Spots Global Cancer Trial Database for Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer
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Trial Identification
Brief Title: Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma
Study ID: NCT05254171
Study Description
Brief Summary: The study is a randomized, double-blind, placebo-controlled, multicenter study of standard treatment with nab-paclitaxel and gemcitabine with or without SBP-101 in subjects previously untreated for metastatic pancreatic ductal adenocarcinoma (PDA), including subjects who have received prior neoadjuvant or adjuvant treatment.
Detailed Description: This trial will enroll approximately 600 patients to evaluate the effect of SBP-101 on Overall Survival when administered with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel and a placebo. Secondary endpoints include Progression-free survival, radiologic responses to treatment, and Quality of Life measures. An independent, external Data Safety Monitoring Board (DSMB) will monitor safety and efficacy and a planned futility analysis.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Genesis Cancer and Blood Institute (SCRI), Hot Springs, Arkansas, United States
Providence Medical Foundation, Fullerton, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Henry Ford Health System, Detroit, Michigan, United States
CentraCare Health, Saint Cloud, Minnesota, United States
Columbia University Medical Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
Mark H Zangmeister Center - SCRI - PPDS, Columbus, Ohio, United States
Tennessee Oncology NASH - SCRI - PPDS, Nashville, Tennessee, United States
HOPE Cancer Center of East Texas, Tyler, Texas, United States
Medical Oncology Associates - Spokane, Spokane, Washington, United States
MultiCare Regional Cancer Center - Tacoma, Tacoma, Washington, United States
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Canberra Region Cancer Centre, Garran, Australia Capital Territory, Australia
The Tweed Hospital, Tweed Heads, New South Wales, Australia
Ashford Cancer Centre Research, Kurralta Park, South Australia, Australia
Austin Hospital, Heidelberg, Victoria, Australia
St John of God Murdoch Hospital, Murdoch, Western Australia, Australia
Klinikum Klagenfurt Am Woerthersee, Klagenfurt am Wörthersee, Kärnten, Austria
Universitätsklinikum St. Pölten, Sankt Pölten, Niederösterreich, Austria
Ordensklinikum Linz, Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H, Linz, Oberösterreich, Austria
Pyhrn-Eisenwurzen Klinikum Steyr, Steyr, Oberösterreich, Austria
Klinikum Wels-Grieskirchen GmbH, Wels, Oberösterreich, Austria
Landeskrankenhaus Feldkirch, Rankweil, Vorarlberg, Austria
Kepler Universitätsklinikum Linz, Linz, , Austria
Salzburg Cancer Research Institute, Salzburg, , Austria
A.ö. Krankenhaus der Barmherzigen Brüder, Wein, , Austria
Landesklinikum Wiener Neustadt, Wiener Neustadt, , Austria
Imelda VZW, Bonheiden, Antwerpen, Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, Belgique, Belgium
Hôpital de Jolimont, La Louvière, Hainaut, Belgium
Centre Hospitalier de l'Ardenne, Libramont, Luxembourg, Belgium
CHU UCL Namur asbl - Site Godinne, Yvoir, Namur, Belgium
Onze-Lieve-Vrouwziekenhuis, Aalst, Oost-Vlaanderen, Belgium
UZ Gent, Gent, Oost-Vlaanderen, Belgium
AZ Groeninge, Kortrijk, West-Vlaanderen, Belgium
Grand Hopital de Charleroi asbl, Charleroi, , Belgium
UZ Leuven, Leuven, , Belgium
CHU de Liège, Liège, , Belgium
Hopitaux de La Timone, Marseille, Bouches-du-Rhône, France
Centre François Baclesse, Caen, Calvados, France
Hopital Jean Minjoz, Besançon, Doubs, France
Hôpital de Rangueil, Toulouse, Haute-Garonne, France
EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS, Rennes, Ille-et-Vilaine, France
Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden, Sachsen, Germany
Charité - Universitätsmedizin Berlin, Berlin, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Universitätsklinikum Tübingen, Tuebingen, , Germany
Klinikum Weiden, Weiden, , Germany
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS, Meldola, Emilia-Romagna, Italy
Azienda Unita Sanita Locale di Reggio Emilia IRCCS, Reggio Emilia, Emilia-Romagna, Italy
Ospedale San Raffaele S.r.l. - PPDS, Milano, Lombardia, Italy
Instituto Europeo Di Oncologia, Milano, Lombardia, Italy
Ospedale degli Infermi, Candiolo, Piemonte, Italy
Ospedale Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo, Puglia, Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, Toscana, Italy
Ospedale Santa Maria Della Misericordia Di Perugia, Terni, Umbria, Italy
Azienda Ospedaliera Universitaria Integrata Di Verona, Verona, Venito, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia-Vialle Camillo Golgi 19, Pavia, , Italy
National Cancer Center, Seoul, Gyeonggido, Korea, Republic of
CHA Bundang Medical Center, CHA University, Seoul, Gyeonggido, Korea, Republic of
Seoul National University Hospital, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Severance Hospital Yonsei University Health System - PPDS, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, , Korea, Republic of
Asan Medical Center - PPDS, Seoul, , Korea, Republic of
Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain
Hospital Universitario de Jaen, Jaén, Jaen, Spain
Hospital Universitario HM Sanchinarro - CIOCC, Madrid, Madrid, Communidad Delaware, Spain
Hospital de La Santa Creu i Sant Pau, Barcelona, Madrid, Spain
Hospital Universitario Virgen de La Arrixaca, El Palmar, Murcia, Spain
Clinica Universidad Navarra, Pamplona, Navarra, Spain
Hospital Universitario de Navarra, Pamplona, Navarra, Spain
Hospital Universitario Cruces, Barakaldo, Vizcaya, Spain
Hospital Universitario A Coruña, A Coruña, , Spain
Hospital Universitario de Badajoz, Badajoz, , Spain
Hospital Universitario Vall d'Hebron - PPDS, Barcelona, , Spain
ICO l'Hospitalet - Hospital Duran i Reynals, Barcelona, , Spain
Institut Catala d'Oncologia Girona, Girona, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
MD Anderson Cancer Center Madrid - España, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz - PPDS, Madrid, , Spain
Hospital Regional Universitario de Malaga - Hospital General, Málaga, , Spain
Hospital Universitario Virgen del Rocio - PPDS, Sevilla, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Aberdeen Royal Infirmary - PPDS, Aberdeen, Aberdeen City, United Kingdom
Hammersmith Hospital, London, City Of London, United Kingdom
Derriford Hospital, Plympton, Devon, United Kingdom
Contact Details
Name: Michael J Walker, MD
Affiliation: Panbela Therapeutics, Inc.
Role: STUDY_DIRECTOR
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