A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer
NCT ID: NCT02514551
Last Updated: 2020-06-17
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
245 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-10-12
Study Completion Date
2018-12-28
Brief Summary
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The main purpose of this study is to evaluate the efficacy of an alternative dose of ramucirumab in combination with paclitaxel in participants with second-line metastatic or locally advanced, unresectable gastric or gastroesophageal junction adenocarcinoma (GEJ).
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Detailed Description
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Conditions
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Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
12 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 milligram per square meter (mg/m²) paclitaxel administered IV on day 1, day 8 and day 15.
Group Type
EXPERIMENTAL
Ramucirumab
Intervention Type
DRUG
Administered IV
Paclitaxel
Intervention Type
DRUG
Administered IV
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
Group Type
ACTIVE_COMPARATOR
Ramucirumab
Intervention Type
DRUG
Administered IV
Paclitaxel
Intervention Type
DRUG
Administered IV
Interventions
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Ramucirumab
Administered IV
Intervention Type
DRUG
Paclitaxel
Administered IV
Intervention Type
DRUG
Other Intervention Names
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LY3009806
IMC-1121B
Cyramza
Eligibility Criteria
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Inclusion Criteria
* The participant has a diagnosis of gastric or GEJ adenocarcinoma.
* The participant has disease progression during or within 4 months after last dose of first-line chemotherapy or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.
* The participant received combination chemotherapy, which must include a platinum and/or a fluoropyrimidine and must not include a taxane or antiangiogenic agent.
* The disease is evaluable by imaging per Response Evaluation Criteria in Solid Tumors 1.1.
* The participant has an Eastern Cooperative Oncology Group performance status of 0 or 1.
* The participant has adequate organ function:
* Total bilirubin ≤1.5 × the upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN. If the liver has tumor involvement, AST and ALT \<5 × ULN.
* Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥50 milliliters/minute.
* Urinary protein is \<2+.
* Absolute neutrophil count ≥1.5 × 10\^9/liter (L), platelets ≥100 × 10\^9/L, and hemoglobin ≥9 grams/deciliter (5.58 millimoles/L).
* International normalized ratio ≤1.5 × ULN and partial thromboplastin time ≤5 seconds above ULN.
* The participant has an estimated life expectancy of minimum 12 weeks.
* The participant has resolution to Grade 1 or less by Common Terminology Criteria for Adverse Events Version 4.0, of all clinically significant toxic effects of previous therapy.
* The participant, if male, is sterile or agrees to use a reliable method of birth control.
* The participant, if female, is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control.
* The participant, if female and of child-bearing potential, must have a negative pregnancy test.
* The participant has disease progression during or within 4 months after last dose of first-line chemotherapy or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.
* The participant received combination chemotherapy, which must include a platinum and/or a fluoropyrimidine and must not include a taxane or antiangiogenic agent.
* The disease is evaluable by imaging per Response Evaluation Criteria in Solid Tumors 1.1.
* The participant has an Eastern Cooperative Oncology Group performance status of 0 or 1.
* The participant has adequate organ function:
* Total bilirubin ≤1.5 × the upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN. If the liver has tumor involvement, AST and ALT \<5 × ULN.
* Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥50 milliliters/minute.
* Urinary protein is \<2+.
* Absolute neutrophil count ≥1.5 × 10\^9/liter (L), platelets ≥100 × 10\^9/L, and hemoglobin ≥9 grams/deciliter (5.58 millimoles/L).
* International normalized ratio ≤1.5 × ULN and partial thromboplastin time ≤5 seconds above ULN.
* The participant has an estimated life expectancy of minimum 12 weeks.
* The participant has resolution to Grade 1 or less by Common Terminology Criteria for Adverse Events Version 4.0, of all clinically significant toxic effects of previous therapy.
* The participant, if male, is sterile or agrees to use a reliable method of birth control.
* The participant, if female, is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control.
* The participant, if female and of child-bearing potential, must have a negative pregnancy test.
Exclusion Criteria
* The participant is receiving therapy with any of the following:
* Nonsteroidal anti-inflammatory agents.
* Other anti-platelet agents; Aspirin use at doses up to 325 milligrams (mg)/day is permitted.
* The participant received radiotherapy within 14 days prior to randomization.
* The participant received previous chemotherapy with a cumulative dose of \>900 mg per meter squared (mg/m\^2) of epirubicin or \>400 mg/m\^2 of doxorubicin.
* The participant has documented brain metastases or leptomeningeal disease.
* The participant has a significant bleeding disorder or vasculitis.
* The participant experienced any arterial thromboembolic event within 6 months.
* The participant has symptomatic congestive heart failure or symptomatic cardiac arrhythmia.
* The participant has uncontrolled hypertension, despite antihypertensive intervention.
* The participant underwent major surgery within 28 days.
* The participant has a history of gastrointestinal perforation or fistula within 6 months.
* The participant has a history of inflammatory bowel disease or Crohn's disease requiring medical intervention within 12 months.
* The participant has bowel obstruction or history of chronic diarrhea that is considered clinically significant.
* The participant has either of the following:
* Child-pugh B or C cirrhosis.
* The participant has a serious illness or medical condition including:
* Human immunodeficiency virus infection.
* The participant has a concurrent active malignancy other than the following:
* Nonmelanomatous skin cancer.
* In situ carcinoma of the cervix or other noninvasive carcinoma or in situ neoplasm.
* The participant has a serious nonhealing: (a) wound, (b) peptic ulcer, or (c) bone fracture.
* The participant experienced any Grade 3 or 4 venous thromboembolic event that is not adequately treated.
* Nonsteroidal anti-inflammatory agents.
* Other anti-platelet agents; Aspirin use at doses up to 325 milligrams (mg)/day is permitted.
* The participant received radiotherapy within 14 days prior to randomization.
* The participant received previous chemotherapy with a cumulative dose of \>900 mg per meter squared (mg/m\^2) of epirubicin or \>400 mg/m\^2 of doxorubicin.
* The participant has documented brain metastases or leptomeningeal disease.
* The participant has a significant bleeding disorder or vasculitis.
* The participant experienced any arterial thromboembolic event within 6 months.
* The participant has symptomatic congestive heart failure or symptomatic cardiac arrhythmia.
* The participant has uncontrolled hypertension, despite antihypertensive intervention.
* The participant underwent major surgery within 28 days.
* The participant has a history of gastrointestinal perforation or fistula within 6 months.
* The participant has a history of inflammatory bowel disease or Crohn's disease requiring medical intervention within 12 months.
* The participant has bowel obstruction or history of chronic diarrhea that is considered clinically significant.
* The participant has either of the following:
* Child-pugh B or C cirrhosis.
* The participant has a serious illness or medical condition including:
* Human immunodeficiency virus infection.
* The participant has a concurrent active malignancy other than the following:
* Nonmelanomatous skin cancer.
* In situ carcinoma of the cervix or other noninvasive carcinoma or in situ neoplasm.
* The participant has a serious nonhealing: (a) wound, (b) peptic ulcer, or (c) bone fracture.
* The participant experienced any Grade 3 or 4 venous thromboembolic event that is not adequately treated.
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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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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City of Hope National Medical Center
Duarte, California, United States
Site Status
University of Kansas Medical Center
Westwood, Kansas, 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
Montefiore Medical Center
The Bronx, New York, United States
Site Status
Scott & White Memorial Hospital & Clinic
Temple, Texas, United States
Site Status
Vista Oncology Inc. PS
Olympia, Washington, United States
Site Status
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Brussels, , Belgium
Site Status
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Kortrijk, , Belgium
Site Status
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Namur, , Belgium
Site Status
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Calgary, , Canada
Site Status
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Oshawa, , Canada
Site Status
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Brno, , Czechia
Site Status
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Nový Jičín, , Czechia
Site Status
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Prague, , Czechia
Site Status
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Prague, , Czechia
Site Status
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Berlin, , Germany
Site Status
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Frankfurt am Main, , Germany
Site Status
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Hamburg, , Germany
Site Status
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Ravensburg, , Germany
Site Status
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Athens, , Greece
Site Status
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Haidari, , Greece
Site Status
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Heraklion, , Greece
Site Status
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N. Efkarpia, , Greece
Site Status
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Pátrai, , Greece
Site Status
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Cagliari, , Italy
Site Status
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Cremona, , Italy
Site Status
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Faenza, , Italy
Site Status
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Milan, , Italy
Site Status
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Reggio Emilia, , Italy
Site Status
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San Giovanni Rotondo, , Italy
Site Status
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Barcelona, , Spain
Site Status
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Barcelona, , Spain
Site Status
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Girona, , Spain
Site Status
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Madrid, , Spain
Site Status
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Madrid, , Spain
Site Status
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Málaga, , Spain
Site Status
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Santander, , Spain
Site Status
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Seville, , Spain
Site Status
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Valencia, , Spain
Site Status
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Gothenburg, , Sweden
Site Status
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Linköping, , Sweden
Site Status
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Ankara, , Turkey (Türkiye)
Site Status
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Edirne, , Turkey (Türkiye)
Site Status
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Istanbul, , Turkey (Türkiye)
Site Status
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Kayseri, , Turkey (Türkiye)
Site Status
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Malatya, , Turkey (Türkiye)
Site Status
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Dnipropetrovsk, , Ukraine
Site Status
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Kyiv, , Ukraine
Site Status
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Lutsk, , Ukraine
Site Status
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Sumy, , Ukraine
Site Status
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Vinnitsa, , Ukraine
Site Status
Countries
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United States
Belgium
Canada
Czechia
Germany
Greece
Italy
Spain
Sweden
Turkey (Türkiye)
Ukraine
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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http://www.lillytrialguide.com/EN-us/studies/cancer/jvcz
Click here for more information about this study: A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer
Other Identifiers
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I4T-MC-JVCZ
Identifier Type: OTHER
Identifier Source: secondary_id
2014-005067-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15541
Identifier Type: -
Identifier Source: org_study_id
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