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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostatic Neoplasms
Interventions:	Drug: Docetaxel Drug: Prednisone Drug: SU011248

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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

Participant Flow: Overall Study

	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
STARTED	55 ^[1]
COMPLETED	12
NOT COMPLETED	43
Adverse Event	13
Death	2
Lack of Efficacy	17
Withdrawal by Subject	6
Unspecified	5

[1]	Phase 2 did not include 38 participants from Phase 1.

Baseline Characteristics

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Reporting Groups

	Description
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg	SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily

Baseline Measures

	SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg
Number of Participants [units: participants]	55
Age [units: participants]
<=18 years	0
Between 18 and 65 years	26
>=65 years	29
Age [units: years] Mean ± Standard Deviation	65.8 ± 9.1
Gender [units: participants]
Female	0
Male	55

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

10. Secondary:

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

Show Outcome Measure 10

11. Secondary:

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

Show Outcome Measure 11

12. Secondary:

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

Show Outcome Measure 12

13. Secondary:

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

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14. Secondary:

Preliminary Assessment of PSA Modulation by SU011248 [ Time Frame: Baseline to Day 28 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Per FDAAA, only the Phase 2 study results are posted.

Results Point of Contact:

Name/Title: Pfizer Clinical Trials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00137436 History of Changes
Other Study ID Numbers:	A6181043
Study First Received:	August 26, 2005
Results First Received:	May 28, 2009
Last Updated:	August 25, 2011
Health Authority:	United States: Food and Drug Administration