Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment began (medical clinic) in December 2003. Study was unblinded on 27 January 2005 (end of Double-blind treatment). Subjects experiencing disease progression could crossover to Open-label treatment. Open-label data collection ended May 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
361 subjects randomized to double-blind treatment in 2:1 ratio (sunitinib vs. Placebo). 255 subjects continued on or crossed over to Open-label treatment.

Reporting Groups

	Description
Sunitinib Double-Blind Treatment	Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
Placebo Double-Blind Treatment	Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Sunitinib Open-Label Treatment	Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.

Participant Flow for 2 periods

	Sunitinib Double-Blind Treatment	Placebo Double-Blind Treatment	Sunitinib Open-Label Treatment
STARTED	243[1]	118[2]	0
Received Double-Blind Treatment	228[3]	114[4]	0
Crossed Over to Open-Label Treatment	152	103	0
COMPLETED	152[5]	103[6]	0
NOT COMPLETED	91	15	0
Adverse Event	23	4	0
Withdrawal by Subject	7	4	0
Lost to Follow-up	1	0	0
Lack of Efficacy	58	6	0
Decision of Sponsor	0	1	0
No study medication taken	2	0	0

	Sunitinib Double-Blind Treatment	Placebo Double-Blind Treatment	Sunitinib Open-Label Treatment
STARTED	0	0	255
COMPLETED	0	0	0
NOT COMPLETED	0	0	255
Lack of Efficacy	0	0	174
Adverse Event	0	0	51
Withdrawal by Subject	0	0	12
Decision of Sponsor	0	0	8
Protocol Violation	0	0	1
enrolled in a separate continuation	0	0	9

Reporting Groups

	Description
Sunitinib Double-Blind Treatment	Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
Placebo Double-Blind Treatment	Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.

Baseline Measures

	Sunitinib Double-Blind Treatment	Placebo Double-Blind Treatment	Total
Number of Participants   [units: participants]	243	118	361
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	170	81	251
>=65 years	73	37	110
Gender   [units: participants]
Female	91	71	162
Male	152	47	199

1.  Primary:

Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase   [ Day 28 of each 6-week cycle : duration of double-blind treatment phase ]

2.  Primary:

Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study   [ Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV) ]

3.  Secondary:

Progression Free Survival (PFS)   [ Day 28 of each cycle : duration of double-blind treatment phase ]

4.  Secondary:

Overall Survival Status of Subjects   [ clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ]

5.  Secondary:

Overall Survival   [ clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ]

6.  Secondary:

Overall Survival Based on the Rank Preserving Structural Failure Time Method   [ clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ]

7.  Secondary:

Best Overall Tumor Response During Double-blind Treatment Phase   [ Day 28 of each cycle : duration of double-blind treatment phase ]

8.  Secondary:

Confirmed Objective Response (CR or PR) in Subjects   [ Day 28 of each cycle : duration of double-blind treatment phase ]

9.  Secondary:

Time to Tumor Response (TTR)   [ Day 28 of each cycle : duration of double-blind treatment phase ]

10.  Secondary:

Duration of Performance Status Maintenance   [ Day 28 of each cycle : duration of double-blind treatment phase ]

11.  Secondary:

Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)   [ Day 1 & 28 of each cycle : duration of double-blind treatment phase ]

12.  Secondary:

Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)   [ Day 1 & 28 of each cycle : duration of double-blind treatment phase ]

13.  Secondary:

Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS)   [ Day 1 & 28 of each cycle : duration of double-blind treatment phase ]

14.  Secondary:

Change From Baseline in EQ-5D Health State Profile Index   [ Day 1 & 28 of each cycle : duration of double-blind treatment phase ]