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A Study in Second Line Metastatic Colorectal Cancer

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01183780
Collaborator
(none)
1,072
Enrollment
213
Locations
2
Arms
66.6
Actual Duration (Months)
5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1072 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine
Actual Study Start Date :
Dec 2, 2010
Actual Primary Completion Date :
Jul 17, 2014
Actual Study Completion Date :
Jun 20, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: FOLFIRI + Ramucirumab

Biological: 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
Other Names:
  • LY3009806
  • IMC-1121B

    • Drug: 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

    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
    Other Names:
  • leucovorin

    • 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
    Placebo Comparator: FOLFIRI + Placebo

    Biological: Placebo
    Administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision

    Drug: 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

    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
    Other Names:
  • leucovorin

    • 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

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) [Randomization to Date of Death from Any Cause Up to 39.36 Months]

      OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive.

    Secondary Outcome Measures

    1. Progression-free Survival (PFS) Time [Randomization to Measured PD or Date of Death from Any Cause Up to 38.01 Months]

      PFS was defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) [according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1] or death due to any cause, whichever was first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment.

    2. Percentage of Participants Achieving an Objective Response (Objective Response Rate) [Randomization until Disease Progression Up to 38.01 Months]

      The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Response was defined using RECIST, v. 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameter.

    3. Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status [Baseline Up to 171 Weeks]

      The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Maximum improvement is the best post-baseline change.

    4. Change From Baseline in EuroQol- 5D (EQ-5D) [Baseline and 30-Day Follow-Up (FU) up to 171 Weeks]

      The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.

    5. Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies [Cycles 1, 3, 5, and 30-Day FU]

      Blood samples were tested to determine if a participant reacted to ramucirumab by producing anti-ramucirumab antibodies. Samples were identified as treatment emergent anti-drug antibody (TE ADA) if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)*100.

    6. Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab [Preinfusion and 1 hour postinfusion in Cycles 3, 5, 9, 13, and 17]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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, UGT1A128/28, or UGT1A16/*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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sedona Arizona United States 86336
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tucson Arizona United States 85715
    3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fayetteville Arkansas United States 72703
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Little Rock Arkansas United States 72205
    5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Duarte California United States 91010
    6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Escondido California United States 92025
    7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fresno California United States 93720
    8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Greenbrae California United States 94904
    9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. La Jolla California United States 92093
    10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rancho Cucamonga California United States 91730
    11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Diego California United States 92108
    12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Denver Colorado United States 80218
    13 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Waterbury Connecticut United States 06708
    14 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Boynton Beach Florida United States 33426
    15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fort Lauderdale Florida United States 33308
    16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fort Myers Florida United States 33916
    17 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Miami Florida United States 33176
    18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ocala Florida United States 34471
    19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Port Saint Lucie Florida United States 34952
    20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saint Petersburg Florida United States 33705
    21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Titusville Florida United States 32796
    22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Athens Georgia United States 30607
    23 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Augusta Georgia United States 30901
    24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Macon Georgia United States 31201
    25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Marietta Georgia United States 30060
    26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rome Georgia United States 30165
    27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Thomasville Georgia United States 31792
    28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Honolulu Hawaii United States 96819
    29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Harvey Illinois United States 60426
    30 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Peoria Illinois United States 61615
    31 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Warrenville Illinois United States 60555
    32 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Goshen Indiana United States 46526
    33 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Indianapolis Indiana United States 46237
    34 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Muncie Indiana United States 47303
    35 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bethesda Maryland United States 20817
    36 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Minneapolis Minnesota United States 55404
    37 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Columbia Missouri United States 65201
    38 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saint Louis Missouri United States 63110
    39 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Billings Montana United States 59101
    40 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Las Vegas Nevada United States 89169
    41 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cherry Hill New Jersey United States 08003
    42 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hackensack New Jersey United States 07601
    43 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Morristown New Jersey United States 07962
    44 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Albuquerque New Mexico United States 87109
    45 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bronx New York United States 10467
    46 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hudson New York United States 12534
    47 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jamaica New York United States 11432
    48 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New York New York United States 10029
    49 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Raleigh North Carolina United States 27607
    50 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cincinnati Ohio United States 45242
    51 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Columbus Ohio United States 43219
    52 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tulsa Oklahoma United States 74136
    53 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bend Oregon United States 97701
    54 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Portland Oregon United States 97227
    55 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kingston Pennsylvania United States 18704
    56 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Philadelphia Pennsylvania United States 19106
    57 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Willow Grove Pennsylvania United States 19090
    58 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Columbia South Carolina United States 29210
    59 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Memphis Tennessee United States 38138
    60 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nashville Tennessee United States 37203
    61 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Abilene Texas United States 79606
    62 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Arlington Texas United States 76014
    63 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Beaumont Texas United States 77702
    64 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bedford Texas United States 76022
    65 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dallas Texas United States 75246
    66 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Denton Texas United States 76210
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    169 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chiba Japan 277 8577
    170 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ehime Japan 790-0007
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    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01183780
    Other Study ID Numbers:
    • 13856
    • I4T-MC-JVBB
    • CP12-0920
    • 2010-021037-32
    • CTRI/2011/07/001900
    First Posted:
    Aug 18, 2010
    Last Update Posted:
    Sep 25, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Eli Lilly and Company
    second line
    metastatic colorectal cancer
    FOLFIRI
    ramucirumab
    CRC
    mCRC
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Leucovorin
    Folic Acid
    Fluorouracil
    Irinotecan
    Ramucirumab
    Levoleucovorin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Completers included participants who died from any cause and participants who were alive and on study at conclusion however were off treatment.
    Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI
    Arm/Group Description On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil (FOLFIRI). Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 milligrams/kilogram (mg/kg) administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion. On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.
    Period Title: Overall Study
    STARTED 536 536
    Received at Least 1 Dose of Study Drug 528 529
    COMPLETED 505 511
    NOT COMPLETED 31 25

    Baseline Characteristics

    Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI Total
    Arm/Group Description On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion. On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion. Total of all reporting groups
    Overall Participants 536 536 1072
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    324
    60.4%
    321
    59.9%
    645
    60.2%
    >=65 years
    212
    39.6%
    215
    40.1%
    427
    39.8%
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    62.0
    62.0
    62.0
    Sex: Female, Male (Count of Participants)
    Female
    247
    46.1%
    210
    39.2%
    457
    42.6%
    Male
    289
    53.9%
    326
    60.8%
    615
    57.4%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    38
    7.1%
    39
    7.3%
    77
    7.2%
    Not Hispanic or Latino
    248
    46.3%
    221
    41.2%
    469
    43.8%
    Unknown or Not Reported
    250
    46.6%
    276
    51.5%
    526
    49.1%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    1
    0.2%
    1
    0.1%
    Asian
    111
    20.7%
    103
    19.2%
    214
    20%
    Native Hawaiian or Other Pacific Islander
    1
    0.2%
    1
    0.2%
    2
    0.2%
    Black or African American
    14
    2.6%
    16
    3%
    30
    2.8%
    White
    405
    75.6%
    410
    76.5%
    815
    76%
    More than one race
    3
    0.6%
    0
    0%
    3
    0.3%
    Unknown or Not Reported
    2
    0.4%
    5
    0.9%
    7
    0.7%
    Region of Enrollment (Count of Participants)
    United States
    141
    26.3%
    142
    26.5%
    283
    26.4%
    Portugal
    2
    0.4%
    2
    0.4%
    4
    0.4%
    Taiwan
    5
    0.9%
    6
    1.1%
    11
    1%
    Greece
    8
    1.5%
    8
    1.5%
    16
    1.5%
    Spain
    51
    9.5%
    60
    11.2%
    111
    10.4%
    Israel
    7
    1.3%
    7
    1.3%
    14
    1.3%
    Italy
    17
    3.2%
    20
    3.7%
    37
    3.5%
    India
    1
    0.2%
    2
    0.4%
    3
    0.3%
    France
    12
    2.2%
    15
    2.8%
    27
    2.5%
    Puerto Rico
    2
    0.4%
    1
    0.2%
    3
    0.3%
    Australia
    16
    3%
    19
    3.5%
    35
    3.3%
    Denmark
    3
    0.6%
    8
    1.5%
    11
    1%
    Netherlands
    9
    1.7%
    5
    0.9%
    14
    1.3%
    Korea, Republic of
    22
    4.1%
    25
    4.7%
    47
    4.4%
    Finland
    9
    1.7%
    3
    0.6%
    12
    1.1%
    Austria
    6
    1.1%
    12
    2.2%
    18
    1.7%
    Czech Republic
    40
    7.5%
    37
    6.9%
    77
    7.2%
    Hungary
    24
    4.5%
    23
    4.3%
    47
    4.4%
    Argentina
    7
    1.3%
    11
    2.1%
    18
    1.7%
    Belgium
    30
    5.6%
    22
    4.1%
    52
    4.9%
    Brazil
    2
    0.4%
    3
    0.6%
    5
    0.5%
    Romania
    19
    3.5%
    14
    2.6%
    33
    3.1%
    Germany
    19
    3.5%
    25
    4.7%
    44
    4.1%
    Japan
    74
    13.8%
    62
    11.6%
    136
    12.7%
    Sweden
    10
    1.9%
    4
    0.7%
    14
    1.3%

    Outcome Measures

    1. Primary Outcome
    Title Overall Survival (OS)
    Description OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive.
    Time Frame Randomization to Date of Death from Any Cause Up to 39.36 Months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. Participants censored: Ramucirumab + FOLFIRI group = 164; Placebo + FOLFIRI= 139.
    Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI
    Arm/Group Description On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion. On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.
    Measure Participants 536 536
    Median (95% Confidence Interval) [months]
    13.3
    11.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ramucirumab + FOLFIRI, Placebo + FOLFIRI
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0219
    Comments
    Method Log Rank
    Comments The analysis was performed on stratified data.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.844
    Confidence Interval (2-Sided) 95%
    0.730 to 0.976
    Parameter Dispersion Type:
    Value:
    Estimation Comments The estimation was performed on stratified data.
    2. Secondary Outcome
    Title Progression-free Survival (PFS) Time
    Description PFS was defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) [according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1] or death due to any cause, whichever was first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment.
    Time Frame Randomization to Measured PD or Date of Death from Any Cause Up to 38.01 Months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. Participants censored: Ramucirumab + FOLFIRI = 60; Placebo + FOLFIRI = 42.
    Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI
    Arm/Group Description On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion. On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.
    Measure Participants 536 536
    Median (95% Confidence Interval) [months]
    5.7
    4.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ramucirumab + FOLFIRI, Placebo + FOLFIRI
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments
    Method Log Rank
    Comments Analysis was performed on stratified data.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.793
    Confidence Interval (2-Sided) 95%
    0.697 to 0.903
    Parameter Dispersion Type:
    Value:
    Estimation Comments Analysis was performed on stratified data.
    3. Secondary Outcome
    Title Percentage of Participants Achieving an Objective Response (Objective Response Rate)
    Description The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Response was defined using RECIST, v. 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameter.
    Time Frame Randomization until Disease Progression Up to 38.01 Months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI
    Arm/Group Description On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion. On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.
    Measure Participants 536 536
    Number (95% Confidence Interval) [percentage of participants]
    13.4
    2.5%
    12.5
    2.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ramucirumab + FOLFIRI, Placebo + FOLFIRI
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.6336
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    4. Secondary Outcome
    Title Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status
    Description The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Maximum improvement is the best post-baseline change.
    Time Frame Baseline Up to 171 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had EORTC QLQ-C30 assessed at baseline and post-baseline .
    Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI
    Arm/Group Description On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion. On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.
    Measure Participants 491 486
    Mean (Standard Deviation) [units on a scale]
    4.0
    (20.61)
    6.6
    (18.84)
    5. Secondary Outcome
    Title Change From Baseline in EuroQol- 5D (EQ-5D)
    Description The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.
    Time Frame Baseline and 30-Day Follow-Up (FU) up to 171 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had EQ-5D assessed at baseline and 30-day FU.
    Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI
    Arm/Group Description On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion. On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.
    Measure Participants 308 310
    Mean (Standard Deviation) [units on a scale]
    -0.097
    (0.279)
    -0.103
    (0.264)
    6. Secondary Outcome
    Title Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies
    Description Blood samples were tested to determine if a participant reacted to ramucirumab by producing anti-ramucirumab antibodies. Samples were identified as treatment emergent anti-drug antibody (TE ADA) if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)*100.
    Time Frame Cycles 1, 3, 5, and 30-Day FU

    Outcome Measure Data

    Analysis Population Description
    All participants who received study treatment and who had immunogenicity samples analyzed at the specified time points.
    Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI
    Arm/Group Description On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion. On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.
    Measure Participants 516 512
    Immunogenicity Any Time During Study (n=516, 512)
    5.6
    1%
    5.5
    1%
    Immunogenicity Post-Treatment (n=477, 473)
    3.1
    0.6%
    3.8
    0.7%
    7. Secondary Outcome
    Title Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab
    Description
    Time Frame Preinfusion and 1 hour postinfusion in Cycles 3, 5, 9, 13, and 17

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable data for Cmin and Cmax.
    Arm/Group Title Ramucirumab + FOLFIRI
    Arm/Group Description On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.
    Measure Participants 248
    Cmin Dose 3 (n=248)
    46.3
    (45.0)
    Cmin Dose 5 (n=154)
    65.1
    (43.0)
    Cmin Dose 9 (n=27)
    77.9
    (51.0)
    Cmin Dose 13 (n=11)
    75.9
    (43.0)
    Cmin Dose 17 (n=5)
    72.0
    (49.0)
    Cmax Dose 3 (n=88)
    221.0
    (37.0)
    Cmax Dose 5 (n=51)
    243.0
    (39.0)
    Cmax Dose 9 (n=18)
    262.0
    (36.0)
    Cmax Dose 13 (n=12)
    307.0
    (33.0)
    Cmax Dose 17 (n=7)
    253.0
    (19.0)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description One participant who was randomized into FOLFIRI + Placebo arm received Ramucirumab dose by mistake. For safety analysis of adverse events, this participant was categorized into FOLFIRI + Ramucirumab arm.
    Arm/Group Title FOLFIRI + Ramucirumab FOLFIRI + Placebo
    Arm/Group Description On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion. On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m^2 administered intravenously. Folinic Acid: 400 mg/m^2 administered intravenously. 5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.
    All Cause Mortality
    FOLFIRI + Ramucirumab FOLFIRI + Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    FOLFIRI + Ramucirumab FOLFIRI + Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 198/529 (37.4%) 175/528 (33.1%)
    Blood and lymphatic system disorders
    Anaemia 1/529 (0.2%) 1 1/528 (0.2%) 1
    Febrile neutropenia 15/529 (2.8%) 16 8/528 (1.5%) 8
    Leukopenia 1/529 (0.2%) 1 0/528 (0%) 0
    Neutropenia 6/529 (1.1%) 7 1/528 (0.2%) 1
    Thrombocytopenia 0/529 (0%) 0 2/528 (0.4%) 4
    Thrombotic microangiopathy 1/529 (0.2%) 1 0/528 (0%) 0
    Cardiac disorders
    Acute myocardial infarction 1/529 (0.2%) 1 0/528 (0%) 0
    Angina pectoris 2/529 (0.4%) 2 0/528 (0%) 0
    Atrial fibrillation 0/529 (0%) 0 1/528 (0.2%) 1
    Atrial flutter 0/529 (0%) 0 1/528 (0.2%) 1
    Cardiac failure 2/529 (0.4%) 2 2/528 (0.4%) 2
    Cardio-respiratory arrest 0/529 (0%) 0 1/528 (0.2%) 1
    Congestive cardiomyopathy 1/529 (0.2%) 1 0/528 (0%) 0
    Myocardial infarction 0/529 (0%) 0 3/528 (0.6%) 3
    Pericarditis 0/529 (0%) 0 1/528 (0.2%) 1
    Right ventricular failure 1/529 (0.2%) 1 0/528 (0%) 0
    Congenital, familial and genetic disorders
    Pyloric stenosis 1/529 (0.2%) 1 0/528 (0%) 0
    Eye disorders
    Cataract 1/529 (0.2%) 2 0/528 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 10/529 (1.9%) 12 14/528 (2.7%) 15
    Abdominal pain lower 0/529 (0%) 0 2/528 (0.4%) 2
    Abdominal pain upper 2/529 (0.4%) 3 0/528 (0%) 0
    Anal fistula 0/529 (0%) 0 1/528 (0.2%) 1
    Anal haemorrhage 1/529 (0.2%) 2 0/528 (0%) 0
    Anal ulcer 1/529 (0.2%) 1 0/528 (0%) 0
    Ascites 1/529 (0.2%) 2 3/528 (0.6%) 3
    Colitis 2/529 (0.4%) 2 2/528 (0.4%) 4
    Constipation 2/529 (0.4%) 3 3/528 (0.6%) 4
    Diarrhoea 19/529 (3.6%) 20 18/528 (3.4%) 21
    Dyspepsia 1/529 (0.2%) 1 0/528 (0%) 0
    Enteritis 0/529 (0%) 0 1/528 (0.2%) 1
    Enterocolitis 1/529 (0.2%) 1 0/528 (0%) 0
    Gastric haemorrhage 1/529 (0.2%) 1 0/528 (0%) 0
    Gastritis 3/529 (0.6%) 3 1/528 (0.2%) 1
    Gastrointestinal inflammation 0/529 (0%) 0 1/528 (0.2%) 2
    Gastrointestinal perforation 1/529 (0.2%) 1 0/528 (0%) 0
    Haematemesis 3/529 (0.6%) 3 0/528 (0%) 0
    Haemorrhoidal haemorrhage 1/529 (0.2%) 2 0/528 (0%) 0
    Hernial eventration 0/529 (0%) 0 1/528 (0.2%) 1
    Ileus 3/529 (0.6%) 5 6/528 (1.1%) 6
    Incarcerated inguinal hernia 0/529 (0%) 0 1/528 (0.2%) 1
    Inflammatory bowel disease 1/529 (0.2%) 1 0/528 (0%) 0
    Inguinal hernia 2/529 (0.4%) 2 1/528 (0.2%) 1
    Intestinal haemorrhage 0/529 (0%) 0 1/528 (0.2%) 1
    Intestinal obstruction 8/529 (1.5%) 8 11/528 (2.1%) 11
    Intestinal perforation 3/529 (0.6%) 3 0/528 (0%) 0
    Large intestinal haemorrhage 1/529 (0.2%) 1 1/528 (0.2%) 1
    Large intestinal obstruction 3/529 (0.6%) 3 3/528 (0.6%) 3
    Large intestinal stenosis 0/529 (0%) 0 2/528 (0.4%) 2
    Large intestine perforation 4/529 (0.8%) 4 1/528 (0.2%) 1
    Lower gastrointestinal haemorrhage 1/529 (0.2%) 1 4/528 (0.8%) 4
    Mechanical ileus 1/529 (0.2%) 1 0/528 (0%) 0
    Nausea 8/529 (1.5%) 8 6/528 (1.1%) 8
    Oesophageal varices haemorrhage 1/529 (0.2%) 1 0/528 (0%) 0
    Oesophagitis 1/529 (0.2%) 1 0/528 (0%) 0
    Proctalgia 1/529 (0.2%) 1 0/528 (0%) 0
    Rectal haemorrhage 1/529 (0.2%) 1 2/528 (0.4%) 2
    Rectal obstruction 0/529 (0%) 0 1/528 (0.2%) 1
    Rectal perforation 0/529 (0%) 0 1/528 (0.2%) 1
    Rectal ulcer 1/529 (0.2%) 1 0/528 (0%) 0
    Small intestinal haemorrhage 1/529 (0.2%) 1 0/528 (0%) 0
    Small intestinal obstruction 7/529 (1.3%) 7 5/528 (0.9%) 5
    Small intestinal perforation 1/529 (0.2%) 1 0/528 (0%) 0
    Stomatitis 0/529 (0%) 0 3/528 (0.6%) 3
    Subileus 1/529 (0.2%) 1 1/528 (0.2%) 1
    Vomiting 13/529 (2.5%) 14 6/528 (1.1%) 7
    General disorders
    Asthenia 4/529 (0.8%) 4 3/528 (0.6%) 3
    Chest pain 1/529 (0.2%) 1 3/528 (0.6%) 3
    Disease progression 1/529 (0.2%) 1 0/528 (0%) 0
    Fatigue 5/529 (0.9%) 5 4/528 (0.8%) 4
    General physical health deterioration 3/529 (0.6%) 4 5/528 (0.9%) 5
    Hernia obstructive 1/529 (0.2%) 1 0/528 (0%) 0
    Malaise 3/529 (0.6%) 3 0/528 (0%) 0
    Mucosal inflammation 4/529 (0.8%) 5 2/528 (0.4%) 2
    Multi-organ failure 1/529 (0.2%) 1 1/528 (0.2%) 1
    Non-cardiac chest pain 1/529 (0.2%) 1 1/528 (0.2%) 1
    Oedema peripheral 0/529 (0%) 0 1/528 (0.2%) 1
    Pyrexia 4/529 (0.8%) 5 8/528 (1.5%) 10
    Systemic inflammatory response syndrome 2/529 (0.4%) 2 0/528 (0%) 0
    Ulcer haemorrhage 1/529 (0.2%) 1 0/528 (0%) 0
    Hepatobiliary disorders
    Acute hepatic failure 0/529 (0%) 0 1/528 (0.2%) 1
    Bile duct obstruction 2/529 (0.4%) 2 1/528 (0.2%) 1
    Bile duct stenosis 1/529 (0.2%) 1 2/528 (0.4%) 2
    Cholangitis 0/529 (0%) 0 1/528 (0.2%) 1
    Cholangitis chronic 0/529 (0%) 0 1/528 (0.2%) 1
    Cholecystitis 1/529 (0.2%) 1 2/528 (0.4%) 2
    Cholelithiasis obstructive 1/529 (0.2%) 1 0/528 (0%) 0
    Cholestasis 0/529 (0%) 0 1/528 (0.2%) 1
    Hepatic cirrhosis 1/529 (0.2%) 1 0/528 (0%) 0
    Hepatic failure 1/529 (0.2%) 1 0/528 (0%) 0
    Hepatic function abnormal 1/529 (0.2%) 1 0/528 (0%) 0
    Hepatorenal syndrome 0/529 (0%) 0 1/528 (0.2%) 1
    Hepatotoxicity 0/529 (0%) 0 1/528 (0.2%) 1
    Hyperbilirubinaemia 1/529 (0.2%) 1 1/528 (0.2%) 2
    Jaundice 1/529 (0.2%) 1 0/528 (0%) 0
    Jaundice cholestatic 1/529 (0.2%) 2 2/528 (0.4%) 2
    Liver disorder 0/529 (0%) 0 1/528 (0.2%) 1
    Portal hypertension 0/529 (0%) 0 1/528 (0.2%) 1
    Immune system disorders
    Anaphylactic reaction 1/529 (0.2%) 1 1/528 (0.2%) 1
    Drug hypersensitivity 0/529 (0%) 0 1/528 (0.2%) 1
    Infections and infestations
    Abdominal infection 1/529 (0.2%) 1 0/528 (0%) 0
    Atypical pneumonia 0/529 (0%) 0 1/528 (0.2%) 1
    Bacteraemia 2/529 (0.4%) 2 1/528 (0.2%) 1
    Biliary tract infection 1/529 (0.2%) 1 0/528 (0%) 0
    Bronchitis 0/529 (0%) 0 1/528 (0.2%) 1
    Bronchopulmonary aspergillosis 0/529 (0%) 0 1/528 (0.2%) 1
    Campylobacter gastroenteritis 0/529 (0%) 0 1/528 (0.2%) 1
    Cellulitis 0/529 (0%) 0 1/528 (0.2%) 1
    Clostridium difficile colitis 4/529 (0.8%) 5 1/528 (0.2%) 1
    Cystitis 0/529 (0%) 0 1/528 (0.2%) 3
    Device related infection 1/529 (0.2%) 2 1/528 (0.2%) 1
    Device related sepsis 0/529 (0%) 0 1/528 (0.2%) 1
    Erysipelas 0/529 (0%) 0 1/528 (0.2%) 1
    Escherichia sepsis 1/529 (0.2%) 1 0/528 (0%) 0
    Gastroenteritis 0/529 (0%) 0 2/528 (0.4%) 2
    Herpes zoster 0/529 (0%) 0 1/528 (0.2%) 1
    Infection 2/529 (0.4%) 2 1/528 (0.2%) 1
    Infective exacerbation of chronic obstructive airways disease 0/529 (0%) 0 1/528 (0.2%) 1
    Influenza 0/529 (0%) 0 1/528 (0.2%) 1
    Klebsiella infection 0/529 (0%) 0 1/528 (0.2%) 1
    Klebsiella sepsis 0/529 (0%) 0 2/528 (0.4%) 2
    Localised infection 1/529 (0.2%) 1 0/528 (0%) 0
    Lung abscess 1/529 (0.2%) 1 0/528 (0%) 0
    Lung infection 1/529 (0.2%) 1 0/528 (0%) 0
    Mastoiditis 1/529 (0.2%) 1 0/528 (0%) 0
    Neutropenic infection 0/529 (0%) 0 1/528 (0.2%) 1
    Oral candidiasis 0/529 (0%) 0 1/528 (0.2%) 1
    Pelvic abscess 1/529 (0.2%) 1 0/528 (0%) 0
    Pelvic infection 1/529 (0.2%) 1 0/528 (0%) 0
    Perirectal abscess 0/529 (0%) 0 2/528 (0.4%) 2
    Peritonitis 2/529 (0.4%) 2 0/528 (0%) 0
    Peritonitis bacterial 1/529 (0.2%) 2 0/528 (0%) 0
    Pneumonia 7/529 (1.3%) 7 7/528 (1.3%) 7
    Pyelonephritis 1/529 (0.2%) 2 0/528 (0%) 0
    Respiratory tract infection 0/529 (0%) 0 1/528 (0.2%) 1
    Salmonellosis 1/529 (0.2%) 1 0/528 (0%) 0
    Sepsis 5/529 (0.9%) 5 11/528 (2.1%) 13
    Septic shock 2/529 (0.4%) 2 0/528 (0%) 0
    Sinusitis 1/529 (0.2%) 1 0/528 (0%) 0
    Upper respiratory tract infection 1/529 (0.2%) 1 1/528 (0.2%) 1
    Urinary tract infection 4/529 (0.8%) 4 5/528 (0.9%) 6
    Wound infection 1/529 (0.2%) 1 0/528 (0%) 0
    Injury, poisoning and procedural complications
    Alcohol poisoning 1/529 (0.2%) 1 0/528 (0%) 0
    Ankle fracture 1/529 (0.2%) 1 0/528 (0%) 0
    Compression fracture 1/529 (0.2%) 2 0/528 (0%) 0
    Fall 5/529 (0.9%) 5 2/528 (0.4%) 2
    Femur fracture 0/529 (0%) 0 1/528 (0.2%) 1
    Fibula fracture 1/529 (0.2%) 1 0/528 (0%) 0
    Hepatic haematoma 0/529 (0%) 0 1/528 (0.2%) 1
    Hip fracture 2/529 (0.4%) 2 1/528 (0.2%) 1
    Lower limb fracture 1/529 (0.2%) 1 0/528 (0%) 0
    Lumbar vertebral fracture 0/529 (0%) 0 1/528 (0.2%) 1
    Post procedural urine leak 0/529 (0%) 0 1/528 (0.2%) 1
    Procedural intestinal perforation 1/529 (0.2%) 1 0/528 (0%) 0
    Spinal fracture 0/529 (0%) 0 1/528 (0.2%) 1
    Stoma site haemorrhage 1/529 (0.2%) 1 0/528 (0%) 0
    Subdural haematoma 0/529 (0%) 0 1/528 (0.2%) 1
    Wound dehiscence 1/529 (0.2%) 1 0/528 (0%) 0
    Investigations
    Alanine aminotransferase increased 1/529 (0.2%) 1 2/528 (0.4%) 2
    Aspartate aminotransferase increased 1/529 (0.2%) 1 0/528 (0%) 0
    Blood bilirubin increased 3/529 (0.6%) 3 2/528 (0.4%) 2
    Blood creatinine increased 1/529 (0.2%) 1 1/528 (0.2%) 1
    Blood culture positive 1/529 (0.2%) 1 0/528 (0%) 0
    Eastern cooperative oncology group performance status worsened 0/529 (0%) 0 1/528 (0.2%) 4
    International normalised ratio increased 3/529 (0.6%) 3 0/528 (0%) 0
    Neutrophil count decreased 2/529 (0.4%) 3 1/528 (0.2%) 1
    Platelet count decreased 1/529 (0.2%) 1 0/528 (0%) 0
    Weight decreased 1/529 (0.2%) 1 0/528 (0%) 0
    Metabolism and nutrition disorders
    Cachexia 0/529 (0%) 0 1/528 (0.2%) 1
    Decreased appetite 7/529 (1.3%) 8 3/528 (0.6%) 4
    Dehydration 3/529 (0.6%) 4 6/528 (1.1%) 7
    Hyperglycaemia 1/529 (0.2%) 1 1/528 (0.2%) 1
    Hypoalbuminaemia 1/529 (0.2%) 1 0/528 (0%) 0
    Hypokalaemia 1/529 (0.2%) 3 3/528 (0.6%) 9
    Malnutrition 1/529 (0.2%) 2 0/528 (0%) 0
    Tumour lysis syndrome 0/529 (0%) 0 1/528 (0.2%) 1
    Musculoskeletal and connective tissue disorders
    Back pain 2/529 (0.4%) 3 1/528 (0.2%) 1
    Musculoskeletal pain 0/529 (0%) 0 1/528 (0.2%) 1
    Neuropathic arthropathy 0/529 (0%) 0 1/528 (0.2%) 1
    Rheumatoid arthritis 0/529 (0%) 0 1/528 (0.2%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colorectal cancer metastatic 1/529 (0.2%) 1 1/528 (0.2%) 1
    Malignant ascites 1/529 (0.2%) 1 0/528 (0%) 0
    Malignant pleural effusion 0/529 (0%) 0 2/528 (0.4%) 2
    Metastases to meninges 0/529 (0%) 0 1/528 (0.2%) 1
    Metastatic neoplasm 0/529 (0%) 0 1/528 (0.2%) 1
    Tumour haemorrhage 1/529 (0.2%) 1 0/528 (0%) 0
    Tumour pain 1/529 (0.2%) 1 0/528 (0%) 0
    Nervous system disorders
    Aphasia 1/529 (0.2%) 1 0/528 (0%) 0
    Cerebral haematoma 0/529 (0%) 0 1/528 (0.2%) 1
    Cerebral ischaemia 1/529 (0.2%) 1 0/528 (0%) 0
    Cerebrovascular accident 0/529 (0%) 0 1/528 (0.2%) 1
    Dizziness 1/529 (0.2%) 1 2/528 (0.4%) 2
    Dysarthria 1/529 (0.2%) 1 0/528 (0%) 0
    Epilepsy 1/529 (0.2%) 1 0/528 (0%) 0
    Headache 1/529 (0.2%) 1 0/528 (0%) 0
    Hyperammonaemic encephalopathy 1/529 (0.2%) 1 0/528 (0%) 0
    Ischaemic stroke 0/529 (0%) 0 1/528 (0.2%) 1
    Memory impairment 0/529 (0%) 0 1/528 (0.2%) 1
    Optic neuritis 1/529 (0.2%) 1 0/528 (0%) 0
    Posterior reversible encephalopathy syndrome 1/529 (0.2%) 1 1/528 (0.2%) 1
    Presyncope 0/529 (0%) 0 1/528 (0.2%) 1
    Syncope 1/529 (0.2%) 1 1/528 (0.2%) 1
    Transient ischaemic attack 1/529 (0.2%) 1 0/528 (0%) 0
    Psychiatric disorders
    Alcohol abuse 0/529 (0%) 0 1/528 (0.2%) 1
    Anxiety 1/529 (0.2%) 1 0/528 (0%) 0
    Confusional state 1/529 (0.2%) 1 1/528 (0.2%) 1
    Delirium 0/529 (0%) 0 1/528 (0.2%) 1
    Depression 1/529 (0.2%) 1 0/528 (0%) 0
    Disorientation 1/529 (0.2%) 1 0/528 (0%) 0
    Mental status changes 2/529 (0.4%) 2 0/528 (0%) 0
    Suicide attempt 0/529 (0%) 0 1/528 (0.2%) 1
    Renal and urinary disorders
    Acute prerenal failure 1/529 (0.2%) 1 0/528 (0%) 0
    Haematuria 1/529 (0.2%) 1 1/528 (0.2%) 2
    Hydronephrosis 2/529 (0.4%) 2 1/528 (0.2%) 1
    Nephrolithiasis 1/529 (0.2%) 1 0/528 (0%) 0
    Nephrotic syndrome 3/529 (0.6%) 6 0/528 (0%) 0
    Prerenal failure 0/529 (0%) 0 1/528 (0.2%) 1
    Renal failure 1/529 (0.2%) 1 1/528 (0.2%) 1
    Renal failure acute 3/529 (0.6%) 4 6/528 (1.1%) 6
    Urinary incontinence 0/529 (0%) 0 1/528 (0.2%) 1
    Urinary retention 2/529 (0.4%) 2 0/528 (0%) 0
    Urinary tract obstruction 1/529 (0.2%) 2 0/528 (0%) 0
    Reproductive system and breast disorders
    Pelvic pain 1/529 (0.2%) 1 0/528 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 2/529 (0.4%) 2 0/528 (0%) 0
    Dyspnoea 1/529 (0.2%) 1 5/528 (0.9%) 6
    Haemoptysis 1/529 (0.2%) 1 0/528 (0%) 0
    Interstitial lung disease 1/529 (0.2%) 3 2/528 (0.4%) 2
    Laryngeal inflammation 1/529 (0.2%) 1 0/528 (0%) 0
    Lung infiltration 1/529 (0.2%) 1 0/528 (0%) 0
    Pleural effusion 1/529 (0.2%) 1 3/528 (0.6%) 4
    Pneumothorax 1/529 (0.2%) 1 1/528 (0.2%) 1
    Pneumothorax spontaneous 0/529 (0%) 0 1/528 (0.2%) 1
    Pulmonary embolism 10/529 (1.9%) 10 6/528 (1.1%) 6
    Pulmonary oedema 0/529 (0%) 0 1/528 (0.2%) 1
    Respiratory arrest 0/529 (0%) 0 1/528 (0.2%) 1
    Respiratory distress 1/529 (0.2%) 1 0/528 (0%) 0
    Skin and subcutaneous tissue disorders
    Dermal cyst 1/529 (0.2%) 1 0/528 (0%) 0
    Skin ulcer 2/529 (0.4%) 2 0/528 (0%) 0
    Surgical and medical procedures
    Cancer surgery 1/529 (0.2%) 1 0/528 (0%) 0
    Colostomy closure 0/529 (0%) 0 1/528 (0.2%) 1
    Enterostomy 1/529 (0.2%) 2 0/528 (0%) 0
    High frequency ablation 1/529 (0.2%) 1 0/528 (0%) 0
    Vascular disorders
    Aortic dissection 0/529 (0%) 0 1/528 (0.2%) 1
    Deep vein thrombosis 2/529 (0.4%) 2 3/528 (0.6%) 3
    Embolism 2/529 (0.4%) 2 3/528 (0.6%) 3
    Hypertension 4/529 (0.8%) 4 0/528 (0%) 0
    Hypertensive crisis 1/529 (0.2%) 1 0/528 (0%) 0
    Hypotension 2/529 (0.4%) 3 1/528 (0.2%) 1
    Hypovolaemic shock 0/529 (0%) 0 1/528 (0.2%) 1
    Jugular vein thrombosis 1/529 (0.2%) 1 2/528 (0.4%) 2
    Lymphoedema 0/529 (0%) 0 1/528 (0.2%) 1
    Subclavian vein thrombosis 0/529 (0%) 0 1/528 (0.2%) 1
    Thrombophlebitis superficial 0/529 (0%) 0 1/528 (0.2%) 1
    Vena cava embolism 0/529 (0%) 0 1/528 (0.2%) 1
    Venous thrombosis 3/529 (0.6%) 3 1/528 (0.2%) 1
    Other (Not Including Serious) Adverse Events
    FOLFIRI + Ramucirumab FOLFIRI + Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 518/529 (97.9%) 510/528 (96.6%)
    Blood and lymphatic system disorders
    Anaemia 93/529 (17.6%) 225 117/528 (22.2%) 270
    Neutropenia 183/529 (34.6%) 510 131/528 (24.8%) 259
    Thrombocytopenia 80/529 (15.1%) 177 42/528 (8%) 82
    Gastrointestinal disorders
    Abdominal distension 22/529 (4.2%) 26 27/528 (5.1%) 29
    Abdominal pain 124/529 (23.4%) 178 123/528 (23.3%) 181
    Constipation 157/529 (29.7%) 227 132/528 (25%) 196
    Diarrhoea 315/529 (59.5%) 881 271/528 (51.3%) 798
    Dyspepsia 26/529 (4.9%) 28 27/528 (5.1%) 32
    Haemorrhoids 27/529 (5.1%) 33 6/528 (1.1%) 7
    Nausea 265/529 (50.1%) 650 274/528 (51.9%) 715
    Proctalgia 27/529 (5.1%) 35 13/528 (2.5%) 16
    Stomatitis 166/529 (31.4%) 380 113/528 (21.4%) 235
    Vomiting 151/529 (28.5%) 299 143/528 (27.1%) 309
    General disorders
    Asthenia 74/529 (14%) 228 62/528 (11.7%) 168
    Fatigue 254/529 (48%) 645 225/528 (42.6%) 588
    Malaise 41/529 (7.8%) 97 38/528 (7.2%) 104
    Mucosal inflammation 91/529 (17.2%) 218 52/528 (9.8%) 92
    Oedema peripheral 118/529 (22.3%) 148 50/528 (9.5%) 59
    Pyrexia 85/529 (16.1%) 135 61/528 (11.6%) 93
    Infections and infestations
    Upper respiratory tract infection 36/529 (6.8%) 44 22/528 (4.2%) 25
    Urinary tract infection 34/529 (6.4%) 43 21/528 (4%) 35
    Investigations
    Alanine aminotransferase increased 28/529 (5.3%) 59 19/528 (3.6%) 59
    Aspartate aminotransferase increased 34/529 (6.4%) 57 18/528 (3.4%) 42
    Blood alkaline phosphatase increased 36/529 (6.8%) 66 27/528 (5.1%) 57
    Neutrophil count decreased 137/529 (25.9%) 437 115/528 (21.8%) 278
    Platelet count decreased 80/529 (15.1%) 232 36/528 (6.8%) 59
    Weight decreased 76/529 (14.4%) 124 46/528 (8.7%) 69
    White blood cell count decreased 49/529 (9.3%) 146 51/528 (9.7%) 136
    Metabolism and nutrition disorders
    Decreased appetite 203/529 (38.4%) 382 149/528 (28.2%) 359
    Dehydration 32/529 (6%) 46 26/528 (4.9%) 32
    Hypoalbuminaemia 35/529 (6.6%) 59 13/528 (2.5%) 20
    Hypokalaemia 39/529 (7.4%) 65 38/528 (7.2%) 72
    Musculoskeletal and connective tissue disorders
    Arthralgia 33/529 (6.2%) 38 22/528 (4.2%) 26
    Back pain 43/529 (8.1%) 54 48/528 (9.1%) 128
    Pain in extremity 36/529 (6.8%) 58 19/528 (3.6%) 25
    Nervous system disorders
    Dizziness 38/529 (7.2%) 46 33/528 (6.3%) 51
    Dysgeusia 43/529 (8.1%) 57 39/528 (7.4%) 57
    Headache 80/529 (15.1%) 114 41/528 (7.8%) 69
    Peripheral sensory neuropathy 33/529 (6.2%) 57 38/528 (7.2%) 49
    Psychiatric disorders
    Insomnia 47/529 (8.9%) 51 54/528 (10.2%) 84
    Renal and urinary disorders
    Proteinuria 94/529 (17.8%) 227 30/528 (5.7%) 40
    Respiratory, thoracic and mediastinal disorders
    Cough 69/529 (13%) 88 46/528 (8.7%) 60
    Dysphonia 31/529 (5.9%) 32 5/528 (0.9%) 6
    Dyspnoea 56/529 (10.6%) 86 51/528 (9.7%) 70
    Epistaxis 182/529 (34.4%) 254 80/528 (15.2%) 99
    Hiccups 30/529 (5.7%) 81 17/528 (3.2%) 22
    Skin and subcutaneous tissue disorders
    Alopecia 156/529 (29.5%) 198 168/528 (31.8%) 191
    Dry skin 29/529 (5.5%) 35 23/528 (4.4%) 25
    Palmar-plantar erythrodysaesthesia syndrome 69/529 (13%) 108 29/528 (5.5%) 39
    Rash 42/529 (7.9%) 47 36/528 (6.8%) 45
    Vascular disorders
    Hypertension 147/529 (27.8%) 287 51/528 (9.7%) 108

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01183780
    Other Study ID Numbers:
    • 13856
    • I4T-MC-JVBB
    • CP12-0920
    • 2010-021037-32
    • CTRI/2011/07/001900
    First Posted:
    Aug 18, 2010
    Last Update Posted:
    Sep 25, 2019
    Last Verified:
    Sep 1, 2019