At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 806 enrolled
Drug / intervention
Olaparib +1 moredrug
Likely dose
Olaparib 300 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.
Randomized, Double-Blind, Phase III Trial Olaparib vs. Placebo Patients With Advanced FIGO Stage IIIB-IV High Grade Serious or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer Treated Standard First-Line Treatment
In Brief
A Phase 3 clinical trial evaluating Olaparib and Placebo for Ovarian Cancer. Completed, enrolled 806 participants across 163 sites in 11 countries.
Detailed Summary
Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
CountriesAustria, Belgium, Denmark, Finland, France, Germany, Italy, Japan, Monaco, Spain, Sweden
CollaboratorsArbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom Germany, Arbeitsgemeinschaft Gynaekologische Onkologie Austria, Grupo Español de Investigación en Cáncer de Ovario, Belgian Gynaecological Oncology Group, Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies, Mario Negri Gynecologic Oncology group (MaNGO), Nordic Society of Gynaecological Oncology - Clinical Trials Unit, Gynecologic Oncology Trial & Investigation Consortium
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMay 2015
First PostedJun 2015
Primary CompletionMar 2019
Study CompletionMar 2022
TodayJul 2026
First PostedJun 23, 2015
Enrollment StartMay 6, 2015
Primary CompletionMar 22, 2019
Study CompletionMar 22, 2022
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 11.0 years ago
Interventions
Olaparibdrug
Tablets, per os, 300 mg twice daily;
Placebodrug
Tablets, per os, 300 mg twice daily.