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Brief Title: Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)
Official Title: A Double-blind, Randomised, Placebo Controlled Phase III Study of Nintedanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Therapies.
Study ID: NCT02149108
Brief Summary: The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
1199.52.0108 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States
1199.52.0105 Boehringer Ingelheim Investigational Site, New Haven, Connecticut, United States
1199.52.0101 Boehringer Ingelheim Investigational Site, Plainville, Connecticut, United States
1199.52.0121 Boehringer Ingelheim Investigational Site, Arlington Heights, Illinois, United States
1199.52.0123 Boehringer Ingelheim Investigational Site, Sioux City, Iowa, United States
1199.52.0104 Boehringer Ingelheim Investigational Site, Topeka, Kansas, United States
1199.52.0114 Boehringer Ingelheim Investigational Site, New Orleans, Louisiana, United States
1199.52.0113 Boehringer Ingelheim Investigational Site, Detroit, Michigan, United States
1199.52.0125 Boehringer Ingelheim Investigational Site, Omaha, Nebraska, United States
1199.52.0119 Boehringer Ingelheim Investigational Site, Johnson City, New York, United States
1199.52.0115 Boehringer Ingelheim Investigational Site, Canton, Ohio, United States
1199.52.0106 Boehringer Ingelheim Investigational Site, Sylvania, Ohio, United States
1199.52.0102 Boehringer Ingelheim Investigational Site, Nashville, Tennessee, United States
1199.52.0120 Boehringer Ingelheim Investigational Site, Fort Worth, Texas, United States
1199.52.5404 Boehringer Ingelheim Investigational Site, Cdad. de Córdoba, , Argentina
1199.52.5405 Boehringer Ingelheim Investigational Site, Cdad. de Córdoba, , Argentina
1199.52.5401 Boehringer Ingelheim Investigational Site, Ciudad Autónoma de Bs As, , Argentina
1199.52.5403 Boehringer Ingelheim Investigational Site, Ciudad Autónoma de Bs As, , Argentina
1199.52.5406 Boehringer Ingelheim Investigational Site, Ciudad Autónoma de Bs As, , Argentina
1199.52.6102 Boehringer Ingelheim Investigational Site, Concord, New South Wales, Australia
1199.52.6103 Boehringer Ingelheim Investigational Site, St Leonards, New South Wales, Australia
1199.52.6101 Boehringer Ingelheim Investigational Site, Wollongong, New South Wales, Australia
1199.52.6104 Boehringer Ingelheim Investigational Site, Heidelberg, Victoria, Australia
1199.52.6105 Boehringer Ingelheim Investigational Site, Nedlands, Western Australia, Australia
1199.52.6106 Boehringer Ingelheim Investigational Site, Perth, Western Australia, Australia
1199.52.4302 Boehringer Ingelheim Investigational Site, Linz, , Austria
1199.52.4303 Boehringer Ingelheim Investigational Site, Wien, , Austria
1199.52.4304 Boehringer Ingelheim Investigational Site, Wien, , Austria
1199.52.3208 Boehringer Ingelheim Investigational Site, Aalst, , Belgium
1199.52.3205 Boehringer Ingelheim Investigational Site, Bonheiden, , Belgium
1199.52.3202 Boehringer Ingelheim Investigational Site, Bruxelles, , Belgium
1199.52.3207 Boehringer Ingelheim Investigational Site, Charleroi, , Belgium
1199.52.3204 Boehringer Ingelheim Investigational Site, Edegem, , Belgium
1199.52.3203 Boehringer Ingelheim Investigational Site, Haine-Saint-Paul, , Belgium
1199.52.3201 Boehringer Ingelheim Investigational Site, Leuven, , Belgium
1199.52.3206 Boehringer Ingelheim Investigational Site, Liège, , Belgium
1199.52.3521 Boehringer Ingelheim Investigational Site, Luxembourg, , Belgium
1199.52.1003 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada
1199.52.1004 Boehringer Ingelheim Investigational Site, Edmonton, Ontario, Canada
1199.52.1001 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada
1199.52.1002 Boehringer Ingelheim Investigational Site, Montreal, Quebec, Canada
1199.52.4202 Boehringer Ingelheim Investigational Site, Brno, , Czechia
1199.52.4204 Boehringer Ingelheim Investigational Site, Hradec Kralove, , Czechia
1199.52.4201 Boehringer Ingelheim Investigational Site, Prague, , Czechia
1199.52.4502 Boehringer Ingelheim Investigational Site, Herning, , Denmark
1199.52.4501 Boehringer Ingelheim Investigational Site, København Ø, , Denmark
1199.52.4503 Boehringer Ingelheim Investigational Site, Næstved, , Denmark
1199.52.4504 Boehringer Ingelheim Investigational Site, Odense C, , Denmark
1199.52.3304 Boehringer Ingelheim Investigational Site, Lille cedex, , France
1199.52.3307 Boehringer Ingelheim Investigational Site, Lyon cedex 8, , France
1199.52.3305 Boehringer Ingelheim Investigational Site, Paris cedex 15, , France
1199.52.3301 Boehringer Ingelheim Investigational Site, Reims Cedex, , France
1199.52.4906 Boehringer Ingelheim Investigational Site, Dresden, , Germany
1199.52.4905 Boehringer Ingelheim Investigational Site, Essen, , Germany
1199.52.4904 Boehringer Ingelheim Investigational Site, Freiburg, , Germany
1199.52.4903 Boehringer Ingelheim Investigational Site, Mannheim, , Germany
1199.52.4901 Boehringer Ingelheim Investigational Site, Ulm, , Germany
1199.52.8501 Boehringer Ingelheim Investigational Site, Hong Kong, , Hong Kong
1199.52.8502 Boehringer Ingelheim Investigational Site, Hong Kong, , Hong Kong
1199.52.8503 Boehringer Ingelheim Investigational Site, Hong Kong, , Hong Kong
1199.52.8504 Boehringer Ingelheim Investigational Site, Hong Kong, , Hong Kong
1199.52.9706 Boehringer Ingelheim Investigational Site, Beer Sheva, , Israel
1199.52.9704 Boehringer Ingelheim Investigational Site, Petach Tikva, , Israel
1199.52.9703 Boehringer Ingelheim Investigational Site, Tel Aviv, , Israel
1199.52.3901 Boehringer Ingelheim Investigational Site, Genova, , Italy
1199.52.3906 Boehringer Ingelheim Investigational Site, Milano, , Italy
1199.52.3907 Boehringer Ingelheim Investigational Site, Napoli, , Italy
1199.52.3905 Boehringer Ingelheim Investigational Site, Padova, , Italy
1199.52.3903 Boehringer Ingelheim Investigational Site, Pisa, , Italy
1199.52.3904 Boehringer Ingelheim Investigational Site, San Giovanni Rotondo (FG), , Italy
1199.52.8102 Boehringer Ingelheim Investigational Site, Aichi, Nagoya, , Japan
1199.52.8105 Boehringer Ingelheim Investigational Site, Chiba, Chiba, , Japan
1199.52.8101 Boehringer Ingelheim Investigational Site, Chiba, Kashiwa, , Japan
1199.52.8107 Boehringer Ingelheim Investigational Site, Ehime, Matsuyama, , Japan
1199.52.8106 Boehringer Ingelheim Investigational Site, Fukuoka, Fukuoka, , Japan
1199.52.8108 Boehringer Ingelheim Investigational Site, Hokkaido, Sapporo, , Japan
1199.52.8115 Boehringer Ingelheim Investigational Site, Hyogo, Amagasaki, , Japan
1199.52.8112 Boehringer Ingelheim Investigational Site, Hyogo, Kobe, , Japan
1199.52.8114 Boehringer Ingelheim Investigational Site, Ibaraki, Tsukuba, , Japan
1199.52.8110 Boehringer Ingelheim Investigational Site, Oita, Yufu, , Japan
1199.52.8116 Boehringer Ingelheim Investigational Site, Osaka, Osaka, , Japan
1199.52.8103 Boehringer Ingelheim Investigational Site, Osaka, Suita, , Japan
1199.52.8109 Boehringer Ingelheim Investigational Site, Saitama, Kitaadachi-gun, , Japan
1199.52.8104 Boehringer Ingelheim Investigational Site, Shizuoka, Sunto-gun, , Japan
1199.52.8113 Boehringer Ingelheim Investigational Site, Tokyo , Shinagawa-ku, , Japan
1199.52.8111 Boehringer Ingelheim Investigational Site, Tokyo, Koto-ku, , Japan
1199.52.8202 Boehringer Ingelheim Investigational Site, Goyang, , Korea, Republic of
1199.52.8201 Boehringer Ingelheim Investigational Site, Seoul, , Korea, Republic of
1199.52.8203 Boehringer Ingelheim Investigational Site, Seoul, , Korea, Republic of
1199.52.8204 Boehringer Ingelheim Investigational Site, Seoul, , Korea, Republic of
1199.52.5201 Boehringer Ingelheim Investigational Site, Mexico, , Mexico
1199.52.3101 Boehringer Ingelheim Investigational Site, Amsterdam, , Netherlands
1199.52.3103 Boehringer Ingelheim Investigational Site, Amsterdam, , Netherlands
1199.52.3102 Boehringer Ingelheim Investigational Site, Utrecht, , Netherlands
1199.52.4801 Boehringer Ingelheim Investigational Site, Jelenia Gora, , Poland
1199.52.4803 Boehringer Ingelheim Investigational Site, Poznan, , Poland
1199.52.4804 Boehringer Ingelheim Investigational Site, Wroclaw, , Poland
1199.52.3504 Boehringer Ingelheim Investigational Site, Almada, , Portugal
1199.52.3502 Boehringer Ingelheim Investigational Site, Coimbra, , Portugal
1199.52.3505 Boehringer Ingelheim Investigational Site, Loures, , Portugal
1199.52.3501 Boehringer Ingelheim Investigational Site, Porto, , Portugal
1199.52.3506 Boehringer Ingelheim Investigational Site, Porto, , Portugal
1199.52.0701 Boehringer Ingelheim Investigational Site, Moscow, , Russian Federation
1199.52.0703 Boehringer Ingelheim Investigational Site, Moscow, , Russian Federation
1199.52.0702 Boehringer Ingelheim Investigational Site, St. Petersburg, , Russian Federation
1199.52.0707 Boehringer Ingelheim Investigational Site, Tyumen, , Russian Federation
1199.52.3401 Boehringer Ingelheim Investigational Site, Barcelona, , Spain
1199.52.3402 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat, , Spain
1199.52.3406 Boehringer Ingelheim Investigational Site, La Coruña, , Spain
1199.52.3403 Boehringer Ingelheim Investigational Site, Madrid, , Spain
1199.52.3404 Boehringer Ingelheim Investigational Site, Madrid, , Spain
1199.52.3405 Boehringer Ingelheim Investigational Site, Santander, , Spain
1199.52.3407 Boehringer Ingelheim Investigational Site, Sevilla, , Spain
1199.52.4601 Boehringer Ingelheim Investigational Site, Stockholm, , Sweden
1199.52.4602 Boehringer Ingelheim Investigational Site, Uppsala, , Sweden
1199.52.8805 Boehringer Ingelheim Investigational Site, Kaohsiung, , Taiwan
1199.52.8801 Boehringer Ingelheim Investigational Site, Taipei, , Taiwan
1199.52.8803 Boehringer Ingelheim Investigational Site, Taipei, , Taiwan
1199.52.8802 Boehringer Ingelheim Investigational Site, Taoyuan County, , Taiwan
1199.52.9005 Boehringer Ingelheim Investigational Site, Adana, , Turkey
1199.52.9001 Boehringer Ingelheim Investigational Site, Ankara, , Turkey
1199.52.9003 Boehringer Ingelheim Investigational Site, Antalya, , Turkey
1199.52.9004 Boehringer Ingelheim Investigational Site, Istanbul, , Turkey
1199.52.9002 Boehringer Ingelheim Investigational Site, Izmir, , Turkey
1199.52.4401 Boehringer Ingelheim Investigational Site, Aberdeen, , United Kingdom
1199.52.4403 Boehringer Ingelheim Investigational Site, Manchester, , United Kingdom
1199.52.4402 Boehringer Ingelheim Investigational Site, Middlesex, , United Kingdom
1199.52.4405 Boehringer Ingelheim Investigational Site, Nottingham, , United Kingdom
1199.52.4404 Boehringer Ingelheim Investigational Site, Southampton, , United Kingdom
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR