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A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma (RAINBOW)

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ramucirumab (IMC-1211B) DP
Placebo
Paclitaxel
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Metastatic Adenocarcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent
  • histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
  • Metastatic disease or locally advanced, unresectable disease
  • Disease progression during or within 4 months after the last dose of the first-line therapy (platinum/fluoropyrimidine doublet with or without anthracycline)
  • Organs are functioning well (liver, kidney, blood)
  • Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1

Exclusion Criteria:

  • First line chemotherapy for metastatic gastric cancer other than platinum/fluoropyrimidine doublet with or without anthracycline
  • Previous systemic therapy with other anti-angiogenic drugs
  • Uncontrolled high blood pressure
  • Symptomatic or poorly controlled heart disease or had a heart attack or stroke within the last 6 month
  • Evidence of central nervous system (CNS) metastasis at baseline

Sites / Locations

  • ImClone Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ramucirumab (IMC-1211B) Drug Product (DP) and Paclitaxel

Placebo and Paclitaxel

Arm Description

Ramucirumab (IMC-1211B) DP and Paclitaxel

Placebo and Paclitaxel

Outcomes

Primary Outcome Measures

Overall Survival Time (OS)
OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.

Secondary Outcome Measures

Progression-Free Survival (PFS)
PFS was measured from date of randomization to first radiographically documented progressive disease (PD) or death due to any cause. PD defined using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Participants who had no baseline or post baseline radiological tumor assessment were censored at date of randomization. Participants who had no tumor progression or death within 2 scan intervals following the last assessment were censored at the date of last radiographic tumor assessment. Participants who began new anticancer treatment and had no tumor progression were censored at date of assessment prior to initiation of new therapy. Participants lost to follow-up or withdrew consent were censored at the date of their last assessment.
Time to Progressive Disease (TTP)
TTP was defined as the time from randomization until date of radiographic progression using RECIST v1.1 criteria. PD was defined as having a ≥20% increase in sum of longest diameter (LD) of target lesions and at minimum 5 millimeters (mm) increase above nadir. Participants who did not progress or were lost to follow-up were censored at the date of last tumor assessment. Participants who had no baseline tumor assessment or no post baseline assessment and no death reported with 2 scan intervals post randomization were censored at date of randomization. Participants with no progression and not died within 2 scan intervals after last assessment were censored at date of last tumor assessment. Participants with no post baseline assessment or tumor progression but death reported within 2 scan intervals after randomization were censored at date of death.
Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD
BOR was defined as the best response across all time points from randomization until radiologically confirmed PD using RECIST, v1.1 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 a ≥30% decrease in sum of LD of target lesions. PD was defined as having a ≥20% increase in sum of LD of target lesions and ≥5 mm increase above nadir. SD was defined as small changes that did not meet above criteria.
Percentage of Participants With CR or PR (Objective Response Rate [ORR])
ORR was the percentage of participants who had CR or PR defined using RECIST v1.1 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 a ≥30% decrease in sum of LD of target lesions. Percentage of participants calculated as: (number of participants with CR + PR)/(total number of participants)*100.
Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity)
Participants who developed treatment-emergent antibody responses to Ramucirumab (IMC-1121B) after baseline.
Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion
Cmax After 4th Ramucirumab (IMC-1211B) Infusion
Cmax After 7th Ramucirumab (IMC-1211B) Infusion
Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion
This outcome measure was included in error as the time point was before ramucirumab (IMC-1211B) was administered. Cmin was not analyzed.
Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion
Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion
Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status
EORTC QLQ-C30 v3.0 is a 30-item, self-administered questionnaire with multidimensional scales assessing 15 domains (5 functional domains [physical, role, cognitive, emotional, and social], 9 symptom scales [fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties] and global health status scale). 28 questions assessed on a 1 (not at all) to 4 (very much) scale and the remaining 2 questions used a 1 (poor) to 7 (excellent) scale. 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 symptoms scales, higher scores represented a greater degree of symptoms.
Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score
The EQ-5D is a generic, multidimensional, health status instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale [1 (no problem), 2 (some problems), and 3 (major problems)]. These combinations of responses 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.

Full Information

First Posted
July 21, 2010
Last Updated
September 6, 2019
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01170663
Brief Title
A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma
Acronym
RAINBOW
Official Title
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared to paclitaxel plus placebo.
Detailed Description
The aim of this study is to determine if paclitaxel given together with ramucirumab (IMC-1211B) as second line therapy will prolong overall survival (OS) compared to paclitaxel alone. Approximately 663 participants (at least 18 years) in approximately 200 study centers and in approximately 30 countries will be randomized with histologically or cytologically confirmed metastatic gastric or gastroesophageal junction adenocarcinoma. Participants must have received at least one cycle of first line therapy with any platinum/fluoropyrimidine doublet with or without anthracycline (epirubicin or doxorubicin) and must have discontinued this therapy prior to study entry due to disease progression. Upon registration and completion of screening procedure and reviewing the Inclusion and Exclusion Criteria eligible participants will be randomized to receive either paclitaxel plus ramucirumab or paclitaxel plus placebo. Ramucirumab (IMC-1211B) DP/placebo will be administered IV on Days 1 and 15, paclitaxel will be administered IV on Days 1, 8 and 15 of a 4 weekly cycle. Participants will be continuously treated and monitored until radiographic or symptomatic progression of disease, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Metastatic Adenocarcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
665 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ramucirumab (IMC-1211B) Drug Product (DP) and Paclitaxel
Arm Type
Experimental
Arm Description
Ramucirumab (IMC-1211B) DP and Paclitaxel
Arm Title
Placebo and Paclitaxel
Arm Type
Placebo Comparator
Arm Description
Placebo and Paclitaxel
Intervention Type
Biological
Intervention Name(s)
Ramucirumab (IMC-1211B) DP
Other Intervention Name(s)
LY3009806, IMC-1211B
Intervention Description
8 milligrams/kilogram (mg/kg) intravenous (IV) infusion on Days 1 and 15 of every 4-week cycle
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Ramucirumab placebo IV infusion on Days 1 and 15 of every 4-week cycle
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 80 milligrams per square meter (mg/m²) IV infusion on Days 1, 8, and 15 of every 4-week cycle
Primary Outcome Measure Information:
Title
Overall Survival Time (OS)
Description
OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.
Time Frame
Randomization up to 27.5 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS was measured from date of randomization to first radiographically documented progressive disease (PD) or death due to any cause. PD defined using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Participants who had no baseline or post baseline radiological tumor assessment were censored at date of randomization. Participants who had no tumor progression or death within 2 scan intervals following the last assessment were censored at the date of last radiographic tumor assessment. Participants who began new anticancer treatment and had no tumor progression were censored at date of assessment prior to initiation of new therapy. Participants lost to follow-up or withdrew consent were censored at the date of their last assessment.
Time Frame
Randomization up to 22.2 months
Title
Time to Progressive Disease (TTP)
Description
TTP was defined as the time from randomization until date of radiographic progression using RECIST v1.1 criteria. PD was defined as having a ≥20% increase in sum of longest diameter (LD) of target lesions and at minimum 5 millimeters (mm) increase above nadir. Participants who did not progress or were lost to follow-up were censored at the date of last tumor assessment. Participants who had no baseline tumor assessment or no post baseline assessment and no death reported with 2 scan intervals post randomization were censored at date of randomization. Participants with no progression and not died within 2 scan intervals after last assessment were censored at date of last tumor assessment. Participants with no post baseline assessment or tumor progression but death reported within 2 scan intervals after randomization were censored at date of death.
Time Frame
Baseline up to 22.2 months
Title
Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD
Description
BOR was defined as the best response across all time points from randomization until radiologically confirmed PD using RECIST, v1.1 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 a ≥30% decrease in sum of LD of target lesions. PD was defined as having a ≥20% increase in sum of LD of target lesions and ≥5 mm increase above nadir. SD was defined as small changes that did not meet above criteria.
Time Frame
Randomization up to 22.2 months
Title
Percentage of Participants With CR or PR (Objective Response Rate [ORR])
Description
ORR was the percentage of participants who had CR or PR defined using RECIST v1.1 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 a ≥30% decrease in sum of LD of target lesions. Percentage of participants calculated as: (number of participants with CR + PR)/(total number of participants)*100.
Time Frame
Randomization up to 22.2 months
Title
Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity)
Description
Participants who developed treatment-emergent antibody responses to Ramucirumab (IMC-1121B) after baseline.
Time Frame
Prior to and after ramucirumab (IMC-1121B) infusion: Day 1 Cycles 1, 2 and 3 (28-day cycles) Doses 1, 4, 7 and 30-37 days after last dose of study therapy up to 103 weeks
Title
Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion
Time Frame
Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles)
Title
Cmax After 4th Ramucirumab (IMC-1211B) Infusion
Time Frame
Cycle 2, Day 15 1 hour post end of infusion (28-day cycles)
Title
Cmax After 7th Ramucirumab (IMC-1211B) Infusion
Time Frame
Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles)
Title
Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion
Description
This outcome measure was included in error as the time point was before ramucirumab (IMC-1211B) was administered. Cmin was not analyzed.
Time Frame
Cycle 1, Day 1 predose (28-day cycles)
Title
Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion
Time Frame
Cycle 2, Day 15 (28-day cycle)
Title
Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion
Time Frame
Cycle 4, Day 1 (28-day cycles)
Title
Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status
Description
EORTC QLQ-C30 v3.0 is a 30-item, self-administered questionnaire with multidimensional scales assessing 15 domains (5 functional domains [physical, role, cognitive, emotional, and social], 9 symptom scales [fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties] and global health status scale). 28 questions assessed on a 1 (not at all) to 4 (very much) scale and the remaining 2 questions used a 1 (poor) to 7 (excellent) scale. 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 symptoms scales, higher scores represented a greater degree of symptoms.
Time Frame
Baseline, end of therapy (up to 103 weeks)
Title
Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score
Description
The EQ-5D is a generic, multidimensional, health status instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale [1 (no problem), 2 (some problems), and 3 (major problems)]. These combinations of responses 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, end of therapy (up to 103 weeks)
Other Pre-specified Outcome Measures:
Title
Number of Participants With Serious and Other Non-serious Adverse Events (AE) and Who Died
Description
Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Time Frame
Baseline up to 103 weeks and within 30 days of last dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma Metastatic disease or locally advanced, unresectable disease Disease progression during or within 4 months after the last dose of the first-line therapy (platinum/fluoropyrimidine doublet with or without anthracycline) Organs are functioning well (liver, kidney, blood) Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1 Exclusion Criteria: First line chemotherapy for metastatic gastric cancer other than platinum/fluoropyrimidine doublet with or without anthracycline Previous systemic therapy with other anti-angiogenic drugs Uncontrolled high blood pressure Symptomatic or poorly controlled heart disease or had a heart attack or stroke within the last 6 month Evidence of central nervous system (CNS) metastasis at baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
ImClone Investigational Site
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
ImClone Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
ImClone Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
ImClone Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
ImClone Investigational Site
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
ImClone Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
ImClone Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
ImClone Investigational Site
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
ImClone Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
ImClone Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
ImClone Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
ImClone Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
ImClone Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
ImClone Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1019ABS
Country
Argentina
Facility Name
ImClone Investigational Site
City
Caba
ZIP/Postal Code
C1050AAK
Country
Argentina
Facility Name
ImClone Investigational Site
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
ImClone Investigational Site
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Facility Name
ImClone Investigational Site
City
Bankstown
State/Province
New South Wales
ZIP/Postal Code
2200
Country
Australia
Facility Name
ImClone Investigational Site
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
ImClone Investigational Site
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
ImClone Investigational Site
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
ImClone Investigational Site
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
ImClone Investigational Site
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
ImClone Investigational Site
City
Coburg
State/Province
Victoria
ZIP/Postal Code
3058
Country
Australia
Facility Name
ImClone Investigational Site
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
ImClone Investigational Site
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
ImClone Investigational Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
ImClone Investigational Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
ImClone Investigational Site
City
Linz
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
ImClone Investigational Site
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Facility Name
ImClone Investigational Site
City
Vienna
ZIP/Postal Code
1100
Country
Austria
Facility Name
ImClone Investigational Site
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
ImClone Investigational Site
City
Brugge
ZIP/Postal Code
8310
Country
Belgium
Facility Name
ImClone Investigational Site
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
ImClone Investigational Site
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
ImClone Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
ImClone Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
ImClone Investigational Site
City
Belo Horizonte
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
ImClone Investigational Site
City
Belo Horizonte
ZIP/Postal Code
30150-281
Country
Brazil
Facility Name
ImClone Investigational Site
City
Caxias Do Sul
ZIP/Postal Code
95070560
Country
Brazil
Facility Name
ImClone Investigational Site
City
Dois Lajeados
ZIP/Postal Code
95900-000
Country
Brazil
Facility Name
ImClone Investigational Site
City
Gavea
ZIP/Postal Code
22451-010
Country
Brazil
Facility Name
ImClone Investigational Site
City
Ijui
ZIP/Postal Code
98700 000
Country
Brazil
Facility Name
ImClone Investigational Site
City
Itajai
ZIP/Postal Code
88301-170
Country
Brazil
Facility Name
ImClone Investigational Site
City
Londrina
ZIP/Postal Code
86050-190
Country
Brazil
Facility Name
ImClone Investigational Site
City
Passo Fundo
ZIP/Postal Code
99010-260
Country
Brazil
Facility Name
ImClone Investigational Site
City
Porto Alegre-Rs
ZIP/Postal Code
90020090
Country
Brazil
Facility Name
ImClone Investigational Site
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
ImClone Investigational Site
City
Ribeirão Preto
ZIP/Postal Code
14015-130
Country
Brazil
Facility Name
ImClone Investigational Site
City
Rio De Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
ImClone Investigational Site
City
Salvador
ZIP/Postal Code
41820-021
Country
Brazil
Facility Name
ImClone Investigational Site
City
Sao Jose Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
ImClone Investigational Site
City
Sorocaba
ZIP/Postal Code
18031-000
Country
Brazil
Facility Name
ImClone Investigational Site
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
ImClone Investigational Site
City
São Paulo
ZIP/Postal Code
04122-000
Country
Brazil
Facility Name
ImClone Investigational Site
City
São Paulo
Country
Brazil
Facility Name
ImClone Investigational Site
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
ImClone Investigational Site
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
ImClone Investigational Site
City
Providencia
Country
Chile
Facility Name
ImClone Investigational Site
City
Vina Del Mar
Country
Chile
Facility Name
ImClone Investigational Site
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
ImClone Investigational Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
ImClone Investigational Site
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
ImClone Investigational Site
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
ImClone Investigational Site
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
ImClone Investigational Site
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
ImClone Investigational Site
City
Montbeliard
ZIP/Postal Code
25200
Country
France
Facility Name
ImClone Investigational Site
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
ImClone Investigational Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
ImClone Investigational Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
ImClone Investigational Site
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
ImClone Investigational Site
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
ImClone Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
ImClone Investigational Site
City
Bielefeld
ZIP/Postal Code
33611
Country
Germany
Facility Name
ImClone Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
ImClone Investigational Site
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
ImClone Investigational Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
ImClone Investigational Site
City
Hamburg
ZIP/Postal Code
22087
Country
Germany
Facility Name
ImClone Investigational Site
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
ImClone Investigational Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
ImClone Investigational Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
ImClone Investigational Site
City
Munich
ZIP/Postal Code
81737
Country
Germany
Facility Name
ImClone Investigational Site
City
Recklinghausen
ZIP/Postal Code
45657
Country
Germany
Facility Name
ImClone Investigational Site
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
ImClone Investigational Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
ImClone Investigational Site
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
ImClone Investigational Site
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
ImClone Investigational Site
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
ImClone Investigational Site
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
ImClone Investigational Site
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
ImClone Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
ImClone Investigational Site
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
ImClone Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
ImClone Investigational Site
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
ImClone Investigational Site
City
Tel Hashomer
ZIP/Postal Code
52661
Country
Israel
Facility Name
ImClone Investigational Site
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
ImClone Investigational Site
City
Ancona
ZIP/Postal Code
60100
Country
Italy
Facility Name
ImClone Investigational Site
City
Bari
ZIP/Postal Code
70126
Country
Italy
Facility Name
ImClone Investigational Site
City
Bergamo
ZIP/Postal Code
24125
Country
Italy
Facility Name
ImClone Investigational Site
City
Catania
ZIP/Postal Code
95122
Country
Italy
Facility Name
ImClone Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
ImClone Investigational Site
City
Milano
ZIP/Postal Code
20121
Country
Italy
Facility Name
ImClone Investigational Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
ImClone Investigational Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
ImClone Investigational Site
City
Torino
ZIP/Postal Code
10100
Country
Italy
Facility Name
ImClone Investigational Site
City
Aichi
ZIP/Postal Code
464
Country
Japan
Facility Name
ImClone Investigational Site
City
Chiba
ZIP/Postal Code
277 8577
Country
Japan
Facility Name
ImClone Investigational Site
City
Ehime
ZIP/Postal Code
790-0007
Country
Japan
Facility Name
ImClone Investigational Site
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
ImClone Investigational Site
City
Hokkaido
ZIP/Postal Code
060-0814
Country
Japan
Facility Name
ImClone Investigational Site
City
Kochi
ZIP/Postal Code
781-8555
Country
Japan
Facility Name
ImClone Investigational Site
City
Oita
ZIP/Postal Code
8795593
Country
Japan
Facility Name
ImClone Investigational Site
City
Osaka-Pref
ZIP/Postal Code
589
Country
Japan
Facility Name
ImClone Investigational Site
City
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
ImClone Investigational Site
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
ImClone Investigational Site
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
ImClone Investigational Site
City
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
ImClone Investigational Site
City
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
ImClone Investigational Site
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
ImClone Investigational Site
City
Seongnam-Si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
ImClone Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
ImClone Investigational Site
City
Suwon-City
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
ImClone Investigational Site
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
ImClone Investigational Site
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
ImClone Investigational Site
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
ImClone Investigational Site
City
Juchitan
ZIP/Postal Code
70000
Country
Mexico
Facility Name
ImClone Investigational Site
City
Nuevo Leon
ZIP/Postal Code
64060
Country
Mexico
Facility Name
ImClone Investigational Site
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
ImClone Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-769
Country
Poland
Facility Name
ImClone Investigational Site
City
Gdansk
ZIP/Postal Code
80-210
Country
Poland
Facility Name
ImClone Investigational Site
City
Lodz
ZIP/Postal Code
93-509
Country
Poland
Facility Name
ImClone Investigational Site
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
ImClone Investigational Site
City
Poznan
ZIP/Postal Code
61- 485
Country
Poland
Facility Name
ImClone Investigational Site
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
ImClone Investigational Site
City
Aveiro
ZIP/Postal Code
3814-501
Country
Portugal
Facility Name
ImClone Investigational Site
City
Coimbra
ZIP/Postal Code
3001-651
Country
Portugal
Facility Name
ImClone Investigational Site
City
Evora
ZIP/Postal Code
7000-811
Country
Portugal
Facility Name
ImClone Investigational Site
City
Porto
ZIP/Postal Code
4202-451
Country
Portugal
Facility Name
ImClone Investigational Site
City
Santa Maria Da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
ImClone Investigational Site
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
Facility Name
ImClone Investigational Site
City
Bucharest
Country
Romania
Facility Name
ImClone Investigational Site
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
ImClone Investigational Site
City
Targu Mures
ZIP/Postal Code
540072
Country
Romania
Facility Name
ImClone Investigational Site
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
Perm
ZIP/Postal Code
614066
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
Saint Petersburg
ZIP/Postal Code
191025
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
Singapore
ZIP/Postal Code
258499
Country
Singapore
Facility Name
ImClone Investigational Site
City
Avila
ZIP/Postal Code
05004
Country
Spain
Facility Name
ImClone Investigational Site
City
Burgos
ZIP/Postal Code
9005
Country
Spain
Facility Name
ImClone Investigational Site
City
Jerez De La Frontera
ZIP/Postal Code
11407
Country
Spain
Facility Name
ImClone Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
ImClone Investigational Site
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
ImClone Investigational Site
City
Palma De Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
ImClone Investigational Site
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
ImClone Investigational Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
ImClone Investigational Site
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
ImClone Investigational Site
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
ImClone Investigational Site
City
Liouying/Tainan
ZIP/Postal Code
736
Country
Taiwan
Facility Name
ImClone Investigational Site
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
ImClone Investigational Site
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
ImClone Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
ImClone Investigational Site
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
ImClone Investigational Site
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
ImClone Investigational Site
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
ImClone Investigational Site
City
Wolverhampton
State/Province
West Midlands
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
34795131
Citation
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.
Results Reference
derived
PubMed Identifier
33355909
Citation
Yamaguchi K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Omuro Y, Tamura T, Piao Y, Homma G, Jen MH, Liepa AM, Muro K. Quality of Life Associated with Ramucirumab Treatment in Patients with Advanced Gastric Cancer in Japan: Exploratory Analysis from the Phase III RAINBOW Trial. Clin Drug Investig. 2021 Jan;41(1):53-64. doi: 10.1007/s40261-020-00979-3. Epub 2020 Dec 23.
Results Reference
derived
PubMed Identifier
33274542
Citation
Cascinu S, Bodoky G, Muro K, Van Cutsem E, Oh SC, Folprecht G, Ananda S, Girotto G, Wainberg ZA, Miron MLL, Ajani J, Wei R, Liepa AM, Carlesi R, Emig M, Ohtsu A. Tumor Response and Symptom Palliation from RAINBOW, a Phase III Trial of Ramucirumab Plus Paclitaxel in Previously Treated Advanced Gastric Cancer. Oncologist. 2021 Mar;26(3):e414-e424. doi: 10.1002/onco.13623. Epub 2020 Dec 23.
Results Reference
derived
PubMed Identifier
31234645
Citation
De Vita F, Borg C, Farina G, Geva R, Carton I, Cuku H, Wei R, Muro K. Ramucirumab and paclitaxel in patients with gastric cancer and prior trastuzumab: subgroup analysis from RAINBOW study. Future Oncol. 2019 Aug;15(23):2723-2731. doi: 10.2217/fon-2019-0243. Epub 2019 Jun 25. Erratum In: Future Oncol. 2021 Sep;17(25):3409.
Results Reference
derived
PubMed Identifier
30557792
Citation
Chau I, Fuchs CS, Ohtsu A, Barzi A, Liepa AM, Cui ZL, Hsu Y, Al-Batran SE. Association of quality of life with disease characteristics and treatment outcomes in patients with advanced gastric cancer: Exploratory analysis of RAINBOW and REGARD phase III trials. Eur J Cancer. 2019 Jan;107:115-123. doi: 10.1016/j.ejca.2018.11.013. Epub 2018 Dec 14.
Results Reference
derived
PubMed Identifier
28716815
Citation
Tabernero J, Ohtsu A, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Ajani JA, Tomasek J, Safran H, Chandrawansa K, Hsu Y, Heathman M, Khan A, Ni L, Melemed AS, Gao L, Ferry D, Fuchs CS. Exposure-Response Analyses of Ramucirumab from Two Randomized, Phase III Trials of Second-line Treatment for Advanced Gastric or Gastroesophageal Junction Cancer. Mol Cancer Ther. 2017 Oct;16(10):2215-2222. doi: 10.1158/1535-7163.MCT-16-0895. Epub 2017 Jul 17.
Results Reference
derived
PubMed Identifier
26747859
Citation
Al-Batran SE, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov ON, Kim TY, Cunningham D, Rougier P, Muro K, Liepa AM, Chandrawansa K, Emig M, Ohtsu A, Wilke H. Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. Ann Oncol. 2016 Apr;27(4):673-9. doi: 10.1093/annonc/mdv625. Epub 2016 Jan 7.
Results Reference
derived
PubMed Identifier
26510663
Citation
Shitara K, Muro K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Yamaguchi K, Segawa Y, Omuro Y, Tamura T, Doi T, Yukisawa S, Yasui H, Nagashima F, Gotoh M, Esaki T, Emig M, Chandrawansa K, Liepa AM, Wilke H, Ichimiya Y, Ohtsu A. Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer. Gastric Cancer. 2016 Jul;19(3):927-38. doi: 10.1007/s10120-015-0559-z. Epub 2015 Oct 28.
Results Reference
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PubMed Identifier
25240821
Citation
Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.
Results Reference
derived

Learn more about this trial

A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma

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