At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 246 enrolled
Drug / intervention
Sorafenib (Nexavar, BAY43-9006) +1 moredrug
Likely dose
Sorafenib (Nexavar, BAY43-9006) 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006) and Placebo for Ovarian Neoplasms. Completed, enrolled 246 participants across 59 sites in 14 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Neoplasms
CountriesBelgium, Canada, Finland, France, Germany, Hong Kong, Italy, Japan, Netherlands, Poland, Singapore, South Korea, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2008
First PostedNov 2008
Primary CompletionJul 2011
Study CompletionDec 2012
TodayJul 2026
First PostedNov 17, 2008
Enrollment StartNov 1, 2008
Primary CompletionJul 1, 2011
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.6 years ago
Interventions
Sorafenib (Nexavar, BAY43-9006)drug
Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration.
Placebodrug
Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.