{"preliminary_commentary":{"by_channel":{"x_thread":44,"youtube":2,"podcast":2},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT01964430\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["nab-paclitaxel"]],"indication":"resected pancreatic ductal adenocarcinoma","name":"APACT","nct_id":"NCT01964430","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=apact-nct01964430. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"apact","arms":[{"description":"Participants received nab-Paclitaxel 125 mg/m\\^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m\\^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.","label":"nab-Paclitaxel 125 mg/m^2 plus gemcitabine 1000 mg/m2","type":"EXPERIMENTAL"},{"description":"Participants received gemcitabine 1000 mg/m\\^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.","label":"Gemcitabine 1000 mg/m^2","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2022-06-30","type":"ACTUAL"},"conditions":["Pancreatic Neoplasms","Digestive System Neoplasms","Neoplasms by Site","Neoplasms","Endocrine Gland Neoplasms","Pancreatic Diseases","Digestive System Diseases","Endocrine System Diseases","Gemcitabine","Antimetabolites, Antineoplastic"],"enrollment":{"count":866,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"nab-Paclitaxel","otherNames":["Abraxane"],"type":"DRUG"},{"name":"Gemcitabine","otherNames":["Gemzar"],"type":"DRUG"}],"last_update":"2023-06-28","lead_sponsor":"Celgene","official_title":"A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-06-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee","timeFrame":"Date of randomization up to data cut off date of 31 December 2018; median DFS follow-up time for censored participants was 22.242 months for nab-Paclitaxel and gemcitabine and 13.832 months for gemcitabine alone"}],"references":[{"citation":"Young R, Mainwaring P, Clingan P, Parnis FX, Asghari G, Beale P, Aly A, Botteman M, Romano A, Ferrara S, Margunato-Debay S, Harris M. nab-Paclitaxel plus gemcitabine in metastatic pancreatic adenocarcinoma: Australian subset analyses of the phase III MPACT trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e325-e331. doi: 10.1111/ajco.12999. Epub 2018 Jun 22.","pmid":"29932294","type":"BACKGROUND"},{"citation":"Reni M, Zanon S, Balzano G, Passoni P, Pircher C, Chiaravalli M, Fugazza C, Ceraulo D, Nicoletti R, Arcidiacono PG, Macchini M, Peretti U, Castoldi R, Doglioni C, Falconi M, Partelli S, Gianni L. A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma. Eur J Cancer. 2018 Oct;102:95-102. doi: 10.1016/j.ejca.2018.07.007. Epub 2018 Aug 24.","pmid":"30149366","type":"BACKGROUND"},{"citation":"Fernandez A, Salgado M, Garcia A, Buxo E, Vera R, Adeva J, Jimenez-Fonseca P, Quintero G, Llorca C, Canabate M, Lopez LJ, Munoz A, Ramirez P, Gonzalez P, Lopez C, Reboredo M, Gallardo E, Sanchez-Canovas M, Gallego J, Guillen C, Ruiz-Miravet N, Navarro-Perez V, De la Camara J, Ales-Diaz I, Pazo-Cid RA, Carmona-Bayonas A. Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study. BMC Cancer. 2018 Nov 29;18(1):1185. doi: 10.1186/s12885-018-5101-3.","pmid":"30497432","type":"BACKGROUND"},{"citation":"Sonbol MB, Ahn DH, Goldstein D, Okusaka T, Tabernero J, Macarulla T, Reni M, Li CP, O'Neil B, Van Cutsem E, Bekaii-Saab T. CanStem111P trial: a Phase III study of napabucasin plus nab-paclitaxel with gemcitabine. Future Oncol. 2019 Apr;15(12):1295-1302. doi: 10.2217/fon-2018-0903. Epub 2019 Feb 15.","pmid":"30768369","type":"BACKGROUND"},{"citation":"Tempero MA, Pelzer U, O'Reilly EM, Winter J, Oh DY, Li CP, Tortora G, Chang HM, Lopez CD, Bekaii-Saab T, Ko AH, Santoro A, Park JO, Noel MS, Frassineti GL, Shan YS, Dean A, Riess H, Van Cutsem E, Berlin J, Philip P, Moore M, Goldstein D, Tabernero J, Li M, Ferrara S, Le Bruchec Y, Zhang G, Lu B, Biankin AV, Reni M; APACT Investigators. Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2023 Apr 10;41(11):2007-2019. doi: 10.1200/JCO.22.01134. Epub 2022 Dec 15.","pmid":"36521097","type":"DERIVED"},{"citation":"Reni M, Braverman J, Hendifar A, Li CP, Macarulla T, Oh DY, Riess H, Tempero M, Lu B, Marcus J, Joshi N, Botteman M, Dueck AC. Evaluation of Minimal Important Difference and Responder Definition in the EORTC QLQ-PAN26 Module for Assessing Health-Related Quality of Life in Patients with Surgically Resected Pancreatic Adenocarcinoma. Ann Surg Oncol. 2021 Nov;28(12):7545-7554. doi: 10.1245/s10434-021-09816-z. Epub 2021 Apr 3.","pmid":"33813673","type":"DERIVED"}],"start_date":{"date":"2014-03-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the \"Apact\" Study)","url":"https://clinicaltrials.gov/study/NCT01964430"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/apact-nct01964430"}