A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer
NCT ID: NCT02314117
Last Updated: 2021-08-26
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
645 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-01-20
Study Completion Date
2020-08-14
Brief Summary
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The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.
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Detailed Description
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Conditions
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Metastatic Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Ramucirumab + Cisplatin + Capecitabine
8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m\^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m\^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m\^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Group Type
EXPERIMENTAL
Ramucirumab
Intervention Type
DRUG
Administered IV
Capecitabine
Intervention Type
DRUG
Administered orally
Cisplatin
Intervention Type
DRUG
Administered IV
Fluorouracil
Intervention Type
DRUG
Administered IV
Placebo + Cisplatin + Capecitabine
Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m\^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m\^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m\^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
Group Type
ACTIVE_COMPARATOR
Capecitabine
Intervention Type
DRUG
Administered orally
Cisplatin
Intervention Type
DRUG
Administered IV
Placebo
Intervention Type
DRUG
Administered IV
Fluorouracil
Intervention Type
DRUG
Administered IV
Interventions
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Ramucirumab
Administered IV
Intervention Type
DRUG
Capecitabine
Administered orally
Intervention Type
DRUG
Cisplatin
Administered IV
Intervention Type
DRUG
Placebo
Administered IV
Intervention Type
DRUG
Fluorouracil
Administered IV
Intervention Type
DRUG
Other Intervention Names
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LY3009806
IMC-1121B
Cyramza
Eligibility Criteria
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Inclusion Criteria
* Have a histopathologically confirmed diagnosis of metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. All histologies of nonsquamous cell origin including undifferentiated gastric carcinoma are eligible.
* Have not received any prior first-line systemic therapy (prior adjuvant or neo-adjuvant therapy is permitted). Participants whose disease has progressed after \>12 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
* Have measurable or nonmeasurable but evaluable disease determined using guidelines in Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1). Baseline tumor assessment should be performed using a high resolution computed tomography (CT) scan using IV and oral contrast unless clinically contra-indicated. Magnetic resonance imaging (MRI) is acceptable if a CT cannot be performed.
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale at baseline.
* Have adequate organ function.
* Have baseline clinical and laboratory parameters that are consistent with the requirements prescribed in respective labels and are suitable for consideration of treatment with capecitabine (or 5-FU) and cisplatin (for example, dihydropyrimidine dehydrogenase deficiency).
* Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator.
* Have not received any prior first-line systemic therapy (prior adjuvant or neo-adjuvant therapy is permitted). Participants whose disease has progressed after \>12 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
* Have measurable or nonmeasurable but evaluable disease determined using guidelines in Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1). Baseline tumor assessment should be performed using a high resolution computed tomography (CT) scan using IV and oral contrast unless clinically contra-indicated. Magnetic resonance imaging (MRI) is acceptable if a CT cannot be performed.
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale at baseline.
* Have adequate organ function.
* Have baseline clinical and laboratory parameters that are consistent with the requirements prescribed in respective labels and are suitable for consideration of treatment with capecitabine (or 5-FU) and cisplatin (for example, dihydropyrimidine dehydrogenase deficiency).
* Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator.
Exclusion Criteria
* Participants with adenocarcinoma of the esophagus are excluded.
* Participants with human epidermal growth factor receptor 2 (HER2)-positive status.
* Participants receiving chronic therapy with nonsteroidal anti-inflammatory agents.
* Have radiation therapy within 14 days prior to randomization.
* Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord compression.
* Have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to randomization.
* Have experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
* Have symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
* Have uncontrolled hypertension prior to initiating study treatment, despite antihypertensive intervention.
* Have undergone major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to first dose of study treatment, except if the procedure is minimally invasive (for example, introduction of peripherally inserted central catheter \[PICC\] line) and the investigator does not anticipate any significant bleeding.
* Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
* Have a history of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization.
* Have an acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator.
* The participant has:
* cirrhosis at a level of Child-Pugh B (or worse) or
* cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
* Have known allergy or hypersensitivity to any components of study treatment.
* Are pregnant or lactating.
* Participants with human epidermal growth factor receptor 2 (HER2)-positive status.
* Participants receiving chronic therapy with nonsteroidal anti-inflammatory agents.
* Have radiation therapy within 14 days prior to randomization.
* Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord compression.
* Have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to randomization.
* Have experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
* Have symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
* Have uncontrolled hypertension prior to initiating study treatment, despite antihypertensive intervention.
* Have undergone major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to first dose of study treatment, except if the procedure is minimally invasive (for example, introduction of peripherally inserted central catheter \[PICC\] line) and the investigator does not anticipate any significant bleeding.
* Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
* Have a history of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization.
* Have an acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator.
* The participant has:
* cirrhosis at a level of Child-Pugh B (or worse) or
* cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
* Have known allergy or hypersensitivity to any components of study treatment.
* Are pregnant or lactating.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
Site Status
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Site Status
St Jude Medical Center
Fullerton, California, United States
Site Status
SMO TRIO -Translational Research
Los Angeles, California, United States
Site Status
UCLA Medical Center
Los Angeles, California, United States
Site Status
Cancer Care Associates Medical Group
Redondo Beach, California, United States
Site Status
Coastal Integrative Cancer Care
San Luis Obispo, California, United States
Site Status
Central Coast Medical Oncology Corporation
Santa Monica, California, United States
Site Status
University of Colorado School of Medicine
Aurora, Colorado, United States
Site Status
Yale University School of Medicine
New Haven, Connecticut, United States
Site Status
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, United States
Site Status
Florida Cancer Specialists
Fort Myers, Florida, United States
Site Status
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida, United States
Site Status
Emory University
Atlanta, Georgia, United States
Site Status
Illinois CancerCare
Peoria, Illinois, United States
Site Status
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Site Status
Weill Cornell Medical College
New York, New York, United States
Site Status
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Site Status
Oncology Hematology Care Inc
Cincinnati, Ohio, United States
Site Status
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Site Status
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Site Status
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, United States
Site Status
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Site Status
UT Southwestern Med Ctr
Dallas, Texas, United States
Site Status
Baylor College of Medicine
Houston, Texas, United States
Site Status
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Viedma, Río Negro Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Ciudad Autonoma Buenos Aires, , Argentina
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La Rioja, , Argentina
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Rosario, , Argentina
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Salta, , Argentina
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Brussels, , Belgium
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Charleroi, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Montreal, , Canada
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Montreal, , Canada
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Ottawa, , Canada
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Toronto, , Canada
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Toronto, , Canada
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Toronto, , Canada
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Toronto, , Canada
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Vancouver, , Canada
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Brno, , Czechia
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Aalborg, , Denmark
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Aarhus C, , Denmark
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Odense C, , Denmark
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Helsinki, , Finland
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Oulu, , Finland
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Turku, , Finland
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Avignon, , France
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Clermont-Ferrand, , France
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Lille, , France
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Paris, , France
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Saint-Etienne, , France
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Saint-Herblain, , France
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Villejuif, , France
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Dresden, , Germany
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Frankfurt am Main, , Germany
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Hamburg, , Germany
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Mannheim, , Germany
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München, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Gyula, , Hungary
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Kaposvár, , Hungary
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Szolnok, , Hungary
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Haifa, , 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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Florence, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Pisa, , Italy
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Roma, , Italy
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Torrette Di Ancona, , Italy
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Udine, , Italy
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Chiba, , Japan
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Fukuoka, , Japan
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Higashinari-Ku, , Japan
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Kashiwa, , Japan
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Kitaadachi-Gun, , Japan
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Kobe, , Japan
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Kōtoku, , Japan
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Nagoya, , Japan
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Osaka, , Japan
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Suita-shi, , Japan
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Sunto-Gun, , Japan
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Utsunomiya, , Japan
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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San Bernardino, Toluca, Mexico
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Juchitán, , Mexico
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Mexico City, , Mexico
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Mérida, , Mexico
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México, , Mexico
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Oaxaca City, , Mexico
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Breda, , Netherlands
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Nieuwegein, , Netherlands
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Sittard - Geleen, , Netherlands
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Gdansk, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Warsaw, , Poland
Site Status
Ad-Vance Medical Research
Ponce, , Puerto Rico
Site Status
Hospital Espanol Auxilio Mutuo
San Juan, , Puerto Rico
Site Status
VA Caribbean Healthcare System
San Juan, , Puerto Rico
Site Status
Hospital Municipal de San Juan
San Juan, , Puerto Rico
Site Status
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Arkhangelsk, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Barcelona, , Spain
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Barcelona, , Spain
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Elche, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Aberdeen, , United Kingdom
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Cambridge, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Merseyside, , United Kingdom
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Nottingham, , United Kingdom
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Sheffield, , United Kingdom
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Sutton, , United Kingdom
Site Status
Countries
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United States
Argentina
Belgium
Canada
Czechia
Denmark
Finland
France
Germany
Hungary
Israel
Italy
Japan
Mexico
Netherlands
Poland
Puerto Rico
Russia
Spain
United Kingdom
References
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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.
Reference Type
DERIVED
Fuchs CS, Shitara K, Di Bartolomeo M, Lonardi S, Al-Batran SE, Van Cutsem E, Ilson DH, Alsina M, Chau I, Lacy J, Ducreux M, Mendez GA, Alavez AM, Takahari D, Mansoor W, Enzinger PC, Gorbounova V, Wainberg ZA, Hegewisch-Becker S, Ferry D, Lin J, Carlesi R, Das M, Shah MA; RAINFALL Study Group. Ramucirumab with cisplatin and fluoropyrimidine as first-line therapy in patients with metastatic gastric or junctional adenocarcinoma (RAINFALL): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):420-435. doi: 10.1016/S1470-2045(18)30791-5. Epub 2019 Feb 1.
Reference Type
DERIVED
Related Links
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https://trials.lillytrialguide.com/en-US/trial/kPN4NxC5uCCu4eG6MMGeI?conditionId=B6nAiYh98OCsos8uoOISQ
A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer
Other Identifiers
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I4T-MC-JVCU
Identifier Type: OTHER
Identifier Source: secondary_id
2014-002240-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15372
Identifier Type: -
Identifier Source: org_study_id
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