PSA Response (DPR) | Defined as time from first documentation of PSA response (≥50% decrease in PSA from baseline that is subsequently confirmed) to first documentation of PSA progression (defined for patients with a PSA response as a 50% increase over nadir [lowest] and increase in absolute-value PSA level by at least 5 ng/mL [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir / lowest] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value). Calculated as (end date for DPR - first PSA response + 1)/7. | ITT; DPR only calculated for the subgroup of patients with PSA response rate. | Posted | Median | Full Range | weeks | Baseline to first documentation of PSA progression up to 28 days after date of last dose |
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| Secondary | Percentage of Participants With Objective Response Rate (ORR) | Defined as confirmed complete response (CR: disappearance of all target lesions) or confirmed partial response (PR: ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response. | ITT; N=participants with measurable disease at baseline, received at least 1 dose of study medication, and had correct histological cancer type. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to first documentation of PSA progression up to 28 days after date of last dose |
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| Secondary | Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC | Soluble protein biomarker Vascular Endothelial Growth Factor C (VEGFC) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1). | ITT | Posted | Median | Full Range | pg/mL | Baseline (Cycle 1 Day 1 [C1.D1]), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14 |
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| Secondary | Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2 | Soluble protein biomarker Vascular Endothelial Growth Factor receptor 2 (VEGFR2) measured as pg/mL. PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1). | ITT | Posted | Median | Full Range | pg/mL | Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14 |
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| Secondary | Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3 | Soluble protein biomarker Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1). | ITT | Posted | Median | Full Range | pg/mL | Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14 |
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| Secondary | Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC | Soluble protein biomarker VEGFC measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months. | ITT | Posted | Median | Full Range | pg/mL | Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14 |
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| Secondary | Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2 | Soluble protein biomarker VEGFR2 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months. | ITT | Posted | Median | Full Range | pg/mL | Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14 |
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| Secondary | Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3 | Soluble protein biomarker VEGFR3 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months. | ITT | Posted | Median | Full Range | pg/mL | Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14 |
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| Secondary | Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) | The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain intensity index score was derived from Questions 2-5 with range from 0 to 10 (0: no pain; 1-4: mild pain; 5-6: moderate pain; 7-10: severe pain); higher scores indicate worse health status. | Patient reported outcomes (PRO) evaluable population defined as participants in the ITT population who received at least 1 dose of study medication (sunitinib or docetaxel) and had baseline data; (n)=number of participants with evaluable data at observation. | Posted | Mean | 95% Confidence Interval | scores on a scale | Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study) |
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| Secondary | Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) | The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain interference index score (to measure how much pain had interfered with daily activities) was derived from Questions 7A-7G with a range from 0 (no interference) to 10 (completely interferes); higher scores indicate more interference. | PRO evaluable population; (n)=number of participants with evaluable data at observation. | Posted | Mean | 95% Confidence Interval | scores on a scale | Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study) |
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| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) | Assesses health related quality of life and advanced prostate cancer specific symptoms. FACT-General (FACT-G) assesses 4 domains: physical, social and family, emotional, and functional well-being. The prostate cancer subscale assesses prostate cancer symptoms focusing on pain, urination problems, and sexual functions. Individual scores range from 0 (not at all) to 4 (very much). Scores for some of the individual questions are reverse-coded in order for higher scores to correspond to better health status. FACT-P overall score range is 0 to 156; higher scores indicate better health status. | PRO evaluable population; (n)=number of participants with evaluable data at observation. | Posted | Mean | 95% Confidence Interval | scores on a scale | Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study) |
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| Secondary | Preliminary Assessment of PSA Modulation by SU011248 | PSA modulation analyzed by the mean change in PSA response measured as ng/mL. | ITT population; PSA modulation was listed as a secondary endpoint for Phase 2, however, modulation was planned for analysis only for Phase 1 portion of the study. No formal analysis was completed to determine modulation. | Posted | Mean | 95% Confidence Interval | ng/mL | Baseline to Day 28 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg | SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily | 28 | 55 | 55 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
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| Arrhythmia supraventricular | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Oesophagitis haemorrhagic | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Chills | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Multi-organ failure | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Cholestasis | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Perirectal abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Pseudomonas infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Skin depigmentation | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Sinus operation | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
Per FDAAA, only the Phase 2 study results are posted.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Clinical Trials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000077210 | Sunitinib |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
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