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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00791778
First received: November 14, 2008
Last updated: March 1, 2013
Last verified: March 2013
Results First Received: November 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Ovarian Neoplasms
Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)
Drug: Placebo

  Participant Flow
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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  
[1] includes: 40 subjects with progression, 18 subjects ongoing with treatment
[2] includes: 71 subjects with progression, 32 subjects ongoing with treatment

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  
[1] All randomized patients (excluding 18 ongoing on treatment) entered follow up period
[2] All randomized patients (excluding 32 ongoing on treatment) entered follow up period
[3] Ongoing with survival follow-up



  Baseline Characteristics
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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.
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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
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] Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst).
[2] Patients were to have either ovarian epithelial cancer or primary peritoneal cancer. Primary peritoneal carcinoma involves the extra-ovarian peritoneum significantly and the ovarian surface minimally or not at all.
[3] The presence or absence of any IP chemotherapy before enrollment into the study.
[4] The degree of residual disease following initial diagnosis and surgical debulkment: optimal surgical cytoreduction (any/each lesion remaining after surgery ≤1 cm) or suboptimal surgical cytoreduction (any/each lesion remaining after surgery >1cm)



  Outcome Measures
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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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided by Bayer

Publications automatically indexed to this study:

Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00791778     History of Changes
Other Study ID Numbers: 12007, 2008-004429-41
Study First Received: November 14, 2008
Results First Received: November 1, 2012
Last Updated: March 1, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Italy: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
South Korea: Korea Food and Drug Administration (KFDA)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Ministry of Health
Singapore: Health Sciences Authority
Spain: Ministry of Health