Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Summary
The primary objective of the study was to evaluate whether progression-free survival (PFS) was prolonged with the addition of veliparib to standard platinum-based chemotherapy (carboplatin/paclitaxel \[C/P\]) and continued as maintenance therapy compared with chemotherapy alone.
Timeline
- Start
- 2015-07-14
- Primary completion
- 2019-05-03
- Completion
- 2023-10-05
Outcome
Met primary endpoint
Stopped (Business): “Business decision not related to patient safety”
registry analysis (superiority test); Placebo + Carboplatin + Paclitaxel -> Placebo vs Veliparib + Carboplatin + Paclitaxel -> Veliparib; p <0.001; Hazard Ratio (HR) 0.435 (95% CI 0.277 to 0.683); NCT02470585 ↗
registry analysis (superiority test); Placebo + Carboplatin + Paclitaxel -> Placebo vs Veliparib + Carboplatin + Paclitaxel -> Veliparib; p <0.001; Hazard Ratio (HR) 0.572 (95% CI 0.433 to 0.756); NCT02470585 ↗
registry analysis (superiority test); Placebo + Carboplatin + Paclitaxel -> Placebo vs Veliparib + Carboplatin + Paclitaxel -> Veliparib; p <0.001; Hazard Ratio (HR) 0.683 (95% CI 0.562 to 0.831); NCT02470585 ↗
Publications
- Background Coleman RL, Fleming GF, Brady MF, Swisher EM, Steffensen KD, Friedlander M, Okamoto A, Moore KN, Efrat Ben-Baruch N, Werner TL, Cloven NG, Oaknin A, DiSilvestro PA, Morgan MA, Nam JH, Leath CA 3rd, Nicum S, Hagemann AR, Littell RD, Cella D, Baron-Hay S, Garcia-Donas J, Mizuno M, Bell-McGuinn K, Sullivan DM, Bach BA, Bhattacharya S, Ratajczak CK, Ansell PJ, Dinh MH, Aghajanian C, Bookman MA. Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2403-2415. doi: 10.1056/NEJMoa1909707. Epub 2019 Sep 28.
- Lafferty J, Secord AA, Bookman M, Coleman RL, Dinh MH, Khandelwal N, Kamalakar R, Cella D. Quality-adjusted progression-free survival analysis of veliparib and carboplatin/paclitaxel compared with chemotherapy alone in patients with newly diagnosed ovarian cancer (VELIA/GOG3005): ancillary analysis of a placebo-controlled, phase 3 randomized trial. Int J Gynecol Cancer. 2026 May;36(5):102819. doi: 10.1016/j.ijgc.2025.102819. Epub 2025 Nov 21.
- Swisher EM, Aghajanian C, O'Malley DM, Fleming GF, Kaufmann SH, Levine DA, Birrer MJ, Moore KN, Spirtos NM, Shahin MS, Reid TJ, Friedlander M, Steffensen KD, Okamoto A, Sehgal V, Ansell PJ, Dinh MH, Bookman MA, Coleman RL. Impact of homologous recombination status and responses with veliparib combined with first-line chemotherapy in ovarian cancer in the Phase 3 VELIA/GOG-3005 study. Gynecol Oncol. 2022 Feb;164(2):245-253. doi: 10.1016/j.ygyno.2021.12.003. Epub 2021 Dec 11.
- Washington CR, Moore KN. PARP inhibitors in the treatment of ovarian cancer: a review. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):1-6. doi: 10.1097/GCO.0000000000000675.
- Nishikawa T, Matsumoto K, Tamura K, Yoshida H, Imai Y, Miyasaka A, Onoe T, Yamaguchi S, Shimizu C, Yonemori K, Shimoi T, Yunokawa M, Xiong H, Nuthalapati S, Hashiba H, Kiriyama T, Leahy T, Komarnitsky P, Fujiwara K. Phase 1 dose-escalation study of single-agent veliparib in Japanese patients with advanced solid tumors. Cancer Sci. 2017 Sep;108(9):1834-1842. doi: 10.1111/cas.13307. Epub 2017 Aug 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Veliparib | Small molecule | 300 mg | Oral |
| Subject | Veliparib | Small molecule | 400 mg | Oral |
| Background | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |