Spots Global Cancer Trial Database for Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2
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Trial Identification
Brief Title: Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2
Official Title: A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2
Study ID: NCT04935359
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). This study aims to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel can reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.
Detailed Description: This is a randomized, double-blind, multicenter two-arm, phase III study that has two parts: * Safety run-in part: An open-label safety run-in part will be conducted to confirm recommended phase 3 dose (RP3D) of NIS793 in combination with gemcitabine and nab-paclitaxel. Up to approximately 10 participants will be enrolled at each dose level to achieve at least 6 evaluable participants; however, if the starting dose is not recommended and a lower dose level is tested, 10 additional participants will be enrolled. The decision to open the randomized part will be based on dose confirmation and available safety, relevant PK, and other relevant data from run-in part * Randomized part: Enrolled participants will be randomized to the two treatment arms. The study treatment will be administered as a 28-day treatment cycle. Participants will be treated until unacceptable toxicity, disease progression per RECIST 1.1, withdrawal of consent or any other condition of treatment discontinuation specified in the protocol. Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped. The trial was unblinded and study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Highlands Oncology Group ., Fayetteville, Arkansas, United States
University Of California LA Santa Monica Location, Los Angeles, California, United States
Advent Health Cancer Institute, Orlando, Florida, United States
Fort Wayne Medical Oncology/Hematology, Inc. Jefferson Blvd, Fort Wayne, Indiana, United States
NYU Clinical Cancer Center Dept of NYU Clin CancerCenter, New York, New York, United States
NYU Clinical Cancer Center, New York, New York, United States
US Oncology Research, Dallas ., Dallas, Texas, United States
Houston Methodist Hospital OPC 26, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Novartis Investigative Site, Adelaide, South Australia, Australia
Novartis Investigative Site, Perth, Western Australia, Australia
Novartis Investigative Site, Edegem, Antwerpen, Belgium
Novartis Investigative Site, Bonheiden, , Belgium
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Brasilia, Distrito Federal, Brazil
Novartis Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil
Novartis Investigative Site, Ijuí, RS, Brazil
Novartis Investigative Site, Sao Paulo, SP, Brazil
Novartis Investigative Site, Brampton, Ontario, Canada
Novartis Investigative Site, Cambridge, Ontario, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Harbin, Heilongjiang, China
Novartis Investigative Site, Nanjing, Jiangsu, China
Novartis Investigative Site, Dalian, Liaoning, China
Novartis Investigative Site, Jining, Shandong, China
Novartis Investigative Site, Xian, Shanxi, China
Novartis Investigative Site, Chengdu, Sichuan, China
Novartis Investigative Site, Hangzhou, Zhejiang, China
Novartis Investigative Site, Beijing, , China
Novartis Investigative Site, Beijing, , China
Novartis Investigative Site, Beijing, , China
Novartis Investigative Site, Guangzhou, , China
Novartis Investigative Site, Shanghai, , China
Novartis Investigative Site, Shanghai, , China
Novartis Investigative Site, Shanghai, , China
Novartis Investigative Site, Shanghai, , China
Novartis Investigative Site, Tianjin, , China
Novartis Investigative Site, Brno, Czech Republic, Czechia
Novartis Investigative Site, Novy Jicin, Czech Republic, Czechia
Novartis Investigative Site, Hradec Kralove, CZE, Czechia
Novartis Investigative Site, Praha 4, , Czechia
Novartis Investigative Site, Helsinki, , Finland
Novartis Investigative Site, Tampere, , Finland
Novartis Investigative Site, Nice Cedex 2, Alpes Maritimes, France
Novartis Investigative Site, Besançon, Cedex, France
Novartis Investigative Site, Avignon, , France
Novartis Investigative Site, Creteil, , France
Novartis Investigative Site, Lyon Cedex 08, , France
Novartis Investigative Site, Marseille, , France
Novartis Investigative Site, Montpellier cedex 5, , France
Novartis Investigative Site, Nantes Cedex 1, , France
Novartis Investigative Site, Paris, , France
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Bochum, , Germany
Novartis Investigative Site, Essen, , Germany
Novartis Investigative Site, Frankfurt, , Germany
Novartis Investigative Site, Halle S, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Ulm, , Germany
Novartis Investigative Site, Thessaloniki, , Greece
Novartis Investigative Site, Thessaloniki, , Greece
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Debrecen, , Hungary
Novartis Investigative Site, Jerusalem, , Israel
Novartis Investigative Site, Ramat Gan, , Israel
Novartis Investigative Site, Tel Aviv, , Israel
Novartis Investigative Site, Firenze, FI, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Verona, VR, Italy
Novartis Investigative Site, Nagoya, Aichi, Japan
Novartis Investigative Site, Kashiwa, Chiba, Japan
Novartis Investigative Site, Yokohama-city, Kanagawa, Japan
Novartis Investigative Site, Osaka-city, Osaka, Japan
Novartis Investigative Site, Chuo ku, Tokyo, Japan
Novartis Investigative Site, Koto ku, Tokyo, Japan
Novartis Investigative Site, Seoul, Seocho Gu, Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Utrecht, , Netherlands
Novartis Investigative Site, Nordbyhagen, Oslo, Norway
Novartis Investigative Site, Oslo, , Norway
Novartis Investigative Site, Omsk, , Russian Federation
Novartis Investigative Site, Pushkin Saint Petersburg, , Russian Federation
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Banska Bystrica, , Slovakia
Novartis Investigative Site, Bratislava, , Slovakia
Novartis Investigative Site, Kosice, , Slovakia
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain
Novartis Investigative Site, Santiago De Compostela, Galicia, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Malmo, , Sweden
Novartis Investigative Site, Umea, , Sweden
Novartis Investigative Site, Bellinzona, , Switzerland
Novartis Investigative Site, Geneve 14, , Switzerland
Novartis Investigative Site, St. Gallen, , Switzerland
Novartis Investigative Site, Kuei Shan Chiang, Taoyuan, Taiwan
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Adana, , Turkey
Novartis Investigative Site, Istanbul, , Turkey
Novartis Investigative Site, Izmir, , Turkey
Novartis Investigative Site, Sihhiye / Ankara, , Turkey
Novartis Investigative Site, Sutton, Surrey, United Kingdom
Novartis Investigative Site, Cambridge, , United Kingdom
Novartis Investigative Site, Liverpool, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, Oxford, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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