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
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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)

Participant Flow:   Overall Study

	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

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)

Baseline Measures

	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

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 ]

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 ]

3.  Secondary:

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

4.  Secondary:

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

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 ]

6.  Secondary:

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

7.  Secondary:

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

8.  Secondary:

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

9.  Secondary:

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

10.  Secondary:

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

11.  Secondary:

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

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 ]