Trial Outcomes & Findings for Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer (NCT NCT00137436)

NCT ID: NCT00137436

Last Updated: 2011-08-29

Results Overview

PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 93 participants
• Primary outcome timeframe: Baseline, Day 1 of each 21-day cycle
• Results posted on: 2011-08-29

Participant Flow

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.

Participant milestones

Measure	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
Overall Study STARTED	55
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	43

Reasons for withdrawal

Measure	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
Overall Study Adverse Event	13
Overall Study Death	2
Overall Study Lack of Efficacy	17
Overall Study Withdrawal by Subject	6
Overall Study Other	5

Baseline Characteristics

Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer

Baseline characteristics by cohort

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=55 Participants SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants
Age Continuous	65.8 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 1 of each 21-day cycle

Population: 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)

PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed.

Outcome measures

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=55 Participants SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Percentage of Participants With Prostate Specific Antigen (PSA) Response	56.4 percentage of participants Interval 42.3 to 69.7

SECONDARY outcome

Timeframe: Baseline to first documentation of PSA progression up to 28 days after date of last dose

Population: ITT

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.

Outcome measures

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=55 Participants SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Time to PSA Progression	42.1 weeks Interval 33.1 to upper range not reached; the data was not mature.

SECONDARY outcome

Timeframe: Baseline to first documentation of PSA progression up to 28 days after date of last dose

Population: ITT; DPR only calculated for the subgroup of patients with PSA response rate.

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.

Outcome measures

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=31 Participants SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Duration of PSA Response (DPR)	39.1 weeks Interval 36.0 to upper range not reached; the data was not mature.

SECONDARY outcome

Timeframe: Baseline to first documentation of PSA progression up to 28 days after date of last dose

Population: ITT; N=participants with measurable disease at baseline, received at least 1 dose of study medication, and had correct histological cancer type.

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.

Outcome measures

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=33 Participants SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Percentage of Participants With Objective Response Rate (ORR)	42.4 percentage of participants Interval 25.5 to 60.8

SECONDARY outcome

Timeframe: Baseline (Cycle 1 Day 1 [C1.D1]), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14

Population: ITT

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).

Outcome measures

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=55 Participants SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC Bsl median - PSA responder	622.70 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC Bsl median - PSA non-responder	639.70 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC C1D14 : C1D1 - PSA responder	1.06 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC C1D14 : C1D1 - PSA non-responder	1.07 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC C2.D1 : C1D1 - PSA responder	0.88 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC C2.D1 : C1D1 - PSA non-responder	0.93 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC C2.D14 : C1D1 - PSA responder	0.92 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC C2.D14 : C1D1 - PSA non-responder	0.95 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC C3.D1 : C1D1 - PSA responder	1.51 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC C3.D14 : C1D1 - PSA responder	0.97 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC C3.D14 : C1D1 - PSA non-responder	0.96 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.

SECONDARY outcome

Timeframe: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14

Population: ITT

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).

Outcome measures

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=55 Participants SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2 Bsl median - PSA responder	9889.00 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2 Bsl median - PSA non-responder	10324.00 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2 C1D14 : C1D1 - PSA responder	0.73 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2 C1D14 : C1D1 - PSA non-responder	0.68 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2 C2.D1 : C1D1 - PSA responder	0.80 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2 C2.D1 : C1D1 - PSA non-responder	0.79 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2 C2.D14 : C1D1 - PSA responder	0.67 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2 C2.D14 : C1D1 - PSA non-responder	0.60 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2 C3.D1 : C1D1 - PSA responder	0.81 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2 C3.D14 : C1D1 - PSA responder	0.63 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2 C3.D14 : C1D1 - PSA non-responder	0.67 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.

SECONDARY outcome

Timeframe: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14

Population: ITT

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).

Outcome measures

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=55 Participants SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3 Bsl median - PSA responder	22475.00 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3 Bsl median - PSA non-responder	22070.00 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3 C1D14 : C1D1 - PSA responder	0.69 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3 C1D14 : C1D1 - PSA non-responder	0.73 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3 C2.D1 : C1D1 - PSA responder	0.75 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3 C2.D1 : C1D1 - PSA non-responder	0.75 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3 C2.D14 : C1D1 - PSA responder	0.65 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3 C2.D14 : C1D1 - PSA non-responder	0.72 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3 C3.D1 : C1D1 - PSA responder	0.65 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3 C3.D14 : C1D1 - PSA responder	0.56 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3 C3.D14 : C1D1 - PSA non-responder	0.66 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.

SECONDARY outcome

Timeframe: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14

Population: ITT

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.

Outcome measures

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=55 Participants SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC Bsl median - CR or PR	581.05 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC Bsl median - SD or PD	586.85 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC C1D14 : C1D1 - CR or PR	1.21 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC C1D14 : C1D1 - SD or PD	1.19 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC C2.D1 : C1D1 - CR or PR	0.89 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC C2.D1 : C1D1 - SD or PD	1.15 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC C2.D14 : C1D1 - CR or PR	0.92 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC C2.D14 : C1D1 - SD or PD	0.97 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC C3.D14 : C1D1 - CR or PR	0.88 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC C3.D14 : C1D1 - SD or PD	0.59 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.

SECONDARY outcome

Timeframe: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14

Population: ITT

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.

Outcome measures

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=55 Participants SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2 Bsl median - CR or PR	9837.50 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2 Bsl median - SD or PD	9484.25 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2 C1D14 : C1D1 - CR or PR	0.73 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2 C1D14 : C1D1 - SD or PD	0.75 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2 C2.D1 : C1D1 - CR or PR	0.83 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2 C2.D1 : C1D1 - SD or PD	0.83 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2 C2.D14 : C1D1 - CR or PR	0.68 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2 C2.D14 : C1D1 - SD or PD	0.60 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2 C3.D14 : C1D1 - CR or PR	0.63 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2 C3.D14 : C1D1 - SD or PD	0.80 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.

SECONDARY outcome

Timeframe: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14

Population: ITT

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.

Outcome measures

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=55 Participants SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3 Bsl median - CR or PR	19975.00 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3 Bsl median - SD or PD	22495.00 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3 C1D14 : C1D1 - CR or PR	0.72 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3 C1D14 : C1D1 - SD or PD	0.68 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3 C2.D1 : C1D1 - CR or PR	0.78 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3 C2.D1 : C1D1 - SD or PD	0.83 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3 C2.D14 : C1D1 - CR or PR	0.69 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3 C2.D14 : C1D1 - SD or PD	0.80 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3 C3.D14 : C1D1 - CR or PR	0.61 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3 C3.D14 : C1D1 - SD or PD	0.78 pg/mL Measure of dispersion was not calculated for the median; the data was not mature.

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=48 Participants SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Bsl mean C1.D1 (n=48)	1.9 scores on a scale Interval 1.4 to 2.4
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - C2.D1 (n=42)	-1.0 scores on a scale Interval -1.4 to -0.5
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - C3.D1 (n=35)	-1.1 scores on a scale Interval -1.7 to -0.5
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - C4.D1 (n=30)	-0.8 scores on a scale Interval -1.7 to 0.0
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - C5.D1 (n=32)	-0.8 scores on a scale Interval -1.7 to 0.1
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - C6.D1 (n=32)	-0.8 scores on a scale Interval -1.6 to 0.0
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - C7.D1 (n=29)	-0.8 scores on a scale Interval -1.6 to -0.1
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - C8.D1 (n=26)	-0.7 scores on a scale Interval -1.7 to 0.3
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - C9.D1 (n=25)	-0.5 scores on a scale Interval -1.3 to 0.4
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - C10.D1 (n=22)	-0.7 scores on a scale Interval -1.5 to 0.0
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - C11.D1 (n=21)	-1.2 scores on a scale Interval -2.0 to -0.5
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - C12.D1 (n=18)	-0.8 scores on a scale Interval -1.8 to 0.1
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - C13.D1 (n=17)	-1.2 scores on a scale Interval -2.1 to -0.3
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - C14.D1 (n=17)	-1.3 scores on a scale Interval -2.1 to -0.6
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - C15.D1 (n=12)	-1.1 scores on a scale Interval -2.2 to 0.1
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - C16.D1 (n=12)	-0.5 scores on a scale Interval -2.6 to 1.6
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) Change from Bsl - EOT (n=37)	-0.3 scores on a scale Interval -1.0 to 0.3

SECONDARY outcome

Timeframe: 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)

Population: PRO evaluable population; (n)=number of participants with evaluable data at observation.

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.

Outcome measures

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=48 Participants SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Bsl mean C1.D1 (n=48)	1.8 scores on a scale Interval 1.2 to 2.4
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - C2.D1 (n=41)	-0.7 scores on a scale Interval -1.1 to -0.3
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - C3.D1 (n=34)	-0.8 scores on a scale Interval -1.5 to -0.2
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - C4.D1 (n=30)	-0.5 scores on a scale Interval -1.4 to 0.5
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - C5.D1 (n=31)	-0.7 scores on a scale Interval -1.8 to 0.4
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - C6.D1 (n=32)	-0.6 scores on a scale Interval -1.4 to 0.3
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - C7.D1 (n=29)	-0.4 scores on a scale Interval -1.1 to 0.4
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - C8.D1 (n=26)	-0.5 scores on a scale Interval -1.3 to 0.3
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - C9.D1 (n=24)	-0.5 scores on a scale Interval -1.3 to 0.3
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - C10.D1 (n=21)	-0.4 scores on a scale Interval -1.3 to 0.5
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - C11.D1 (n=21)	-0.7 scores on a scale Interval -1.7 to 0.3
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - C12.D1 (n=18)	-0.8 scores on a scale Interval -2.0 to 0.4
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - C13.D1 (n=17)	-1.2 scores on a scale Interval -2.2 to -0.1
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - C14.D1 (n=17)	-1.4 scores on a scale Interval -2.3 to -0.5
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - C15.D1 (n=12)	-1.0 scores on a scale Interval -2.0 to 0.1
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - C16.D1 (n=12)	-0.5 scores on a scale Interval -2.1 to 1.1
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) Change from Bsl - EOT (n=36)	-0.4 scores on a scale Interval -1.1 to 0.2

SECONDARY outcome

Timeframe: 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)

Population: PRO evaluable population; (n)=number of participants with evaluable data at observation.

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.

Outcome measures

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=48 Participants SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Bsl mean C1.D1 (n=47)	112.0 scores on a scale Interval 107.0 to 117.0
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - C2.D1 (n=42)	6.4 scores on a scale Interval 2.2 to 10.6
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - C3.D1 (n=31)	7.2 scores on a scale Interval 3.5 to 11.0
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - C4.D1 (n=30)	6.6 scores on a scale Interval 0.2 to 13.0
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - C5.D1 (n=33)	4.9 scores on a scale Interval -1.5 to 11.4
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - C6.D1 (n=31)	8.2 scores on a scale Interval 3.4 to 13.0
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - C7.D1 (n=29)	4.4 scores on a scale Interval -0.4 to 9.1
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - C8.D1 (n=25)	3.6 scores on a scale Interval -1.8 to 9.0
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - C9.D1 (n=24)	0.2 scores on a scale Interval -5.0 to 5.4
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - C10.D1 (n=22)	2.0 scores on a scale Interval -4.8 to 8.8
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - C11.D1 (n=21)	3.1 scores on a scale Interval -3.9 to 10.1
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - C12.D1 (n=18)	4.1 scores on a scale Interval -2.5 to 10.7
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - C13.D1 (n=16)	5.6 scores on a scale Interval -2.2 to 13.5
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - C14.D1 (n=17)	7.9 scores on a scale Interval 0.6 to 15.2
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - C15.D1 (n=12)	4.1 scores on a scale Interval -2.5 to 10.7
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - C16.D1 (n=12)	6.2 scores on a scale Interval -1.9 to 14.2
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) Change from Bsl - EOT (n=36)	0.6 scores on a scale Interval -4.5 to 5.8

SECONDARY outcome

Timeframe: Baseline to Day 28

Population: 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.

PSA modulation analyzed by the mean change in PSA response measured as ng/mL.

Outcome measures

Outcome data not reported

Adverse Events

SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg

Serious events: 28 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=55 participants at risk SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Blood and lymphatic system disorders Febrile neutropenia	14.5% 8/55
Blood and lymphatic system disorders Neutropenia	1.8% 1/55
Blood and lymphatic system disorders Pancytopenia	1.8% 1/55
Cardiac disorders Arrhythmia supraventricular	1.8% 1/55
Gastrointestinal disorders Nausea	1.8% 1/55
Gastrointestinal disorders Oesophagitis haemorrhagic	1.8% 1/55
Gastrointestinal disorders Vomiting	1.8% 1/55
General disorders Chest pain	1.8% 1/55
General disorders Chills	1.8% 1/55
General disorders Fatigue	3.6% 2/55
General disorders Mucosal inflammation	1.8% 1/55
General disorders Multi-organ failure	1.8% 1/55
General disorders Pyrexia	3.6% 2/55
Hepatobiliary disorders Cholestasis	1.8% 1/55
Immune system disorders Hypersensitivity	1.8% 1/55
Infections and infestations Bronchitis	1.8% 1/55
Infections and infestations Diverticulitis	1.8% 1/55
Infections and infestations Infection	1.8% 1/55
Infections and infestations Perirectal abscess	1.8% 1/55
Infections and infestations Pneumonia	3.6% 2/55
Infections and infestations Pseudomonas infection	1.8% 1/55
Infections and infestations Sepsis	1.8% 1/55
Infections and infestations Tooth infection	1.8% 1/55
Infections and infestations Urosepsis	1.8% 1/55
Injury, poisoning and procedural complications Fall	1.8% 1/55
Injury, poisoning and procedural complications Fracture	1.8% 1/55
Investigations Transaminases increased	1.8% 1/55
Metabolism and nutrition disorders Decreased appetite	1.8% 1/55
Metabolism and nutrition disorders Dehydration	1.8% 1/55
Metabolism and nutrition disorders Hypoglycaemia	1.8% 1/55
Musculoskeletal and connective tissue disorders Arthralgia	1.8% 1/55
Nervous system disorders Syncope	1.8% 1/55
Renal and urinary disorders Urinary retention	1.8% 1/55
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.8% 1/55
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.8% 1/55
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.8% 1/55
Vascular disorders Haematoma	1.8% 1/55
Vascular disorders Orthostatic hypotension	1.8% 1/55
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.8% 1/55

Other adverse events

Measure	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg n=55 participants at risk SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m\^2 + Prednisone 5 mg given twice daily
Blood and lymphatic system disorders Anaemia	30.9% 17/55
Blood and lymphatic system disorders Leukopenia	41.8% 23/55
Blood and lymphatic system disorders Lymphopenia	16.4% 9/55
Blood and lymphatic system disorders Neutropenia	60.0% 33/55
Blood and lymphatic system disorders Thrombocytopenia	20.0% 11/55
Eye disorders Lacrimation increased	29.1% 16/55
Gastrointestinal disorders Abdominal pain	12.7% 7/55
Gastrointestinal disorders Constipation	21.8% 12/55
Gastrointestinal disorders Diarrhoea	80.0% 44/55
Gastrointestinal disorders Dry mouth	9.1% 5/55
Gastrointestinal disorders Dyspepsia	21.8% 12/55
Gastrointestinal disorders Dysphagia	7.3% 4/55
Gastrointestinal disorders Gastrooesophageal reflux disease	12.7% 7/55
Gastrointestinal disorders Gingivitis	5.5% 3/55
Gastrointestinal disorders Glossodynia	18.2% 10/55
Gastrointestinal disorders Haemorrhoids	5.5% 3/55
Gastrointestinal disorders Mouth ulceration	5.5% 3/55
Gastrointestinal disorders Nausea	60.0% 33/55
Gastrointestinal disorders Oral pain	20.0% 11/55
Gastrointestinal disorders Stomatitis	12.7% 7/55
Gastrointestinal disorders Vomiting	36.4% 20/55
General disorders Asthenia	14.5% 8/55
General disorders Chest pain	12.7% 7/55
General disorders Chills	12.7% 7/55
General disorders Fatigue	80.0% 44/55
General disorders Influenza like illness	10.9% 6/55
General disorders Mucosal inflammation	36.4% 20/55
General disorders Oedema peripheral	36.4% 20/55
General disorders Pain	10.9% 6/55
General disorders Pyrexia	27.3% 15/55
Hepatobiliary disorders Hyperbilirubinaemia	5.5% 3/55
Infections and infestations Bronchitis	5.5% 3/55
Infections and infestations Rhinitis	7.3% 4/55
Infections and infestations Sinusitis	5.5% 3/55
Infections and infestations Tooth abscess	7.3% 4/55
Infections and infestations Upper respiratory tract infection	7.3% 4/55
Infections and infestations Urinary tract infection	12.7% 7/55
Injury, poisoning and procedural complications Contusion	12.7% 7/55
Investigations Alanine aminotransferase increased	7.3% 4/55
Investigations Aspartate aminotransferase increased	10.9% 6/55
Investigations Blood creatinine increased	10.9% 6/55
Investigations Haemoglobin decreased	7.3% 4/55
Investigations Weight decreased	10.9% 6/55
Metabolism and nutrition disorders Decreased appetite	25.5% 14/55
Metabolism and nutrition disorders Dehydration	5.5% 3/55
Metabolism and nutrition disorders Hyperglycaemia	34.5% 19/55
Metabolism and nutrition disorders Hyperkalaemia	5.5% 3/55
Metabolism and nutrition disorders Hypoalbuminaemia	25.5% 14/55
Metabolism and nutrition disorders Hypocalcaemia	10.9% 6/55
Metabolism and nutrition disorders Hypoglycaemia	7.3% 4/55
Metabolism and nutrition disorders Hypokalaemia	7.3% 4/55
Metabolism and nutrition disorders Hypomagnesaemia	9.1% 5/55
Metabolism and nutrition disorders Hyponatraemia	9.1% 5/55
Metabolism and nutrition disorders Hypophosphataemia	21.8% 12/55
Musculoskeletal and connective tissue disorders Arthralgia	23.6% 13/55
Musculoskeletal and connective tissue disorders Back pain	18.2% 10/55
Musculoskeletal and connective tissue disorders Bone pain	9.1% 5/55
Musculoskeletal and connective tissue disorders Flank pain	5.5% 3/55
Musculoskeletal and connective tissue disorders Muscle spasms	10.9% 6/55
Musculoskeletal and connective tissue disorders Muscular weakness	5.5% 3/55
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	9.1% 5/55
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.5% 3/55
Musculoskeletal and connective tissue disorders Myalgia	7.3% 4/55
Musculoskeletal and connective tissue disorders Neck pain	7.3% 4/55
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 11/55
Nervous system disorders Dizziness	23.6% 13/55
Nervous system disorders Dysgeusia	61.8% 34/55
Nervous system disorders Headache	14.5% 8/55
Nervous system disorders Hypoaesthesia	7.3% 4/55
Nervous system disorders Neuropathy peripheral	23.6% 13/55
Nervous system disorders Peripheral sensory neuropathy	12.7% 7/55
Nervous system disorders Tremor	5.5% 3/55
Psychiatric disorders Anxiety	5.5% 3/55
Renal and urinary disorders Dysuria	20.0% 11/55
Renal and urinary disorders Haematuria	7.3% 4/55
Renal and urinary disorders Incontinence	7.3% 4/55
Renal and urinary disorders Nocturia	5.5% 3/55
Renal and urinary disorders Urinary incontinence	5.5% 3/55
Respiratory, thoracic and mediastinal disorders Cough	25.5% 14/55
Respiratory, thoracic and mediastinal disorders Dysphonia	16.4% 9/55
Respiratory, thoracic and mediastinal disorders Dyspnoea	27.3% 15/55
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	9.1% 5/55
Respiratory, thoracic and mediastinal disorders Epistaxis	27.3% 15/55
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.3% 4/55
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.4% 9/55
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.3% 4/55
Skin and subcutaneous tissue disorders Alopecia	63.6% 35/55
Skin and subcutaneous tissue disorders Dry skin	21.8% 12/55
Skin and subcutaneous tissue disorders Hair colour changes	5.5% 3/55
Skin and subcutaneous tissue disorders Hyperhidrosis	7.3% 4/55
Skin and subcutaneous tissue disorders Nail disorder	25.5% 14/55
Skin and subcutaneous tissue disorders Night sweats	5.5% 3/55
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	27.3% 15/55
Skin and subcutaneous tissue disorders Rash	27.3% 15/55
Skin and subcutaneous tissue disorders Skin depigmentation	5.5% 3/55
Skin and subcutaneous tissue disorders Skin discolouration	14.5% 8/55
Skin and subcutaneous tissue disorders Swelling face	7.3% 4/55
Surgical and medical procedures Sinus operation	5.5% 3/55
Vascular disorders Flushing	7.3% 4/55
Vascular disorders Haematoma	5.5% 3/55
Vascular disorders Hot flush	5.5% 3/55
Vascular disorders Hypertension	12.7% 7/55
Vascular disorders Deep vein thrombosis	5.5% 3/55

Additional Information

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Phone: 1-800-718-1021

Email: ClinicalTrials.govCallCenter@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER