Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01183780




Registration number
NCT01183780
Ethics application status
Date submitted
4/08/2010
Date registered
18/08/2010
Date last updated
25/09/2019

Titles & IDs
Public title
A Study in Second Line Metastatic Colorectal Cancer
Scientific 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
Secondary ID [1] 0 0
I4T-MC-JVBB
Secondary ID [2] 0 0
13856
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Ramucirumab
Treatment: Other - Placebo
Treatment: Drugs - Irinotecan
Treatment: Drugs - Folinic Acid
Treatment: Drugs - 5-Fluorouracil

Experimental: FOLFIRI + Ramucirumab -

Placebo comparator: FOLFIRI + Placebo -


Treatment: Other: 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

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

Treatment: Drugs: 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

Treatment: Drugs: 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

Treatment: Drugs: 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 code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization to Date of Death from Any Cause Up to 39.36 Months
Secondary outcome [1] 0 0
Progression-free Survival (PFS) Time
Timepoint [1] 0 0
Randomization to Measured PD or Date of Death from Any Cause Up to 38.01 Months
Secondary outcome [2] 0 0
Percentage of Participants Achieving an Objective Response (Objective Response Rate)
Timepoint [2] 0 0
Randomization until Disease Progression Up to 38.01 Months
Secondary outcome [3] 0 0
Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status
Timepoint [3] 0 0
Baseline Up to 171 Weeks
Secondary outcome [4] 0 0
Change From Baseline in EuroQol- 5D (EQ-5D)
Timepoint [4] 0 0
Baseline and 30-Day Follow-Up (FU) up to 171 Weeks
Secondary outcome [5] 0 0
Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies
Timepoint [5] 0 0
Cycles 1, 3, 5, and 30-Day FU
Secondary outcome [6] 0 0
Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab
Timepoint [6] 0 0
Preinfusion and 1 hour postinfusion in Cycles 3, 5, 9, 13, and 17

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/06/2016
Sample size
Target
Accrual to date
Final
1072
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
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. - Liverpool
Recruitment hospital [2] 0 0
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. - Randwick
Recruitment hospital [3] 0 0
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. - St. Leonards
Recruitment hospital [4] 0 0
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. - Wodonga
Recruitment hospital [5] 0 0
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. - Wollongong
Recruitment hospital [6] 0 0
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. - Woolloongabba
Recruitment hospital [7] 0 0
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 Park
Recruitment hospital [8] 0 0
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. - Elizabeth Vale
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2065 - St. Leonards
Recruitment postcode(s) [4] 0 0
3690 - Wodonga
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
5112 - Elizabeth Vale
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New Mexico
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Oregon
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Utah
Country [28] 0 0
United States of America
State/province [28] 0 0
Virginia
Country [29] 0 0
United States of America
State/province [29] 0 0
Washington
Country [30] 0 0
United States of America
State/province [30] 0 0
Wisconsin
Country [31] 0 0
Argentina
State/province [31] 0 0
Buenos Aires
Country [32] 0 0
Argentina
State/province [32] 0 0
Caba
Country [33] 0 0
Argentina
State/province [33] 0 0
Rosario
Country [34] 0 0
Argentina
State/province [34] 0 0
Santa Fe
Country [35] 0 0
Argentina
State/province [35] 0 0
Tucumain
Country [36] 0 0
Argentina
State/province [36] 0 0
Viedma
Country [37] 0 0
Austria
State/province [37] 0 0
Innsbruck
Country [38] 0 0
Austria
State/province [38] 0 0
Krems
Country [39] 0 0
Austria
State/province [39] 0 0
Vienna
Country [40] 0 0
Belgium
State/province [40] 0 0
Bonheiden
Country [41] 0 0
Belgium
State/province [41] 0 0
Brussels
Country [42] 0 0
Belgium
State/province [42] 0 0
Charleroi
Country [43] 0 0
Belgium
State/province [43] 0 0
Edegem
Country [44] 0 0
Belgium
State/province [44] 0 0
Haine-St.- Paul
Country [45] 0 0
Belgium
State/province [45] 0 0
Leuven
Country [46] 0 0
Belgium
State/province [46] 0 0
Liège
Country [47] 0 0
Brazil
State/province [47] 0 0
Ijui
Country [48] 0 0
Brazil
State/province [48] 0 0
Itajai
Country [49] 0 0
Brazil
State/province [49] 0 0
Rio De Janeiro
Country [50] 0 0
Brazil
State/province [50] 0 0
Salvador
Country [51] 0 0
Brazil
State/province [51] 0 0
Sao Jose Do Rio Preto
Country [52] 0 0
Brazil
State/province [52] 0 0
São Paulo
Country [53] 0 0
Czechia
State/province [53] 0 0
Brno
Country [54] 0 0
Czechia
State/province [54] 0 0
Pardubice
Country [55] 0 0
Czechia
State/province [55] 0 0
Prague
Country [56] 0 0
Denmark
State/province [56] 0 0
Copenhagen
Country [57] 0 0
Denmark
State/province [57] 0 0
Odense
Country [58] 0 0
Finland
State/province [58] 0 0
Helsinki
Country [59] 0 0
Finland
State/province [59] 0 0
Tampere
Country [60] 0 0
France
State/province [60] 0 0
Bordeaux
Country [61] 0 0
France
State/province [61] 0 0
La Chaussee Saint Victor
Country [62] 0 0
France
State/province [62] 0 0
Le Mans
Country [63] 0 0
France
State/province [63] 0 0
Nantes
Country [64] 0 0
France
State/province [64] 0 0
Paris
Country [65] 0 0
France
State/province [65] 0 0
Poitiers
Country [66] 0 0
France
State/province [66] 0 0
Strasbourg
Country [67] 0 0
Germany
State/province [67] 0 0
Augsburg
Country [68] 0 0
Germany
State/province [68] 0 0
Balingen
Country [69] 0 0
Germany
State/province [69] 0 0
Bamberg
Country [70] 0 0
Germany
State/province [70] 0 0
Dresden
Country [71] 0 0
Germany
State/province [71] 0 0
Frankfurt
Country [72] 0 0
Germany
State/province [72] 0 0
Halle
Country [73] 0 0
Germany
State/province [73] 0 0
Hamburg
Country [74] 0 0
Germany
State/province [74] 0 0
Lübeck
Country [75] 0 0
Germany
State/province [75] 0 0
Munich
Country [76] 0 0
Germany
State/province [76] 0 0
Mönchengladbach
Country [77] 0 0
Germany
State/province [77] 0 0
Weiden
Country [78] 0 0
Greece
State/province [78] 0 0
Athens
Country [79] 0 0
Greece
State/province [79] 0 0
Chania
Country [80] 0 0
Greece
State/province [80] 0 0
Ioannina
Country [81] 0 0
Hungary
State/province [81] 0 0
Budapest
Country [82] 0 0
Hungary
State/province [82] 0 0
Kecskemet
Country [83] 0 0
India
State/province [83] 0 0
Bangalore
Country [84] 0 0
India
State/province [84] 0 0
Kochin
Country [85] 0 0
India
State/province [85] 0 0
Kolkata
Country [86] 0 0
India
State/province [86] 0 0
New Delhi
Country [87] 0 0
India
State/province [87] 0 0
Trivandrum
Country [88] 0 0
Israel
State/province [88] 0 0
Beer Sheva
Country [89] 0 0
Israel
State/province [89] 0 0
Haifa
Country [90] 0 0
Israel
State/province [90] 0 0
Tel Hashomer
Country [91] 0 0
Israel
State/province [91] 0 0
Tel-Aviv
Country [92] 0 0
Italy
State/province [92] 0 0
Genova
Country [93] 0 0
Italy
State/province [93] 0 0
Livorno
Country [94] 0 0
Italy
State/province [94] 0 0
Macerata
Country [95] 0 0
Italy
State/province [95] 0 0
Padova
Country [96] 0 0
Italy
State/province [96] 0 0
Reggio Emilia
Country [97] 0 0
Italy
State/province [97] 0 0
Rome
Country [98] 0 0
Japan
State/province [98] 0 0
Aichi
Country [99] 0 0
Japan
State/province [99] 0 0
Chiba
Country [100] 0 0
Japan
State/province [100] 0 0
Ehime
Country [101] 0 0
Japan
State/province [101] 0 0
Fukuoka
Country [102] 0 0
Japan
State/province [102] 0 0
Gifu
Country [103] 0 0
Japan
State/province [103] 0 0
Hokkaido
Country [104] 0 0
Japan
State/province [104] 0 0
Hyogo
Country [105] 0 0
Japan
State/province [105] 0 0
Kanagawa
Country [106] 0 0
Japan
State/province [106] 0 0
Kochi
Country [107] 0 0
Japan
State/province [107] 0 0
Osaka
Country [108] 0 0
Japan
State/province [108] 0 0
Saitama
Country [109] 0 0
Japan
State/province [109] 0 0
Shizuoka
Country [110] 0 0
Japan
State/province [110] 0 0
Tochigi
Country [111] 0 0
Japan
State/province [111] 0 0
Tokyo
Country [112] 0 0
Korea, Republic of
State/province [112] 0 0
Anyang
Country [113] 0 0
Korea, Republic of
State/province [113] 0 0
Goyang-Si
Country [114] 0 0
Korea, Republic of
State/province [114] 0 0
Incheon
Country [115] 0 0
Korea, Republic of
State/province [115] 0 0
Seoul
Country [116] 0 0
Korea, Republic of
State/province [116] 0 0
Suwon-City
Country [117] 0 0
Netherlands
State/province [117] 0 0
Breda
Country [118] 0 0
Netherlands
State/province [118] 0 0
Deventer
Country [119] 0 0
Netherlands
State/province [119] 0 0
Eindhoven
Country [120] 0 0
Netherlands
State/province [120] 0 0
Groningen
Country [121] 0 0
Netherlands
State/province [121] 0 0
Sittard - Geleen
Country [122] 0 0
Portugal
State/province [122] 0 0
Coimbra
Country [123] 0 0
Portugal
State/province [123] 0 0
Porto
Country [124] 0 0
Puerto Rico
State/province [124] 0 0
Bayamon
Country [125] 0 0
Romania
State/province [125] 0 0
Bucharest
Country [126] 0 0
Romania
State/province [126] 0 0
Cluj-Napoca
Country [127] 0 0
Romania
State/province [127] 0 0
Iasi
Country [128] 0 0
Romania
State/province [128] 0 0
Oradea
Country [129] 0 0
Slovenia
State/province [129] 0 0
Ljubljana
Country [130] 0 0
Spain
State/province [130] 0 0
Barcelona
Country [131] 0 0
Spain
State/province [131] 0 0
Madrid
Country [132] 0 0
Spain
State/province [132] 0 0
Oviedo
Country [133] 0 0
Spain
State/province [133] 0 0
Pamplona
Country [134] 0 0
Spain
State/province [134] 0 0
Sabadell
Country [135] 0 0
Spain
State/province [135] 0 0
Sevilla
Country [136] 0 0
Spain
State/province [136] 0 0
Valencia
Country [137] 0 0
Sweden
State/province [137] 0 0
Stockholm
Country [138] 0 0
Sweden
State/province [138] 0 0
Uppsala
Country [139] 0 0
Taiwan
State/province [139] 0 0
Kaohsiung
Country [140] 0 0
Taiwan
State/province [140] 0 0
Kuei Shan Hsiang
Country [141] 0 0
Taiwan
State/province [141] 0 0
Taichung
Country [142] 0 0
Taiwan
State/province [142] 0 0
Tainan
Country [143] 0 0
Taiwan
State/province [143] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01183780
Trial related presentations / publications
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.
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.
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.
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.
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.
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.
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.
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. Erratum In: Lancet Oncol. 2015 Jun;16(6):e262. doi: 10.1016/S1470-2045(15)70273-1.
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01183780