Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1072 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-12-02
Study Completion Date
2016-06-20
Brief Summary
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The purpose of this study is to compare overall survival in participants with metastatic colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.
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Detailed Description
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Conditions
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Colorectal Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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FOLFIRI + Ramucirumab
Group Type
EXPERIMENTAL
Ramucirumab
Intervention Type
BIOLOGICAL
8 milligrams / kilogram (mg/kg) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
Irinotecan
Intervention Type
DRUG
180 milligrams/square meter (mg/m\^2) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
Folinic Acid
Intervention Type
DRUG
400 mg/m\^2 administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
5-Fluorouracil
Intervention Type
DRUG
400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
FOLFIRI + Placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
BIOLOGICAL
Administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
Irinotecan
Intervention Type
DRUG
180 milligrams/square meter (mg/m\^2) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
Folinic Acid
Intervention Type
DRUG
400 mg/m\^2 administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
5-Fluorouracil
Intervention Type
DRUG
400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
Interventions
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Ramucirumab
8 milligrams / kilogram (mg/kg) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
Intervention Type
BIOLOGICAL
Placebo
Administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
Intervention Type
BIOLOGICAL
Irinotecan
180 milligrams/square meter (mg/m\^2) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
Intervention Type
DRUG
Folinic Acid
400 mg/m\^2 administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
Intervention Type
DRUG
5-Fluorouracil
400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
Intervention Type
DRUG
Other Intervention Names
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LY3009806
IMC-1121B
leucovorin
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed colorectal cancer, excluding primary tumors of appendiceal origin (participants are eligible to enroll irrespective of KRAS mutation status)
* Confirmed metastatic colorectal cancer (Stage IV)
* The participant has received first-line combination therapy of bevacizumab, oxaliplatin, and a fluoropyrimidine for metastatic disease and, a) Experienced radiographic disease progression during first-line therapy, or b) Experienced radiographic disease progression ≤6 months after the last dose of first-line therapy, or c) Discontinued part or all of first-line therapy due to toxicity and experienced radiographic disease progression ≤6 months after the last dose of first-line therapy. Note that a participant must have received a minimum of 2 doses of bevacizumab as part of a first-line regimen containing chemotherapy; in addition, a participant must have received at least 1 cycle of first-line therapy that included bevacizumab, oxaliplatin and a fluoropyrimidine in the same cycle. Note that a participant must not have received more than 2 different fluoropyrimidines as part of a first-line regimen; disease progression is not an acceptable reason for discontinuing 1 fluoropyrimidine and starting a second fluoropyrimidine
* Receipt of no more than 2 prior systemic chemotherapy regimens in any setting (only 1 prior regimen for metastatic disease is permitted). For participants with rectal cancer, sequential neoadjuvant and adjuvant therapy will count as a single systemic regimen. Note that rechallenge with oxaliplatin is permitted and will be considered part of the first-line regimen for metastatic disease, both initial oxaliplatin treatment and subsequent rechallenge are considered as 1 regimen
* Measurable or nonmeasurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Adequate hematologic, renal and hepatic function
* Adequate coagulation function \[International Normalized Ratio (INR) ≤1.5 and Partial Thromboplastin Time (PTT) or activated PTT (aPTT) ≤1.5 x upper limit of normal (ULN)). Participants on full-dose anticoagulation must be on a stable dose of anticoagulant therapy and if on oral anticoagulation, must have an INR ≤3 and have no clinically significant active bleeding or pathological condition that carries a high risk of bleeding
* Consent to provide a historical colorectal cancer tissue sample for assessment of biomarkers and the tumor tissue sample is available
* Ability to provide signed informed consent
* Confirmed metastatic colorectal cancer (Stage IV)
* The participant has received first-line combination therapy of bevacizumab, oxaliplatin, and a fluoropyrimidine for metastatic disease and, a) Experienced radiographic disease progression during first-line therapy, or b) Experienced radiographic disease progression ≤6 months after the last dose of first-line therapy, or c) Discontinued part or all of first-line therapy due to toxicity and experienced radiographic disease progression ≤6 months after the last dose of first-line therapy. Note that a participant must have received a minimum of 2 doses of bevacizumab as part of a first-line regimen containing chemotherapy; in addition, a participant must have received at least 1 cycle of first-line therapy that included bevacizumab, oxaliplatin and a fluoropyrimidine in the same cycle. Note that a participant must not have received more than 2 different fluoropyrimidines as part of a first-line regimen; disease progression is not an acceptable reason for discontinuing 1 fluoropyrimidine and starting a second fluoropyrimidine
* Receipt of no more than 2 prior systemic chemotherapy regimens in any setting (only 1 prior regimen for metastatic disease is permitted). For participants with rectal cancer, sequential neoadjuvant and adjuvant therapy will count as a single systemic regimen. Note that rechallenge with oxaliplatin is permitted and will be considered part of the first-line regimen for metastatic disease, both initial oxaliplatin treatment and subsequent rechallenge are considered as 1 regimen
* Measurable or nonmeasurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Adequate hematologic, renal and hepatic function
* Adequate coagulation function \[International Normalized Ratio (INR) ≤1.5 and Partial Thromboplastin Time (PTT) or activated PTT (aPTT) ≤1.5 x upper limit of normal (ULN)). Participants on full-dose anticoagulation must be on a stable dose of anticoagulant therapy and if on oral anticoagulation, must have an INR ≤3 and have no clinically significant active bleeding or pathological condition that carries a high risk of bleeding
* Consent to provide a historical colorectal cancer tissue sample for assessment of biomarkers and the tumor tissue sample is available
* Ability to provide signed informed consent
Exclusion Criteria
* Receipt of bevacizumab ≤28 days prior to randomization
* Receipt of any investigational therapy for non-oncology clinical indication ≤28 days prior to randomization
* Receipt of any previous systemic therapy, other than a combination of bevacizumab, oxaliplatin, and a fluoropyrimidine, for first-line treatment of metastatic colorectal cancer
* Known leptomeningeal disease or brain metastases or uncontrolled spinal cord compression (currently or in the past)
* Experience of any arterial thrombotic or arterial thromboembolic events, including, but not limited to, myocardial infarction, transient ischemic attack, or cerebrovascular accident, ≤12 months prior to randomization
* Pregnant (confirmed by serum beta human chorionic gonadotropin (ß HCG) test ≤7 days prior to randomization) or lactating
* History of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization
* Acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator
* Grade 3 or higher bleeding event ≤3 months prior to randomization
* Experience of any of the following during first-line therapy with a bevacizumab-containing regimen: an arterial thrombotic/thromboembolic event, Grade 4 hypertension, Grade 3 proteinuria, a Grade 3-4 bleeding event, or bowel perforation
* Known history or clinical evidence of Gilbert's Syndrome, or is known to have any of the following genotypes: UGT1A1\*6/\*6, UGT1A1\*28/\*28, or UGT1A1\*6/\*28
* Known allergy to any of the study treatment components, including any components used in the preparation of ramucirumab, or other contraindication to receive the study treatments
* Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinical meaningful ascites resulting from cirrhosis; Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
* Receipt of any investigational therapy for non-oncology clinical indication ≤28 days prior to randomization
* Receipt of any previous systemic therapy, other than a combination of bevacizumab, oxaliplatin, and a fluoropyrimidine, for first-line treatment of metastatic colorectal cancer
* Known leptomeningeal disease or brain metastases or uncontrolled spinal cord compression (currently or in the past)
* Experience of any arterial thrombotic or arterial thromboembolic events, including, but not limited to, myocardial infarction, transient ischemic attack, or cerebrovascular accident, ≤12 months prior to randomization
* Pregnant (confirmed by serum beta human chorionic gonadotropin (ß HCG) test ≤7 days prior to randomization) or lactating
* History of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization
* Acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator
* Grade 3 or higher bleeding event ≤3 months prior to randomization
* Experience of any of the following during first-line therapy with a bevacizumab-containing regimen: an arterial thrombotic/thromboembolic event, Grade 4 hypertension, Grade 3 proteinuria, a Grade 3-4 bleeding event, or bowel perforation
* Known history or clinical evidence of Gilbert's Syndrome, or is known to have any of the following genotypes: UGT1A1\*6/\*6, UGT1A1\*28/\*28, or UGT1A1\*6/\*28
* Known allergy to any of the study treatment components, including any components used in the preparation of ramucirumab, or other contraindication to receive the study treatments
* Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinical meaningful ascites resulting from cirrhosis; Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
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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Sedona, Arizona, United States
Site Status
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Tucson, Arizona, United States
Site Status
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Fayetteville, Arkansas, United States
Site Status
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Little Rock, Arkansas, United States
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Duarte, California, United States
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Escondido, California, United States
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Fresno, California, United States
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Greenbrae, California, United States
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La Jolla, California, United States
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Rancho Cucamonga, California, United States
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San Diego, California, United States
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Denver, Colorado, United States
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Waterbury, Connecticut, United States
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Boynton Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Port Saint Lucie, Florida, United States
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St. Petersburg, Florida, United States
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Titusville, Florida, United States
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Athens, Georgia, United States
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Augusta, Georgia, United States
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Macon, Georgia, United States
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Marietta, Georgia, United States
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Rome, Georgia, United States
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Thomasville, Georgia, United States
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Honolulu, Hawaii, United States
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Harvey, Illinois, United States
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Peoria, Illinois, United States
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Warrenville, Illinois, United States
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Goshen, Indiana, United States
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Indianapolis, Indiana, United States
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Muncie, Indiana, United States
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Bethesda, Maryland, United States
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Minneapolis, Minnesota, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Las Vegas, Nevada, United States
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Cherry Hill, New Jersey, United States
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Hackensack, New Jersey, United States
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Morristown, New Jersey, United States
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Albuquerque, New Mexico, United States
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Hudson, New York, United States
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Jamaica, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Tulsa, Oklahoma, United States
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Bend, Oregon, United States
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Portland, Oregon, United States
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Kingston, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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Columbia, South Carolina, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Abilene, Texas, United States
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Arlington, Texas, United States
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Beaumont, Texas, United States
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Bedford, Texas, United States
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Dallas, Texas, United States
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Denton, Texas, United States
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Flower Mound, Texas, United States
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Fort Worth, Texas, United States
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Garland, Texas, United States
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McAllen, Texas, United States
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Odessa, Texas, United States
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Paris, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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Sherman, Texas, United States
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Sugar Land, Texas, United States
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Temple, Texas, United States
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The Woodlands, Texas, United States
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Tyler, Texas, United States
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Waco, Texas, United States
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Webster, Texas, United States
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Wichita Falls, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Fairfax, Virginia, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Winchester, Virginia, United States
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Kennewick, Washington, United States
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Seattle, Washington, United States
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Spokane Valley, Washington, United States
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Milwaukee, Wisconsin, 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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Tucumain, , Argentina
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Viedma, , Argentina
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Liverpool, New South Wales, Australia
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Randwick, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Wodonga, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Woolloongabba, Queensland, Australia
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Bedford Park, South Australia, Australia
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Elizabeth Vale, South Australia, Australia
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Innsbruck, , Austria
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Krems, , Austria
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Vienna, , Austria
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Bonheiden, , Belgium
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Brussels, , Belgium
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Charleroi, , Belgium
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Edegem, , Belgium
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Haine-St.- Paul, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Ijuí, , Brazil
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Itajaí, , Brazil
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Rio de Janeiro, , Brazil
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Salvador, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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Brno, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Copenhagen, , Denmark
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Odense, , Denmark
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Helsinki, , Finland
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Tampere, , Finland
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Bordeaux, , France
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La Chaussée-Saint-Victor, , France
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Le Mans, , France
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Nantes, , France
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Paris, , France
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Poitiers, , France
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Strasbourg, , France
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Augsburg, , Germany
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Balingen, , Germany
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Bamberg, , Germany
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Dresden, , Germany
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Frankfurt, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Lübeck, , Germany
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Mönchengladbach, , Germany
Site Status
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Munich, , Germany
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Weiden, , Germany
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Athens, , Greece
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Chania, , Greece
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Ioannina, , Greece
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Budapest, , Hungary
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Kecskemét, , Hungary
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Bangalore, , India
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Kochi, , India
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Kolkata, , India
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New Delhi, , India
Site Status
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Trivandrum, , India
Site Status
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Beersheba, , Israel
Site Status
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Haifa, , Israel
Site Status
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
Site Status
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Genova, , Italy
Site Status
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Livorno, , Italy
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Macerata, , Italy
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Padua, , Italy
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Reggio Emilia, , Italy
Site Status
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Rome, , 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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Gifu, , Japan
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Hokkaido, , Japan
Site Status
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Hyōgo, , Japan
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Kanagawa, , Japan
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Kochi, , Japan
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Osaka, , 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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Breda, , Netherlands
Site Status
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Deventer, , Netherlands
Site Status
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Eindhoven, , Netherlands
Site Status
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Groningen, , Netherlands
Site Status
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Sittard - Geleen, , Netherlands
Site Status
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Coimbra, , Portugal
Site Status
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Porto, , Portugal
Site Status
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Bayamón, , Puerto Rico
Site Status
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Bucharest, , Romania
Site Status
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Cluj-Napoca, , Romania
Site Status
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Iași, , Romania
Site Status
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Oradea, , Romania
Site Status
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Ljubljana, , Slovenia
Site Status
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Anyang, , South Korea
Site Status
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Goyang-si, , South Korea
Site Status
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Incheon, , South Korea
Site Status
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Seoul, , South Korea
Site Status
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Suwon, , South Korea
Site Status
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Barcelona, , Spain
Site Status
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Madrid, , Spain
Site Status
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Oviedo, , Spain
Site Status
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Pamplona, , Spain
Site Status
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Sabadell, , Spain
Site Status
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Seville, , Spain
Site Status
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Valencia, , Spain
Site Status
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Stockholm, , Sweden
Site Status
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Uppsala, , Sweden
Site Status
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Kaohsiung City, , Taiwan
Site Status
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Kuei Shan Hsiang, , Taiwan
Site Status
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Taichung, , Taiwan
Site Status
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Tainan City, , Taiwan
Site Status
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Taipei, , Taiwan
Site Status
Countries
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United States
Argentina
Australia
Austria
Belgium
Brazil
Czechia
Denmark
Finland
France
Germany
Greece
Hungary
India
Israel
Italy
Japan
Netherlands
Portugal
Puerto Rico
Romania
Slovenia
South Korea
Spain
Sweden
Taiwan
References
Explore related publications, articles, or registry entries linked to this study.
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
Taniguchi H, Yoshino T, Yamaguchi K, Yamazaki K, Nixon AB, Tabernero J, Van Cutsem E, Robling KR, Abada PB, Hozak RR, Siegel R, Fill JA, Wijayawardana S, Walgren RA, Giles B, Jones A, Pitts KR, Drove N, Muro K. Clinical development and evaluation of a VEGF-D assay in plasma from patients with metastatic colorectal cancer in the RAISE study. Curr Med Res Opin. 2021 Oct;37(10):1769-1778. doi: 10.1080/03007995.2021.1940908. Epub 2021 Jul 28.
Reference Type
DERIVED
Lim HH, Hopkins AM, Rowland A, Yuen HY, Karapetis CS, Sorich MJ. Effect of Early Adverse Events on Survival Outcomes of Patients with Metastatic Colorectal Cancer Treated with Ramucirumab. Target Oncol. 2019 Dec;14(6):743-748. doi: 10.1007/s11523-019-00683-z.
Reference Type
DERIVED
Yoshino T, Portnoy DC, Obermannova R, Bodoky G, Prausova J, Garcia-Carbonero R, Ciuleanu T, Garcia-Alfonso P, Cohn AL, Van Cutsem E, Yamazaki K, Lonardi S, Muro K, Kim TW, Yamaguchi K, Grothey A, O'Connor J, Taieb J, Wijayawardana SR, Hozak RR, Nasroulah F, Tabernero J. Biomarker analysis beyond angiogenesis: RAS/RAF mutation status, tumour sidedness, and second-line ramucirumab efficacy in patients with metastatic colorectal carcinoma from RAISE-a global phase III study. Ann Oncol. 2019 Jan 1;30(1):124-131. doi: 10.1093/annonc/mdy461.
Reference Type
DERIVED
Grothey A, Yoshino T, Bodoky G, Ciuleanu T, Garcia-Carbonero R, Garcia-Alfonso P, Van Cutsem E, Muro K, Mytelka DS, Li L, Lipkovich O, Hsu Y, Sashegyi A, Ferry D, Nasroulah F, Tabernero J. Association of baseline absolute neutrophil counts and survival in patients with metastatic colorectal cancer treated with second-line antiangiogenic therapies: exploratory analyses of the RAISE trial and validation in an electronic medical record data set. ESMO Open. 2018 Apr 24;3(3):e000347. doi: 10.1136/esmoopen-2018-000347. eCollection 2018.
Reference Type
DERIVED
Tabernero J, Hozak RR, Yoshino T, Cohn AL, Obermannova R, Bodoky G, Garcia-Carbonero R, Ciuleanu TE, Portnoy DC, Prausova J, Muro K, Siegel RW, Konrad RJ, Ouyang H, Melemed SA, Ferry D, Nasroulah F, Van Cutsem E. Analysis of angiogenesis biomarkers for ramucirumab efficacy in patients with metastatic colorectal cancer from RAISE, a global, randomized, double-blind, phase III study. Ann Oncol. 2018 Mar 1;29(3):602-609. doi: 10.1093/annonc/mdx767.
Reference Type
DERIVED
Obermannova R, Van Cutsem E, Yoshino T, Bodoky G, Prausova J, Garcia-Carbonero R, Ciuleanu T, Garcia Alfonso P, Portnoy D, Cohn A, Yamazaki K, Clingan P, Lonardi S, Kim TW, Yang L, Nasroulah F, Tabernero J. Subgroup analysis in RAISE: a randomized, double-blind phase III study of irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) plus ramucirumab or placebo in patients with metastatic colorectal carcinoma progression. Ann Oncol. 2016 Nov;27(11):2082-2090. doi: 10.1093/annonc/mdw402. Epub 2016 Aug 29.
Reference Type
DERIVED
Tabernero J, Yoshino T, Cohn AL, Obermannova R, Bodoky G, Garcia-Carbonero R, Ciuleanu TE, Portnoy DC, Van Cutsem E, Grothey A, Prausova J, Garcia-Alfonso P, Yamazaki K, Clingan PR, Lonardi S, Kim TW, Simms L, Chang SC, Nasroulah F; RAISE Study Investigators. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol. 2015 May;16(5):499-508. doi: 10.1016/S1470-2045(15)70127-0. Epub 2015 Apr 12.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I4T-MC-JVBB
Identifier Type: OTHER
Identifier Source: secondary_id
CP12-0920
Identifier Type: OTHER
Identifier Source: secondary_id
2010-021037-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTRI/2011/07/001900
Identifier Type: REGISTRY
Identifier Source: secondary_id
13856
Identifier Type: -
Identifier Source: org_study_id
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