A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma
NCT ID: NCT01170663
Last Updated: 2019-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
665 participants
INTERVENTIONAL
2010-12-31
2017-02-28
Brief Summary
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Detailed Description
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Approximately 663 participants (at least 18 years) in approximately 200 study centers and in approximately 30 countries will be randomized with histologically or cytologically confirmed metastatic gastric or gastroesophageal junction adenocarcinoma. Participants must have received at least one cycle of first line therapy with any platinum/fluoropyrimidine doublet with or without anthracycline (epirubicin or doxorubicin) and must have discontinued this therapy prior to study entry due to disease progression.
Upon registration and completion of screening procedure and reviewing the Inclusion and Exclusion Criteria eligible participants will be randomized to receive either paclitaxel plus ramucirumab or paclitaxel plus placebo.
Ramucirumab (IMC-1211B) DP/placebo will be administered IV on Days 1 and 15, paclitaxel will be administered IV on Days 1, 8 and 15 of a 4 weekly cycle.
Participants will be continuously treated and monitored until radiographic or symptomatic progression of disease, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ramucirumab (IMC-1211B) Drug Product (DP) and Paclitaxel
Ramucirumab (IMC-1211B) DP and Paclitaxel
Ramucirumab (IMC-1211B) DP
8 milligrams/kilogram (mg/kg) intravenous (IV) infusion on Days 1 and 15 of every 4-week cycle
Paclitaxel
Paclitaxel 80 milligrams per square meter (mg/m²) IV infusion on Days 1, 8, and 15 of every 4-week cycle
Placebo and Paclitaxel
Placebo and Paclitaxel
Placebo
Ramucirumab placebo IV infusion on Days 1 and 15 of every 4-week cycle
Paclitaxel
Paclitaxel 80 milligrams per square meter (mg/m²) IV infusion on Days 1, 8, and 15 of every 4-week cycle
Interventions
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Ramucirumab (IMC-1211B) DP
8 milligrams/kilogram (mg/kg) intravenous (IV) infusion on Days 1 and 15 of every 4-week cycle
Placebo
Ramucirumab placebo IV infusion on Days 1 and 15 of every 4-week cycle
Paclitaxel
Paclitaxel 80 milligrams per square meter (mg/m²) IV infusion on Days 1, 8, and 15 of every 4-week cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
* Metastatic disease or locally advanced, unresectable disease
* Disease progression during or within 4 months after the last dose of the first-line therapy (platinum/fluoropyrimidine doublet with or without anthracycline)
* Organs are functioning well (liver, kidney, blood)
* Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1
Exclusion Criteria
* Previous systemic therapy with other anti-angiogenic drugs
* Uncontrolled high blood pressure
* Symptomatic or poorly controlled heart disease or had a heart attack or stroke within the last 6 month
* Evidence of central nervous system (CNS) metastasis at baseline
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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ImClone Investigational Site
Burbank, California, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Jacksonville, Florida, United States
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Miramar, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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East Orange, New Jersey, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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Chattanooga, Tennessee, United States
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Houston, Texas, United States
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Seattle, Washington, United States
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Buenos Aires, , Argentina
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Caba, , Argentina
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Rosario, , Argentina
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Santa Fe, , Argentina
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Bankstown, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Liverpool, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Southport, Queensland, Australia
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Kurralta Park, South Australia, Australia
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Coburg, Victoria, Australia
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Footscray, Victoria, Australia
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Frankston, Victoria, Australia
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Parkville, Victoria, Australia
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Graz, , Austria
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Linz, , Austria
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Steyr, , Austria
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Vienna, , Austria
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Bonheiden, , Belgium
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Bruges, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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Belo Horizonte, , Brazil
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Belo Horizonte, , Brazil
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Caxias do Sul, , Brazil
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Dois Lajeados, , Brazil
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Gávea, , Brazil
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Ijuí, , Brazil
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Itajaí, , Brazil
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Londrina, , Brazil
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Passo Fundo, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre-Rs, , Brazil
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Ribeirão Preto, , Brazil
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Rio de Janeiro, , Brazil
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Salvador, , Brazil
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Sao Jose Rio Preto, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Sorocaba, , Brazil
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Providencia, , Chile
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Viña del Mar, , Chile
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Tallinn, , Estonia
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Tallinn, , Estonia
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Besançon, , France
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Brest, , France
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Clermont-Ferrand, , France
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Marseille, , France
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Montbéliard, , France
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Montpellier, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Saint-Etienne, , France
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Berlin, , Germany
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Bielefeld, , Germany
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Dresden, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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Munich, , Germany
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Recklinghausen, , Germany
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Tübingen, , Germany
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Budapest, , Hungary
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Gyula, , Hungary
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Kaposvár, , Hungary
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Pécs, , Hungary
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Székesfehérvár, , Hungary
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Beersheba, , Israel
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Haifa, , Israel
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Holon, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Ancona, , Italy
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Bari, , Italy
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Bergamo, , Italy
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Catania, , Italy
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Genova, , Italy
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Milan, , Italy
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Padua, , Italy
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Pisa, , Italy
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Torino, , Italy
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Aichi, , Japan
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Chiba, , Japan
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Ehime, , Japan
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Fukuoka, , Japan
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Hokkaido, , Japan
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Kochi, , Japan
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Osaka, , Japan
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Osaka-Pref, , Japan
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Ōita, , Japan
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Saitama, , Japan
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Shizuoka, , Japan
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Tochigi, , Japan
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Tokyo, , Japan
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Juchitán, , Mexico
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Nuevo León, , Mexico
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Brzozów, , Poland
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Aveiro, , Portugal
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Coimbra, , Portugal
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Evora, , Portugal
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Porto, , Portugal
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Santa Maria da Feira, , Portugal
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Baia Mare, , Romania
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Bucharest, , Romania
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Iași, , Romania
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Târgu Mureş, , Romania
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Krasnodar, , Russia
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Moscow, , Russia
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Perm, , Russia
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Saint Petersburg, , Russia
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Ufa, , Russia
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Singapore, , Singapore
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Incheon, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Suwon, , South Korea
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Ávila, , Spain
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Burgos, , Spain
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Jerez de la Frontera, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Palma de Mallorca, , Spain
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Sabadell, , Spain
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Seville, , Spain
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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Liouying/Tainan, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Maidstone, Kent, United Kingdom
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Guildford, Surrey, United Kingdom
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Sutton, Surrey, United Kingdom
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Wolverhampton, West Midlands, United Kingdom
Countries
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References
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Ogata T, Narita Y, Wainberg ZA, Van Cutsem E, Yamaguchi K, Piao Y, Zhao Y, Peterson PM, Wijayawardana SR, Abada P, Chatterjee A, Muro K. Exploratory Analysis of Patients With Gastric/Gastroesophageal Junction Adenocarcinoma With or Without Liver Metastasis From the Phase 3 RAINBOW Study. J Gastric Cancer. 2023 Apr;23(2):289-302. doi: 10.5230/jgc.2023.23.e15.
Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.
Yamaguchi K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Omuro Y, Tamura T, Piao Y, Homma G, Jen MH, Liepa AM, Muro K. Quality of Life Associated with Ramucirumab Treatment in Patients with Advanced Gastric Cancer in Japan: Exploratory Analysis from the Phase III RAINBOW Trial. Clin Drug Investig. 2021 Jan;41(1):53-64. doi: 10.1007/s40261-020-00979-3. Epub 2020 Dec 23.
Cascinu S, Bodoky G, Muro K, Van Cutsem E, Oh SC, Folprecht G, Ananda S, Girotto G, Wainberg ZA, Miron MLL, Ajani J, Wei R, Liepa AM, Carlesi R, Emig M, Ohtsu A. Tumor Response and Symptom Palliation from RAINBOW, a Phase III Trial of Ramucirumab Plus Paclitaxel in Previously Treated Advanced Gastric Cancer. Oncologist. 2021 Mar;26(3):e414-e424. doi: 10.1002/onco.13623. Epub 2020 Dec 23.
De Vita F, Borg C, Farina G, Geva R, Carton I, Cuku H, Wei R, Muro K. Ramucirumab and paclitaxel in patients with gastric cancer and prior trastuzumab: subgroup analysis from RAINBOW study. Future Oncol. 2019 Aug;15(23):2723-2731. doi: 10.2217/fon-2019-0243. Epub 2019 Jun 25.
Chau I, Fuchs CS, Ohtsu A, Barzi A, Liepa AM, Cui ZL, Hsu Y, Al-Batran SE. Association of quality of life with disease characteristics and treatment outcomes in patients with advanced gastric cancer: Exploratory analysis of RAINBOW and REGARD phase III trials. Eur J Cancer. 2019 Jan;107:115-123. doi: 10.1016/j.ejca.2018.11.013. Epub 2018 Dec 14.
Tabernero J, Ohtsu A, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Ajani JA, Tomasek J, Safran H, Chandrawansa K, Hsu Y, Heathman M, Khan A, Ni L, Melemed AS, Gao L, Ferry D, Fuchs CS. Exposure-Response Analyses of Ramucirumab from Two Randomized, Phase III Trials of Second-line Treatment for Advanced Gastric or Gastroesophageal Junction Cancer. Mol Cancer Ther. 2017 Oct;16(10):2215-2222. doi: 10.1158/1535-7163.MCT-16-0895. Epub 2017 Jul 17.
Al-Batran SE, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov ON, Kim TY, Cunningham D, Rougier P, Muro K, Liepa AM, Chandrawansa K, Emig M, Ohtsu A, Wilke H. Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. Ann Oncol. 2016 Apr;27(4):673-9. doi: 10.1093/annonc/mdv625. Epub 2016 Jan 7.
Shitara K, Muro K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Yamaguchi K, Segawa Y, Omuro Y, Tamura T, Doi T, Yukisawa S, Yasui H, Nagashima F, Gotoh M, Esaki T, Emig M, Chandrawansa K, Liepa AM, Wilke H, Ichimiya Y, Ohtsu A. Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer. Gastric Cancer. 2016 Jul;19(3):927-38. doi: 10.1007/s10120-015-0559-z. Epub 2015 Oct 28.
Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.
Other Identifiers
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I4T-IE-JVBE
Identifier Type: OTHER
Identifier Source: secondary_id
CP12-0922
Identifier Type: OTHER
Identifier Source: secondary_id
2010-020426-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13894
Identifier Type: -
Identifier Source: org_study_id
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