A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma. - Study Results

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Condition:	Carcinoma, Renal Cell
Intervention:	Drug: SU011248

	Sunitinib Malate
STARTED	106
COMPLETED	2
NOT COMPLETED	104
Adverse Event	22
Protocol Violation	1
Withdrawal by Subject	3
Lack of Efficacy	76
Decision of Sponsor	2

	Sunitinib Malate
Number of Participants [units: participants]	106
Age, Customized [units: participants]
< 65 years	87
>= 65 years	19
Gender [units: participants]
Female	39
Male	67

Outcome Measures

1. Primary:

Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST) [ From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter ]

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2. Secondary:

Time to Tumor Progression (TTP) [ From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter ]

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3. Secondary:

Duration of Response (DR) [ Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer ]

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4. Secondary:

Overall Survival (OS) [ From start of study treatment until death ]

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5. Secondary:

Progression-free Survival (PFS) [ From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death ]

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6. Secondary:

Percent Chance of Patient Survival [ From start of study treatment until death ]

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7. Secondary:

Observed Plasma Trough Concentrations of Sunitinib [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

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Measure Type	Secondary
Measure Title	Observed Plasma Trough Concentrations of Sunitinib
Measure Description	Observed plasma trough (predose) (Cmin) concentrations of sunitinib
Time Frame	Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic analysis population

Reporting Groups

	Description
Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Measured Values

	Sunitinib Malate
Number of Participants Analyzed [units: participants]	104
Observed Plasma Trough Concentrations of Sunitinib [units: nanograms per milliliter] Mean ± Standard Deviation
Cycle 1 Day 28 (n = 103)	46.82 ± 24.19
Cycle 2 Day 28 (n = 81)	50.13 ± 24.66
Cycle 3 Day 28 (n = 73)	49.36 ± 25.26
Cycle 4 Day 28 (n = 66)	53.18 ± 22.62
Cycle 5 Day 1 (n = 63)	1.55 ± 1.48
Cycle 6 Day 1 (n = 59)	1.44 ± 1.37
Cycle 7 Day 1 (n = 52)	1.51 ± 1.90
Cycle 8 Day 1 (n = 48)	1.60 ± 1.38
Cycle 9 Day 1 (n = 46)	1.60 ± 1.58
Cycle 10 Day 1 (n = 41)	1.69 ± 1.97
Cycle 11 Day 1 (n = 38)	2.05 ± 3.00
Cycle 12 Day 1 (n = 34)	1.72 ± 1.66
Cycle 13 Day 1 (n = 30)	1.74 ± 1.57
Cycle 14 Day 1 (n = 30)	1.60 ± 1.45
Cycle 15 Day 1 (n = 24)	1.56 ± 2.17
Cycle 16 Day 1 (n = 24)	1.46 ± 1.23
Cycle 17 Day 1 (n = 19)	1.42 ± 1.65
Cycle 18 Day 1 (n = 16)	2.20 ± 2.17
Cycle 19 Day 1 (n = 14)	1.34 ± 1.18
Cycle 20 Day 1 (n = 12)	2.96 ± 3.53
Cycle 21 Day 1 (n = 11)	2.53 ± 2.07
Cycle 22 Day 1 (n = 11)	2.18 ± 2.57
Cycle 23 Day 1 (n = 7)	3.14 ± 2.70
Cycle 24 Day 1 (n = 7)	2.75 ± 1.86
Cycle 25 Day 1 (n = 6)	1.99 ± 1.37
Cycle 26 Day 1 (n = 6)	2.46 ± 2.43
Cycle 27 Day 1 (n = 6)	1.20 ± 1.21
Cycle 28 Day 1 (n = 4)	1.75 ± 1.61
Cycle 29 Day 1 (n = 5)	2.93 ± 3.64
Cycle 30 Day 1 (n = 4)	1.02 ± 0.90

No statistical analysis provided for Observed Plasma Trough Concentrations of Sunitinib

8. Secondary:

Observed Plasma Trough Concentrations of Sunitinib Metabolite [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

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9. Secondary:

Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

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10. Secondary:

Dose Corrected Plasma Trough Concentrations of Sunitinib [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

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11. Secondary:

Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

Show Outcome Measure 11

12. Secondary:

Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

Show Outcome Measure 12

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 < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 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
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Results Point of Contact:

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

No publications provided by Pfizer

Publications automatically indexed to this study:

Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006 Jun 7;295(21):2516-24.

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181006
Study First Received:	February 13, 2004
Results First Received:	September 25, 2009
Last Updated:	November 4, 2009
ClinicalTrials.gov Identifier:	NCT00077974 History of Changes
Health Authority:	United States: Food and Drug Administration