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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00137436
• Collaborator: (none)
• Enrollment: 93
• Locations: 24
• Arm: 1
• Duration (Months): 53
• Patients Per Site: 3.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Drug: Docetaxel; Drug: Prednisone; Drug: SU011248	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Metastatic Hormone Refractory Prostate Cancer (HRPC)
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Experimental: A SU011248 in combination with docetaxel and prednisone

Drug: Docetaxel; 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).; Other Names: Taxotere; Sunitinib malate; SUTENT ; Drug: Prednisone; Prednisone Phase1/2 - 5 mg twice a day (BID), oral.; Drug: SU011248; 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).

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Prostate Specific Antigen (PSA) Response [Baseline, Day 1 of each 21-day cycle]

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

Secondary Outcome Measures

1. Time to PSA Progression [Baseline to first documentation of PSA progression up to 28 days after date of last dose]

   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.

2. Duration of PSA Response (DPR) [Baseline to first documentation of PSA progression up to 28 days after date of last dose]

   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.

3. Percentage of Participants With Objective Response Rate (ORR) [Baseline to first documentation of PSA progression up to 28 days after date of last dose]

   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.

4. Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC [Baseline (Cycle 1 Day 1 [C1.D1]), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14]

   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).

5. Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2 [Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14]

   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).

6. Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3 [Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14]

   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).

7. Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC [Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14]

   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.

8. Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2 [Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14]

   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.

9. Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3 [Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14]

   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.

10. Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) [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)]

    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.

11. Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) [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)]

    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.

12. Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) [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)]

    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.

13. Preliminary Assessment of PSA Modulation by SU011248 [Baseline to Day 28]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate

• Patients must have progressive hormone-refractory prostate cancer (HRPC): patients must have undergone primary hormone treatment (e.g. orchiectomy or gonadotropin releasing hormone analog with or without antiandrogens). For patients who received antiandrogen therapy, disease progression must have been determined after antiandrogen discontinuation

• Progressive disease based on either non-measurable disease and an elevated PSA OR measurable disease

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

• Prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF receptor inhibitor, platelet-derived growth factor (PDGF) receptor inhibitor or anti-angiogenic treatment of any kind including investigational therapy

• Prior chemotherapy

• Uncontrolled pain at baseline, impending complication from bone metastasis (fracture and/or compression) and/or presence of urinary obstruction (urinary retention, hydronephrosis)

• History of cardiac dysfunction, QT interval corrected for heart rate (QTc) >450 msec

• Central Nervous System (CNS) involvement

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Harvey	Illinois	United States	60426
2	Pfizer Investigational Site	Tinley Park	Illinois	United States	60477
3	Pfizer Investigational Site	Hobart	Indiana	United States	46342
4	Pfizer Investigational Site	Munster	Indiana	United States	46321
5	Pfizer Investigational Site	Durham	North Carolina	United States	27710
6	Pfizer Investigational Site	Portland	Oregon	United States	97239-3098
7	Pfizer Investigational Site	Portland	Oregon	United States	97239
8	Pfizer Investigational Site	Myrtle Beach	South Carolina	United States	29572
9	Pfizer Investigational Site	Clarksville	Tennessee	United States	37043
10	Pfizer Investigational Site	Franklin	Tennessee	United States	37067
11	Pfizer Investigational Site	Gallarin	Tennessee	United States	37066
12	Pfizer Investigational Site	Hermitage	Tennessee	United States	37076
13	Pfizer Investigational Site	Lebanon	Tennessee	United States	37087
14	Pfizer Investigational Site	Murfreesboro	Tennessee	United States	37130
15	Pfizer Investigational Site	Nashville	Tennessee	United States	37203
16	Pfizer Investigational Site	Nashville	Tennessee	United States	37205
17	Pfizer Investigational Site	Nashville	Tennessee	United States	37207
18	Pfizer Investigational Site	Nashville	Tennessee	United States	37211
19	Pfizer Investigational Site	Smithville	Tennessee	United States	37166
20	Pfizer Investigational Site	Smyrna	Tennessee	United States	37167
21	Pfizer Investigational Site	Tullahoma	Tennessee	United States	37388
22	Pfizer Investigational Site	Dallas	Texas	United States	75246
23	Pfizer Investigational Site	Houston	Texas	United States	77030
24	Pfizer Investigational Site	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00137436
• Other Study ID Numbers: A6181043
• First Posted: Aug 29, 2005
• Last Update Posted: Aug 29, 2011
• Last Verified: Aug 1, 2011

• Keywords provided by Pfizer: First-line treatment of metastatic hormone-refractory prostate cancer SUTENT in combination with docetaxel and prednisone
• Additional relevant MeSH terms: Prostatic Neoplasms; Prednisone; Docetaxel; Sunitinib

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	Sunitinib 37.5 milligrams (mg) plus (+) Docetaxel 75 mg per meters squared (mg/m^2) + Prednisone 5 mg given twice daily
Period Title: Overall Study
STARTED	55
COMPLETED	12
NOT COMPLETED	43

Baseline Characteristics

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
Overall Participants	55
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	26 47.3%
>=65 years	29 52.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.8 (9.1)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	55 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Prostate Specific Antigen (PSA) Response
Description	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

Outcome Measure Data

Analysis Population Description

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)

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
Measure Participants	55
Median (95% Confidence Interval) [percentage of participants]	56.4 102.5%

2. Secondary Outcome

Title	Time to PSA Progression
Description	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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
Measure Participants	55
Median (Full Range) [weeks]	42.1

3. Secondary Outcome

Title	Duration of PSA Response (DPR)
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
Measure Participants	31
Median (Full Range) [weeks]	39.1

4. Secondary Outcome

Title	Percentage of Participants With Objective Response Rate (ORR)
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
Measure Participants	33
Number (95% Confidence Interval) [percentage of participants]	42.4 77.1%

5. Secondary Outcome

Title	Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC
Description	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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
Measure Participants	55
Bsl median - PSA responder	622.70
Bsl median - PSA non-responder	639.70
C1D14 : C1D1 - PSA responder	1.06
C1D14 : C1D1 - PSA non-responder	1.07
C2.D1 : C1D1 - PSA responder	0.88
C2.D1 : C1D1 - PSA non-responder	0.93
C2.D14 : C1D1 - PSA responder	0.92
C2.D14 : C1D1 - PSA non-responder	0.95
C3.D1 : C1D1 - PSA responder	1.51
C3.D14 : C1D1 - PSA responder	0.97
C3.D14 : C1D1 - PSA non-responder	0.96

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C1D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.942
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C2.D1 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.323
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C2.D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.865
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C3.D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.873
	Comments
	Method	Wilcoxon rank-sum test
	Comments

6. Secondary Outcome

Title	Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2
Description	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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
Measure Participants	55
Bsl median - PSA responder	9889.00
Bsl median - PSA non-responder	10324.00
C1D14 : C1D1 - PSA responder	0.73
C1D14 : C1D1 - PSA non-responder	0.68
C2.D1 : C1D1 - PSA responder	0.80
C2.D1 : C1D1 - PSA non-responder	0.79
C2.D14 : C1D1 - PSA responder	0.67
C2.D14 : C1D1 - PSA non-responder	0.60
C3.D1 : C1D1 - PSA responder	0.81
C3.D14 : C1D1 - PSA responder	0.63
C3.D14 : C1D1 - PSA non-responder	0.67

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C1D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.736
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C2.D1 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.962
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C2.D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.185
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C3.D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.000
	Comments
	Method	Wilcoxon rank-sum test
	Comments

7. Secondary Outcome

Title	Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3
Description	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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
Measure Participants	55
Bsl median - PSA responder	22475.00
Bsl median - PSA non-responder	22070.00
C1D14 : C1D1 - PSA responder	0.69
C1D14 : C1D1 - PSA non-responder	0.73
C2.D1 : C1D1 - PSA responder	0.75
C2.D1 : C1D1 - PSA non-responder	0.75
C2.D14 : C1D1 - PSA responder	0.65
C2.D14 : C1D1 - PSA non-responder	0.72
C3.D1 : C1D1 - PSA responder	0.65
C3.D14 : C1D1 - PSA responder	0.56
C3.D14 : C1D1 - PSA non-responder	0.66

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C1D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.386
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C2.D1 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.904
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C2.D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.812
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C3.D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.490
	Comments
	Method	Wilcoxon rank-sum test
	Comments

8. Secondary Outcome

Title	Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC
Description	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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
Measure Participants	55
Bsl median - CR or PR	581.05
Bsl median - SD or PD	586.85
C1D14 : C1D1 - CR or PR	1.21
C1D14 : C1D1 - SD or PD	1.19
C2.D1 : C1D1 - CR or PR	0.89
C2.D1 : C1D1 - SD or PD	1.15
C2.D14 : C1D1 - CR or PR	0.92
C2.D14 : C1D1 - SD or PD	0.97
C3.D14 : C1D1 - CR or PR	0.88
C3.D14 : C1D1 - SD or PD	0.59

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C1D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.839
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C2.D1 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.219
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C2.D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.788
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C3.D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.164
	Comments
	Method	Wilcoxon rank-sum test
	Comments

9. Secondary Outcome

Title	Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2
Description	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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
Measure Participants	55
Bsl median - CR or PR	9837.50
Bsl median - SD or PD	9484.25
C1D14 : C1D1 - CR or PR	0.73
C1D14 : C1D1 - SD or PD	0.75
C2.D1 : C1D1 - CR or PR	0.83
C2.D1 : C1D1 - SD or PD	0.83
C2.D14 : C1D1 - CR or PR	0.68
C2.D14 : C1D1 - SD or PD	0.60
C3.D14 : C1D1 - CR or PR	0.63
C3.D14 : C1D1 - SD or PD	0.80

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C1D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.656
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C2.D1 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.628
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C2.D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.420
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C3.D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.296
	Comments
	Method	Wilcoxon rank-sum test
	Comments

10. Secondary Outcome

Title	Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3
Description	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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
Measure Participants	55
Bsl median - CR or PR	19975.00
Bsl median - SD or PD	22495.00
C1D14 : C1D1 - CR or PR	0.72
C1D14 : C1D1 - SD or PD	0.68
C2.D1 : C1D1 - CR or PR	0.78
C2.D1 : C1D1 - SD or PD	0.83
C2.D14 : C1D1 - CR or PR	0.69
C2.D14 : C1D1 - SD or PD	0.80
C3.D14 : C1D1 - CR or PR	0.61
C3.D14 : C1D1 - SD or PD	0.78

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C1D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.903
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C2.D1 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.434
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C2.D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.687
	Comments
	Method	Wilcoxon rank-sum test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Comments	C3.D14 : C1D1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.296
	Comments
	Method	Wilcoxon rank-sum test
	Comments

11. Secondary Outcome

Title	Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5)
Description	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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
Measure Participants	48
Bsl mean C1.D1 (n=48)	1.9
Change from Bsl - C2.D1 (n=42)	-1.0
Change from Bsl - C3.D1 (n=35)	-1.1
Change from Bsl - C4.D1 (n=30)	-0.8
Change from Bsl - C5.D1 (n=32)	-0.8
Change from Bsl - C6.D1 (n=32)	-0.8
Change from Bsl - C7.D1 (n=29)	-0.8
Change from Bsl - C8.D1 (n=26)	-0.7
Change from Bsl - C9.D1 (n=25)	-0.5
Change from Bsl - C10.D1 (n=22)	-0.7
Change from Bsl - C11.D1 (n=21)	-1.2
Change from Bsl - C12.D1 (n=18)	-0.8
Change from Bsl - C13.D1 (n=17)	-1.2
Change from Bsl - C14.D1 (n=17)	-1.3
Change from Bsl - C15.D1 (n=12)	-1.1
Change from Bsl - C16.D1 (n=12)	-0.5
Change from Bsl - EOT (n=37)	-0.3

12. Secondary Outcome

Title	Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G)
Description	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
Measure Participants	48
Bsl mean C1.D1 (n=48)	1.8
Change from Bsl - C2.D1 (n=41)	-0.7
Change from Bsl - C3.D1 (n=34)	-0.8
Change from Bsl - C4.D1 (n=30)	-0.5
Change from Bsl - C5.D1 (n=31)	-0.7
Change from Bsl - C6.D1 (n=32)	-0.6
Change from Bsl - C7.D1 (n=29)	-0.4
Change from Bsl - C8.D1 (n=26)	-0.5
Change from Bsl - C9.D1 (n=24)	-0.5
Change from Bsl - C10.D1 (n=21)	-0.4
Change from Bsl - C11.D1 (n=21)	-0.7
Change from Bsl - C12.D1 (n=18)	-0.8
Change from Bsl - C13.D1 (n=17)	-1.2
Change from Bsl - C14.D1 (n=17)	-1.4
Change from Bsl - C15.D1 (n=12)	-1.0
Change from Bsl - C16.D1 (n=12)	-0.5
Change from Bsl - EOT (n=36)	-0.4

13. Secondary Outcome

Title	Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale)
Description	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
Measure Participants	48
Bsl mean C1.D1 (n=47)	112.0
Change from Bsl - C2.D1 (n=42)	6.4
Change from Bsl - C3.D1 (n=31)	7.2
Change from Bsl - C4.D1 (n=30)	6.6
Change from Bsl - C5.D1 (n=33)	4.9
Change from Bsl - C6.D1 (n=31)	8.2
Change from Bsl - C7.D1 (n=29)	4.4
Change from Bsl - C8.D1 (n=25)	3.6
Change from Bsl - C9.D1 (n=24)	0.2
Change from Bsl - C10.D1 (n=22)	2.0
Change from Bsl - C11.D1 (n=21)	3.1
Change from Bsl - C12.D1 (n=18)	4.1
Change from Bsl - C13.D1 (n=16)	5.6
Change from Bsl - C14.D1 (n=17)	7.9
Change from Bsl - C15.D1 (n=12)	4.1
Change from Bsl - C16.D1 (n=12)	6.2
Change from Bsl - EOT (n=36)	0.6

14. Secondary Outcome

Title	Preliminary Assessment of PSA Modulation by SU011248
Description	PSA modulation analyzed by the mean change in PSA response measured as ng/mL.
Time Frame	Baseline to Day 28

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
Measure Participants	0

Adverse Events

Arm/Group Title	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Arm/Group Description	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
All Cause Mortality
	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Affected / at Risk (%)	# Events
Total	28/55 (50.9%)
Blood and lymphatic system disorders
Febrile neutropenia	8/55 (14.5%)
Neutropenia	1/55 (1.8%)
Pancytopenia	1/55 (1.8%)
Cardiac disorders
Arrhythmia supraventricular	1/55 (1.8%)
Gastrointestinal disorders
Nausea	1/55 (1.8%)
Oesophagitis haemorrhagic	1/55 (1.8%)
Vomiting	1/55 (1.8%)
General disorders
Chest pain	1/55 (1.8%)
Chills	1/55 (1.8%)
Fatigue	2/55 (3.6%)
Mucosal inflammation	1/55 (1.8%)
Multi-organ failure	1/55 (1.8%)
Pyrexia	2/55 (3.6%)
Hepatobiliary disorders
Cholestasis	1/55 (1.8%)
Immune system disorders
Hypersensitivity	1/55 (1.8%)
Infections and infestations
Bronchitis	1/55 (1.8%)
Diverticulitis	1/55 (1.8%)
Infection	1/55 (1.8%)
Perirectal abscess	1/55 (1.8%)
Pneumonia	2/55 (3.6%)
Pseudomonas infection	1/55 (1.8%)
Sepsis	1/55 (1.8%)
Tooth infection	1/55 (1.8%)
Urosepsis	1/55 (1.8%)
Injury, poisoning and procedural complications
Fall	1/55 (1.8%)
Fracture	1/55 (1.8%)
Investigations
Transaminases increased	1/55 (1.8%)
Metabolism and nutrition disorders
Decreased appetite	1/55 (1.8%)
Dehydration	1/55 (1.8%)
Hypoglycaemia	1/55 (1.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/55 (1.8%)
Nervous system disorders
Syncope	1/55 (1.8%)
Renal and urinary disorders
Urinary retention	1/55 (1.8%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/55 (1.8%)
Haemoptysis	1/55 (1.8%)
Pulmonary embolism	1/55 (1.8%)
Interstitial lung disease	1/55 (1.8%)
Vascular disorders
Haematoma	1/55 (1.8%)
Orthostatic hypotension	1/55 (1.8%)
Other (Not Including Serious) Adverse Events
	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
	Affected / at Risk (%)	# Events
Total	55/55 (100%)
Blood and lymphatic system disorders
Anaemia	17/55 (30.9%)
Leukopenia	23/55 (41.8%)
Lymphopenia	9/55 (16.4%)
Neutropenia	33/55 (60%)
Thrombocytopenia	11/55 (20%)
Eye disorders
Lacrimation increased	16/55 (29.1%)
Gastrointestinal disorders
Abdominal pain	7/55 (12.7%)
Constipation	12/55 (21.8%)
Diarrhoea	44/55 (80%)
Dry mouth	5/55 (9.1%)
Dyspepsia	12/55 (21.8%)
Dysphagia	4/55 (7.3%)
Gastrooesophageal reflux disease	7/55 (12.7%)
Gingivitis	3/55 (5.5%)
Glossodynia	10/55 (18.2%)
Haemorrhoids	3/55 (5.5%)
Mouth ulceration	3/55 (5.5%)
Nausea	33/55 (60%)
Oral pain	11/55 (20%)
Stomatitis	7/55 (12.7%)
Vomiting	20/55 (36.4%)
General disorders
Asthenia	8/55 (14.5%)
Chest pain	7/55 (12.7%)
Chills	7/55 (12.7%)
Fatigue	44/55 (80%)
Influenza like illness	6/55 (10.9%)
Mucosal inflammation	20/55 (36.4%)
Oedema peripheral	20/55 (36.4%)
Pain	6/55 (10.9%)
Pyrexia	15/55 (27.3%)
Hepatobiliary disorders
Hyperbilirubinaemia	3/55 (5.5%)
Infections and infestations
Bronchitis	3/55 (5.5%)
Rhinitis	4/55 (7.3%)
Sinusitis	3/55 (5.5%)
Tooth abscess	4/55 (7.3%)
Upper respiratory tract infection	4/55 (7.3%)
Urinary tract infection	7/55 (12.7%)
Injury, poisoning and procedural complications
Contusion	7/55 (12.7%)
Investigations
Alanine aminotransferase increased	4/55 (7.3%)
Aspartate aminotransferase increased	6/55 (10.9%)
Blood creatinine increased	6/55 (10.9%)
Haemoglobin decreased	4/55 (7.3%)
Weight decreased	6/55 (10.9%)
Metabolism and nutrition disorders
Decreased appetite	14/55 (25.5%)
Dehydration	3/55 (5.5%)
Hyperglycaemia	19/55 (34.5%)
Hyperkalaemia	3/55 (5.5%)
Hypoalbuminaemia	14/55 (25.5%)
Hypocalcaemia	6/55 (10.9%)
Hypoglycaemia	4/55 (7.3%)
Hypokalaemia	4/55 (7.3%)
Hypomagnesaemia	5/55 (9.1%)
Hyponatraemia	5/55 (9.1%)
Hypophosphataemia	12/55 (21.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	13/55 (23.6%)
Back pain	10/55 (18.2%)
Bone pain	5/55 (9.1%)
Flank pain	3/55 (5.5%)
Muscle spasms	6/55 (10.9%)
Muscular weakness	3/55 (5.5%)
Musculoskeletal chest pain	5/55 (9.1%)
Musculoskeletal pain	3/55 (5.5%)
Myalgia	4/55 (7.3%)
Neck pain	4/55 (7.3%)
Pain in extremity	11/55 (20%)
Nervous system disorders
Dizziness	13/55 (23.6%)
Dysgeusia	34/55 (61.8%)
Headache	8/55 (14.5%)
Hypoaesthesia	4/55 (7.3%)
Neuropathy peripheral	13/55 (23.6%)
Peripheral sensory neuropathy	7/55 (12.7%)
Tremor	3/55 (5.5%)
Psychiatric disorders
Anxiety	3/55 (5.5%)
Renal and urinary disorders
Dysuria	11/55 (20%)
Haematuria	4/55 (7.3%)
Incontinence	4/55 (7.3%)
Nocturia	3/55 (5.5%)
Urinary incontinence	3/55 (5.5%)
Respiratory, thoracic and mediastinal disorders
Cough	14/55 (25.5%)
Dysphonia	9/55 (16.4%)
Dyspnoea	15/55 (27.3%)
Dyspnoea exertional	5/55 (9.1%)
Epistaxis	15/55 (27.3%)
Nasal congestion	4/55 (7.3%)
Oropharyngeal pain	9/55 (16.4%)
Rhinorrhoea	4/55 (7.3%)
Skin and subcutaneous tissue disorders
Alopecia	35/55 (63.6%)
Dry skin	12/55 (21.8%)
Hair colour changes	3/55 (5.5%)
Hyperhidrosis	4/55 (7.3%)
Nail disorder	14/55 (25.5%)
Night sweats	3/55 (5.5%)
Palmar-plantar erythrodysaesthesia syndrome	15/55 (27.3%)
Rash	15/55 (27.3%)
Skin depigmentation	3/55 (5.5%)
Skin discolouration	8/55 (14.5%)
Swelling face	4/55 (7.3%)
Surgical and medical procedures
Sinus operation	3/55 (5.5%)
Vascular disorders
Flushing	4/55 (7.3%)
Haematoma	3/55 (5.5%)
Hot flush	3/55 (5.5%)
Hypertension	7/55 (12.7%)
Deep vein thrombosis	3/55 (5.5%)

Limitations/Caveats

Per FDAAA, only the Phase 2 study results are posted.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.