Trial ID # | NCT00989651; GOG-9923 |
Phase | I |
Drug Class | DNA Damage Repair Pathway Inhibitors: PARP |
Drug Name | Veliparib |
Alternate Drug Names | ABT-888 |
Drugs in Trial | Carboplatin, Cisplatin, Paclitaxel, Veliparib, Bevacizumab |
Eligible Participant | Newly diagnosed stage II-IV ovarian cancer |
Patients Enrolled | 424 stage II-IV ovarian cancer (73.6% stage III) |
Therapy Setting | First-line |
Study Design | Open-Label, Non-randomized |
Endpoints | PFS, OS, evaluated per RECIST |
Efficacy | IV: IV CarboPt+Pac+Bev every 21 days w/ Bev maint (n=173) IV Vel cont vs IV Vel int vs weekly IV Vel cont vs weekly IV Vel int vs IP Vel cont vs IP Vel int: |
Clinically Significant Adverse Events | IV vs weekly IV vs IP: |
Conclusion | Patients receiving IP cisplatin + IV/IP paclitaxel show promising PFS and OS when compared to patients receiving IV carboplatin+paclitaxel, however differences may be reflective of selection bias toward patients enrolled on the IP chemotherapy arm |
Reference | Washington CR et al. Outcomes based on treatment regimen in newly diagnosed ovarian, primary peritoneal and fallopian tube cancer receiving intravenous or intraperitoneal platinum-based chemotherapy in combination with veliparib and bevacizumab. SGO (2020) abstract 27 Gillen J et al. Tolerability and adverse events experienced by women with ovarian cancer treated with intravenous or intraperitoneal chemotherapy plus veliparib and bevacizumab based on BRCA status. SGO (2020) abstract 26 Moore KN et al. A phase I study of intravenous or intraperitoneal platinum based chemotherapy in combination with veliparib and bevacizumab in newly diagnosed ovarian, primary peritoneal and fallopian tube cancer. Gynecol Oncol (2020) 156(1):13-22 |