A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel with or without Concurrent and Continuation Maintenance Veliparib (PARP inhibitor) in Newly Diagnosed Subjects with Previously Untreated Stages III or IV High-Grade Serious Epithelial Ovarian,

Grants and Contracts Details

Description

This Phase 3 study is designed to test whether the integration of concurrent and continuation maintenance veliparib (ABT-888), a poly-(ADP-ribose)-polymerase (PARP) inhibitor, with carboplatin/paclitaxel chemotherapy for high grade serous epithelial, ovarian, fallopian tube, or primary peritoneal cancer will improve clinical outcomes. In this context, it is important to recognize that the potential mechanisms of PARP inhibition differ when directly integrated with platinum-based chemotherapy (enhanced cytotoxicity or therapeutic synergy) compared to use as a single agent after completion of chemotherapy (synthetic lethality in tumors with defective homologous deoxyribonucleic acid [DNA] repair). This Phase 3 study incorporates both of these approaches in the experimental arms. While significant strides have been made to tailor the primary treatment of ovarian cancer to improve efficacy and tolerability, the mortality of advanced-stage ovarian cancer has not changed, and additional improvements are needed. The discovery and development of new molecular targeted agents may lead to more effective combination regimens and improved outcomes for patients. Currently, the standard of care for the primary treatment of ovarian, fallopian tube, or primary peritoneal cancer is a combination of platinum and taxane chemotherapy. For patients with early-stage disease, as well as advanced suboptimal Stage III and Stage IV disease, intravenous (IV) carboplatin and paclitaxel is given on an every-3-week (Q3-weeks) cycle for 6 cycles. Weekly administration of paclitaxel has shown a survival benefit compared to every-3-weeks paclitaxel administration for patients with Stage II - IV disease. For Stage II/III patients with small-volume (optimal) residual disease after primary cytoreductive surgery, a regimen combining intraperitoneal (IP) cisplatin and paclitaxel with IV paclitaxel is often used. Despite the majority of patients entering a clinical complete remission following initial cytoreductive surgery and chemotherapy, most recur and eventually develop treatment resistant disease.
StatusActive
Effective start/end date12/23/157/4/23

Funding

  • Gynecological Oncology Group Foundation Incorporated: $137,904.00

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