At a glance
ClinicalIndex Comparison Record- ✓Female patients ≥18 years with histologically confirmed primary advanced invasive high grade non-mucinous, non-clear cell epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer FIGO III/IV (except FIGO stage IIIA2 without nodal involvement)
- ✓Prior upfront primary debulking surgery OR planned chemotherapy with interval debulking surgery
- ✓Tumor samples available for BRCA status determination
- ✓Systemic therapy must commence within 8 weeks of cytoreductive surgery
- ✕Non-epithelial tumor origin of the ovary
- ✕Ovarian tumors of low malignant potential or low grade tumors
- ✕Planned intraperitoneal cytotoxic chemotherapy
- ✕Prior malignancies within 5 years except negligible risk (>90% 5-year OS)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Niraparib vs Niraparib in Combination With Bevacizumab in Patients With Carboplatinum-taxane Based Chemotherapy in Advanced Ovarian Cancer (A Multicentre Randomised Phase III Trial)
In Brief
A Phase 3 clinical trial evaluating Carboplatin, Paclitaxel, and 2 other interventions for Ovarian Cancer and 2 related conditions. Currently recruiting, targeting 970 participants across 65 sites.
Signals
Detailed Summary
This is an international, multicenter, randomized, open, Phase III trial to evaluate the efficacy and safety of carboplatin/paclitaxel/bevacizumab followed by bevacizumab and niraparib compared to carboplatin/paclitaxel followed by niraparib in patients with newly diagnosed advanced ovarian cancer.
Study Details
Timeline
Interventions
Area under curve (AUC) 5, intravenous, on day 1 every 3 weeks for 6 cycles
175 mg/m², intravenous, on day 1 every 3 weeks for 6 cycles
7.5 mg/kg or 15 mg/kg (according to local standard), intravenous, on day 1 every 3 weeks starting from cycle 2 in combination with chemotherapy and thereafter for up to 1 year starting from Cycle 7 Day 1
200 or 300 mg capsules once daily for up to a total of 3 years starting from Cycle 7 Day 1