Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer

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
Sorafenib (Nexavar, BAY43-9006)	Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
Placebo	Participants received 2 matching placebo tablets per oral twice daily

Participant Flow for 2 periods

Period 1:   Double-blind Treatment

	Sorafenib (Nexavar, BAY43-9006)	Placebo
STARTED	123	123
COMPLETED	58 [1]	103 [2]
NOT COMPLETED	65	20
Adverse Event	46	8
Physician Decision	1	3
Protocol Violation	0	2
Withdrawal by Subject	17	7
Non-compliant with study medication	1	0

Period 2:   Follow-up

	Sorafenib (Nexavar, BAY43-9006)	Placebo
STARTED	105 [1]	91 [2]
COMPLETED	85 [3]	78 [3]
NOT COMPLETED	20	13
Withdrawal by Subject	2	0
Lost to Follow-up	2	1
Death	16	12

Reporting Groups

	Description
Sorafenib (Nexavar, BAY43-9006)	Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
Placebo	Participants received 2 matching placebo tablets per oral twice daily
Total	Total of all reporting groups

Baseline Measures

	Sorafenib (Nexavar, BAY43-9006)	Placebo	Total
Number of Participants   [units: participants]	123	123	246
Age   [units: Years] Mean ± Standard Deviation	56.9  ± 10.4	54.4  ± 10.3	55.7  ± 10.4
Age, Customized   [units: Participants]
< 65 years	95	99	194
≥ 65 - < 75 years	23	23	46
≥ 75 years	5	1	6
Gender   [units: Participants]
Female	123	123	246
Male	0	0	0
Performance status, Eastern Cooperative Oncology Group (ECOG) [1] [units: Participants]
0=Fully active without restriction	89	92	181
1=Restricted in physically strenuous activity	32	30	62
2=Ambulatory, capable of all selfcare	1	0	1
Missing	1	1	2
Type of cancer [2] [units: Participants]
Ovarian cancer	115	114	229
Peritoneal cancer	8	9	17
Previous Intra-peritoneal (IP) chemotherapy [3] [units: Participants]
Yes	5	4	9
No	118	119	237
Surgical cytoreduction [4] [units: Participants]
Optimal	105	105	210
Suboptimal	10	10	20
Missing	8	8	16

1.  Primary:

Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment   [ Time Frame: From randomization of the first patient until 32.5 months later, assessed every 8 weeks ]

2.  Secondary:

Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level   [ Time Frame: From randomization of the first patient until 32.5 months later, assessed every 8 weeks ]

3.  Secondary:

Overall Survival (OS)   [ Time Frame: From randomization of the first patient until 32.5 months later ]

4.  Other Pre-specified:

Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline   [ Time Frame: At Cycle 1 (4 weeks per Cycle)/baseline ]

5.  Other Pre-specified:

FOSI Total Score at Cycle 3   [ Time Frame: At Cycle 3 (4 weeks per Cycle) ]

6.  Other Pre-specified:

Change From Baseline in FOSI Total Score at Cycle 3   [ Time Frame: Baseline and Cycle 3 (4 weeks per Cycle) ]

7.  Other Pre-specified:

FOSI Total Score at Cycle 5   [ Time Frame: At Cycle 5 (4 weeks per Cycle) ]

8.  Other Pre-specified:

Change From Baseline in FOSI Total Score at Cycle 5   [ Time Frame: Baseline and Cycle 5 (4 weeks per Cycle) ]

9.  Other Pre-specified:

FOSI Total Score at End of Treatment   [ Time Frame: At End of treatment (up to Cycle 33, 4 weeks per Cycle) ]

10.  Other Pre-specified:

Change From Baseline in FOSI Total Score at End of Treatment   [ Time Frame: Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) ]

11.  Other Pre-specified:

EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline   [ Time Frame: At Cycle 1 (4 weeks per Cycle)/baseline ]

12.  Other Pre-specified:

EQ-5D Index Score at Cycle 3   [ Time Frame: At Cycle 3 (4 weeks per Cycle) ]

13.  Other Pre-specified:

Change From Baseline in EQ-5D Index Score at Cycle 3   [ Time Frame: Baseline and Cycle 3 (4 weeks per Cycle) ]

14.  Other Pre-specified:

EQ-5D Index Score at Cycle 5   [ Time Frame: At Cycle 5 (4 weeks per Cycle) ]

15.  Other Pre-specified:

Change From Baseline in EQ-5D Index Score at Cycle 5   [ Time Frame: Baseline and Cycle 5 (4 weeks per Cycle) ]

16.  Other Pre-specified:

EQ-5D Index Score at End of Treatment   [ Time Frame: At End of treatment (up to Cycle 33, 4 weeks per Cycle) ]

17.  Other Pre-specified:

Change From Baseline in EQ-5D Index Score at End of Treatment   [ Time Frame: Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) ]

18.  Other Pre-specified:

EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline   [ Time Frame: At Cycle 1 (4 weeks per Cycle)/baseline ]

19.  Other Pre-specified:

EQ-5D VAS Score at Cycle 3   [ Time Frame: At Cycle 3 (4 weeks per Cycle) ]

20.  Other Pre-specified:

Change From Baseline in EQ-5D VAS Score at Cycle 3   [ Time Frame: Baseline and Cycle 3 (4 weeks per Cycle) ]

21.  Other Pre-specified:

EQ-5D VAS Score at Cycle 5   [ Time Frame: At Cycle 5 (4 weeks per Cycle) ]

22.  Other Pre-specified:

Change From Baseline in EQ-5D VAS Score at Cycle 5   [ Time Frame: Baseline and Cycle 5 (4 weeks per Cycle) ]

23.  Other Pre-specified:

EQ-5D VAS Score at End of Treatment   [ Time Frame: At End of treatment (up to Cycle 33, 4 weeks per Cycle) ]

24.  Other Pre-specified:

Change From Baseline in EQ-5D VAS Score at End of Treatment   [ Time Frame: Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) ]