{"commentary":{"count":6,"free_build_floor":8,"listing_floor":3,"by_channel":{"podcast":4,"youtube":2},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"VELIA","nct_id":"NCT02470585","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=velia-nct02470585. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":"VELIA","arms":[{"description":"Participants will receive placebo to veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by placebo monotherapy continuous dosing for an additional thirty 21-day cycles.","label":"Placebo + Carboplatin + Paclitaxel -> Placebo","type":"ACTIVE_COMPARATOR"},{"description":"Participants will receive 150 mg veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by placebo monotherapy continuous dosing for an additional thirty 21-day cycles.","label":"Veliparib + Carboplatin + Paclitaxel -> Placebo","type":"EXPERIMENTAL"},{"description":"Participants will receive 150 mg veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by 300/400 mg veliparib monotherapy orally twice a day for an additional thirty 21-day cycles.","label":"Veliparib + Carboplatin + Paclitaxel -> Veliparib","type":"EXPERIMENTAL"}],"collaborators":["Australia New Zealand Gynaecological Oncology Group"],"completion_date":{"date":"2023-10-05","type":"ACTUAL"},"conditions":["Ovarian Cancer","Ovarian Neoplasm"],"enrollment":{"count":1140,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Veliparib","type":"DRUG"},{"name":"Paclitaxel","type":"DRUG"},{"name":"Carboplatin","type":"DRUG"},{"name":"Placebo to Veliparib","type":"OTHER"}],"last_update":"2024-10-26","lead_sponsor":"AbbVie","official_title":"A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","overall_status":"TERMINATED","phases":["PHASE3"],"primary_completion_date":{"date":"2019-05-03","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1)","timeFrame":"From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months."},{"measure":"Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1)","timeFrame":"From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months."},{"measure":"Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1)","timeFrame":"From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months."}],"references":[{"citation":"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.","pmid":"31562800","type":"BACKGROUND"},{"citation":"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.","pmid":"41565553","type":"DERIVED"},{"citation":"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.","pmid":"34906376","type":"DERIVED"},{"citation":"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.","pmid":"33369580","type":"DERIVED"},{"citation":"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.","pmid":"28665051","type":"DERIVED"}],"start_date":{"date":"2015-07-14","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"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","url":"https://clinicaltrials.gov/study/NCT02470585"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/velia-nct02470585"}