Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Clear Cell Carcinoma
- Fallopian Tube Cancer
- Ovarian Cancer
- Primary Peritoneal Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
The main scope of this trial is to determine progression free survival in patients treated with Rucaparib as maintenance therapy vs. Placebo after receiving Bevacizumab for 12 to 15 months. Patients will be stratified according to time point of surgery (adjuvant vs. neoadjuvant), result of surgery (...
The main scope of this trial is to determine progression free survival in patients treated with Rucaparib as maintenance therapy vs. Placebo after receiving Bevacizumab for 12 to 15 months. Patients will be stratified according to time point of surgery (adjuvant vs. neoadjuvant), result of surgery (tumor free vs. not tumor free resection), study site and response (complete response (CR) vs. partial response (PR)/SD) and randomized 2:1 to receive either Rucaparib (Arm A) or Placebo (Arm B). In both of the arms, tumor assessments (CT or MRI) are performed before randomization, and every 12 weeks thereafter. During treatment, clinical visits (blood cell counts, detection of toxicity) occur every 4 weeks. Physical examinations and tumor assessments will take place every 12 weeks. Safety will be monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs). About 30 sites in Germany will participate in this study to recruit 190 patients in 24 months.
Tracking Information
- NCT #
- NCT04227522
- Collaborators
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Clovis Oncology, Inc.
- Investigators
- Principal Investigator: Jalid Sehouli, Prof. Dr. Charité-Universitätsmedizin Berlin Campus Virchow-Klinikum
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