NCT00791778

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

A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients Who Have Achieved a Complete Clinical Response After Standard Platinum/Taxane Containing Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.

Conditions

• Ovarian Neoplasms

Interventions

Type	Name	Description
DRUG	Sorafenib (Nexavar, BAY43-9006)	Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration.
DRUG	Placebo	Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-07-01
• Completion: 2012-12-01
• First posted: 2008-11-17
• Last updated: 2015-09-28
• Results posted: 2012-11-30

Locations

59 sites across 14 countries: United States, Belgium, Canada, Finland, France, Germany, Hong Kong, Italy, Japan, Netherlands, Poland, Singapore, South Korea, Spain