Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
With
Part 1: This is a single-centre, phase 1a, open-label, dose-escalation study to evaluate the safety and tolerability of bevacizumab-niraparib combination and determine the RP2D in patients with platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer. The standard 3+3 design will be used. Part 2: (n=94) This multicenter, prospective, open-label, randomized phase 2 study is evaluating the efficacy of niraparib against niraparib-bevacizumab combination in Women with platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer. Stratification: Patients are stratified according to: 1. HRD status (positive/negative) 2. Treatment-Free interval to prior therapy (6-12 months \> 12 months) Randomization: 1:1 randomization Study arms: Patients are randomized to one of the two treatment arms: Arm 1: Niraparib monotherapy until progression. Arm 2: Niraparib-bevacizumab combination therapy until progression.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
