A Phase 1/2 interventional study of Docetaxel and Prednisone in Prostatic Neoplasms, sponsored by Pfizer. Completed at 24 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-29.
Sponsored by Pfizer · Phase 1/2, Interventional, and Treatment
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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This study's enrollment of 93 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
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Exclusion Criteria:
SU011248 in combination with docetaxel and prednisone
Drug: Docetaxel · Drug: Prednisone · Drug: SU011248
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).
Also known as: Taxotere; Sunitinib malate; SUTENT
Prednisone Phase1/2 - 5 mg twice a day (BID), oral.
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).
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.
Time frame: Baseline, Day 1 of each 21-day cycle
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Day 28
| Milestone | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Started | 55 |
| Completed | 12 |
| Not completed | 43 |
| Withdrew: Adverse event | 13 |
| Withdrew: Death | 2 |
| Withdrew: Lack of efficacy | 17 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Other | 5 |
PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed.
| percentage of participants | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Percentage of Participants With Prostate Specific Antigen (PSA) Response | 56.4 (42.3 to 69.7) |
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.
| weeks | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Time to PSA Progression | 42.1 (33.1 to NA) |
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.
| weeks | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Duration of PSA Response (DPR) | 39.1 (36.0 to NA) |
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.
| percentage of participants | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Percentage of Participants With Objective Response Rate (ORR) | 42.4 (25.5 to 60.8) |
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).
| pg/mL | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Bsl median - PSA responder | 622.70 (NA to NA) |
| Bsl median - PSA non-responder | 639.70 (NA to NA) |
| C1D14 : C1D1 - PSA responder | 1.06 (NA to NA) |
| C1D14 : C1D1 - PSA non-responder | 1.07 (NA to NA) |
| C2.D1 : C1D1 - PSA responder | 0.88 (NA to NA) |
| C2.D1 : C1D1 - PSA non-responder | 0.93 (NA to NA) |
| C2.D14 : C1D1 - PSA responder | 0.92 (NA to NA) |
| C2.D14 : C1D1 - PSA non-responder | 0.95 (NA to NA) |
| C3.D1 : C1D1 - PSA responder | 1.51 (NA to NA) |
| C3.D14 : C1D1 - PSA responder | 0.97 (NA to NA) |
| C3.D14 : C1D1 - PSA non-responder | 0.96 (NA to NA) |
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).
| pg/mL | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Bsl median - PSA responder | 9889.00 (NA to NA) |
| Bsl median - PSA non-responder | 10324.00 (NA to NA) |
| C1D14 : C1D1 - PSA responder | 0.73 (NA to NA) |
| C1D14 : C1D1 - PSA non-responder | 0.68 (NA to NA) |
| C2.D1 : C1D1 - PSA responder | 0.80 (NA to NA) |
| C2.D1 : C1D1 - PSA non-responder | 0.79 (NA to NA) |
| C2.D14 : C1D1 - PSA responder | 0.67 (NA to NA) |
| C2.D14 : C1D1 - PSA non-responder | 0.60 (NA to NA) |
| C3.D1 : C1D1 - PSA responder | 0.81 (NA to NA) |
| C3.D14 : C1D1 - PSA responder | 0.63 (NA to NA) |
| C3.D14 : C1D1 - PSA non-responder | 0.67 (NA to NA) |
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).
| pg/mL | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Bsl median - PSA responder | 22475.00 (NA to NA) |
| Bsl median - PSA non-responder | 22070.00 (NA to NA) |
| C1D14 : C1D1 - PSA responder | 0.69 (NA to NA) |
| C1D14 : C1D1 - PSA non-responder | 0.73 (NA to NA) |
| C2.D1 : C1D1 - PSA responder | 0.75 (NA to NA) |
| C2.D1 : C1D1 - PSA non-responder | 0.75 (NA to NA) |
| C2.D14 : C1D1 - PSA responder | 0.65 (NA to NA) |
| C2.D14 : C1D1 - PSA non-responder | 0.72 (NA to NA) |
| C3.D1 : C1D1 - PSA responder | 0.65 (NA to NA) |
| C3.D14 : C1D1 - PSA responder | 0.56 (NA to NA) |
| C3.D14 : C1D1 - PSA non-responder | 0.66 (NA to NA) |
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.
| pg/mL | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Bsl median - CR or PR | 581.05 (NA to NA) |
| Bsl median - SD or PD | 586.85 (NA to NA) |
| C1D14 : C1D1 - CR or PR | 1.21 (NA to NA) |
| C1D14 : C1D1 - SD or PD | 1.19 (NA to NA) |
| C2.D1 : C1D1 - CR or PR | 0.89 (NA to NA) |
| C2.D1 : C1D1 - SD or PD | 1.15 (NA to NA) |
| C2.D14 : C1D1 - CR or PR | 0.92 (NA to NA) |
| C2.D14 : C1D1 - SD or PD | 0.97 (NA to NA) |
| C3.D14 : C1D1 - CR or PR | 0.88 (NA to NA) |
| C3.D14 : C1D1 - SD or PD | 0.59 (NA to NA) |
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.
| pg/mL | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Bsl median - CR or PR | 9837.50 (NA to NA) |
| Bsl median - SD or PD | 9484.25 (NA to NA) |
| C1D14 : C1D1 - CR or PR | 0.73 (NA to NA) |
| C1D14 : C1D1 - SD or PD | 0.75 (NA to NA) |
| C2.D1 : C1D1 - CR or PR | 0.83 (NA to NA) |
| C2.D1 : C1D1 - SD or PD | 0.83 (NA to NA) |
| C2.D14 : C1D1 - CR or PR | 0.68 (NA to NA) |
| C2.D14 : C1D1 - SD or PD | 0.60 (NA to NA) |
| C3.D14 : C1D1 - CR or PR | 0.63 (NA to NA) |
| C3.D14 : C1D1 - SD or PD | 0.80 (NA to NA) |
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.
| pg/mL | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Bsl median - CR or PR | 19975.00 (NA to NA) |
| Bsl median - SD or PD | 22495.00 (NA to NA) |
| C1D14 : C1D1 - CR or PR | 0.72 (NA to NA) |
| C1D14 : C1D1 - SD or PD | 0.68 (NA to NA) |
| C2.D1 : C1D1 - CR or PR | 0.78 (NA to NA) |
| C2.D1 : C1D1 - SD or PD | 0.83 (NA to NA) |
| C2.D14 : C1D1 - CR or PR | 0.69 (NA to NA) |
| C2.D14 : C1D1 - SD or PD | 0.80 (NA to NA) |
| C3.D14 : C1D1 - CR or PR | 0.61 (NA to NA) |
| C3.D14 : C1D1 - SD or PD | 0.78 (NA to NA) |
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.
| scores on a scale | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Bsl mean C1.D1 (n=48) | 1.9 (1.4 to 2.4) |
| Change from Bsl - C2.D1 (n=42) | -1.0 (-1.4 to -0.5) |
| Change from Bsl - C3.D1 (n=35) | -1.1 (-1.7 to -0.5) |
| Change from Bsl - C4.D1 (n=30) | -0.8 (-1.7 to 0.0) |
| Change from Bsl - C5.D1 (n=32) | -0.8 (-1.7 to 0.1) |
| Change from Bsl - C6.D1 (n=32) | -0.8 (-1.6 to 0.0) |
| Change from Bsl - C7.D1 (n=29) | -0.8 (-1.6 to -0.1) |
| Change from Bsl - C8.D1 (n=26) | -0.7 (-1.7 to 0.3) |
| Change from Bsl - C9.D1 (n=25) | -0.5 (-1.3 to 0.4) |
| Change from Bsl - C10.D1 (n=22) | -0.7 (-1.5 to 0.0) |
| Change from Bsl - C11.D1 (n=21) | -1.2 (-2.0 to -0.5) |
| Change from Bsl - C12.D1 (n=18) | -0.8 (-1.8 to 0.1) |
| Change from Bsl - C13.D1 (n=17) | -1.2 (-2.1 to -0.3) |
| Change from Bsl - C14.D1 (n=17) | -1.3 (-2.1 to -0.6) |
| Change from Bsl - C15.D1 (n=12) | -1.1 (-2.2 to 0.1) |
| Change from Bsl - C16.D1 (n=12) | -0.5 (-2.6 to 1.6) |
| Change from Bsl - EOT (n=37) | -0.3 (-1.0 to 0.3) |
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.
| scores on a scale | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Bsl mean C1.D1 (n=48) | 1.8 (1.2 to 2.4) |
| Change from Bsl - C2.D1 (n=41) | -0.7 (-1.1 to -0.3) |
| Change from Bsl - C3.D1 (n=34) | -0.8 (-1.5 to -0.2) |
| Change from Bsl - C4.D1 (n=30) | -0.5 (-1.4 to 0.5) |
| Change from Bsl - C5.D1 (n=31) | -0.7 (-1.8 to 0.4) |
| Change from Bsl - C6.D1 (n=32) | -0.6 (-1.4 to 0.3) |
| Change from Bsl - C7.D1 (n=29) | -0.4 (-1.1 to 0.4) |
| Change from Bsl - C8.D1 (n=26) | -0.5 (-1.3 to 0.3) |
| Change from Bsl - C9.D1 (n=24) | -0.5 (-1.3 to 0.3) |
| Change from Bsl - C10.D1 (n=21) | -0.4 (-1.3 to 0.5) |
| Change from Bsl - C11.D1 (n=21) | -0.7 (-1.7 to 0.3) |
| Change from Bsl - C12.D1 (n=18) | -0.8 (-2.0 to 0.4) |
| Change from Bsl - C13.D1 (n=17) | -1.2 (-2.2 to -0.1) |
| Change from Bsl - C14.D1 (n=17) | -1.4 (-2.3 to -0.5) |
| Change from Bsl - C15.D1 (n=12) | -1.0 (-2.0 to 0.1) |
| Change from Bsl - C16.D1 (n=12) | -0.5 (-2.1 to 1.1) |
| Change from Bsl - EOT (n=36) | -0.4 (-1.1 to 0.2) |
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.
| scores on a scale | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Bsl mean C1.D1 (n=47) | 112.0 (107.0 to 117.0) |
| Change from Bsl - C2.D1 (n=42) | 6.4 (2.2 to 10.6) |
| Change from Bsl - C3.D1 (n=31) | 7.2 (3.5 to 11.0) |
| Change from Bsl - C4.D1 (n=30) | 6.6 (0.2 to 13.0) |
| Change from Bsl - C5.D1 (n=33) | 4.9 (-1.5 to 11.4) |
| Change from Bsl - C6.D1 (n=31) | 8.2 (3.4 to 13.0) |
| Change from Bsl - C7.D1 (n=29) | 4.4 (-0.4 to 9.1) |
| Change from Bsl - C8.D1 (n=25) | 3.6 (-1.8 to 9.0) |
| Change from Bsl - C9.D1 (n=24) | 0.2 (-5.0 to 5.4) |
| Change from Bsl - C10.D1 (n=22) | 2.0 (-4.8 to 8.8) |
| Change from Bsl - C11.D1 (n=21) | 3.1 (-3.9 to 10.1) |
| Change from Bsl - C12.D1 (n=18) | 4.1 (-2.5 to 10.7) |
| Change from Bsl - C13.D1 (n=16) | 5.6 (-2.2 to 13.5) |
| Change from Bsl - C14.D1 (n=17) | 7.9 (0.6 to 15.2) |
| Change from Bsl - C15.D1 (n=12) | 4.1 (-2.5 to 10.7) |
| Change from Bsl - C16.D1 (n=12) | 6.2 (-1.9 to 14.2) |
| Change from Bsl - EOT (n=36) | 0.6 (-4.5 to 5.8) |
PSA modulation analyzed by the mean change in PSA response measured as ng/mL.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg | — | 28/55 (50.9%) | 55/55 (100%) |
| Event | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 8/55 |
| FatigueGeneral disorders | 2/55 |
| PyrexiaGeneral disorders | 2/55 |
| PneumoniaInfections and infestations | 2/55 |
| NeutropeniaBlood and lymphatic system disorders | 1/55 |
| PancytopeniaBlood and lymphatic system disorders | 1/55 |
| Arrhythmia supraventricularCardiac disorders | 1/55 |
| NauseaGastrointestinal disorders | 1/55 |
| Oesophagitis haemorrhagicGastrointestinal disorders | 1/55 |
| VomitingGastrointestinal disorders | 1/55 |
| Event | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| DiarrhoeaGastrointestinal disorders | 44/55 |
| FatigueGeneral disorders | 44/55 |
| AlopeciaSkin and subcutaneous tissue disorders | 35/55 |
| DysgeusiaNervous system disorders | 34/55 |
| NeutropeniaBlood and lymphatic system disorders | 33/55 |
| NauseaGastrointestinal disorders | 33/55 |
| LeukopeniaBlood and lymphatic system disorders | 23/55 |
| VomitingGastrointestinal disorders | 20/55 |
| Mucosal inflammationGeneral disorders | 20/55 |
| Oedema peripheralGeneral disorders | 20/55 |
| Age, Categorical(Participants) | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 26 |
| >=65 years | 29 |
| Age Continuous(years) | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Mean | 65.8 ± 9.1 |
| Sex: Female, Male(Participants) | SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg |
|---|---|
| Female | 0 |
| Male | 55 |
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