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

September 6, 2019 updated by: Eli Lilly and Company

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

665

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, C1019ABS
        • ImClone Investigational Site
      • Caba, Argentina, C1050AAK
        • ImClone Investigational Site
      • Rosario, Argentina, 2000
        • ImClone Investigational Site
      • Santa Fe, Argentina, 3000
        • ImClone Investigational Site
    • New South Wales
      • Bankstown, New South Wales, Australia, 2200
        • ImClone Investigational Site
      • Kogarah, New South Wales, Australia, 2217
        • ImClone Investigational Site
      • Liverpool, New South Wales, Australia, 2170
        • ImClone Investigational Site
      • Wollongong, New South Wales, Australia, 2500
        • ImClone Investigational Site
    • Queensland
      • Southport, Queensland, Australia, 4215
        • ImClone Investigational Site
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • ImClone Investigational Site
    • Victoria
      • Coburg, Victoria, Australia, 3058
        • ImClone Investigational Site
      • Footscray, Victoria, Australia, 3011
        • ImClone Investigational Site
      • Frankston, Victoria, Australia, 3199
        • ImClone Investigational Site
      • Parkville, Victoria, Australia, 3050
        • ImClone Investigational Site
      • Graz, Austria, 8036
        • ImClone Investigational Site
      • Linz, Austria, A-4010
        • ImClone Investigational Site
      • Steyr, Austria, 4400
        • ImClone Investigational Site
      • Vienna, Austria, 1100
        • ImClone Investigational Site
      • Bonheiden, Belgium, 2820
        • ImClone Investigational Site
      • Brugge, Belgium, 8310
        • ImClone Investigational Site
      • Brussels, Belgium, 1000
        • ImClone Investigational Site
      • Brussels, Belgium, 1070
        • ImClone Investigational Site
      • Edegem, Belgium, 2650
        • ImClone Investigational Site
      • Leuven, Belgium, 3000
        • ImClone Investigational Site
      • Belo Horizonte, Brazil, 30130-100
        • ImClone Investigational Site
      • Belo Horizonte, Brazil, 30150-281
        • ImClone Investigational Site
      • Caxias Do Sul, Brazil, 95070560
        • ImClone Investigational Site
      • Dois Lajeados, Brazil, 95900-000
        • ImClone Investigational Site
      • Gavea, Brazil, 22451-010
        • ImClone Investigational Site
      • Ijui, Brazil, 98700 000
        • ImClone Investigational Site
      • Itajai, Brazil, 88301-170
        • ImClone Investigational Site
      • Londrina, Brazil, 86050-190
        • ImClone Investigational Site
      • Passo Fundo, Brazil, 99010-260
        • ImClone Investigational Site
      • Porto Alegre, Brazil, 90035-903
        • ImClone Investigational Site
      • Porto Alegre-Rs, Brazil, 90020090
        • ImClone Investigational Site
      • Ribeirão Preto, Brazil, 14015-130
        • ImClone Investigational Site
      • Rio De Janeiro, Brazil, 20231-050
        • ImClone Investigational Site
      • Salvador, Brazil, 41820-021
        • ImClone Investigational Site
      • Sao Jose Rio Preto, Brazil, 15090-000
        • ImClone Investigational Site
      • Sorocaba, Brazil, 18031-000
        • ImClone Investigational Site
      • São Paulo, Brazil, 01246-000
        • ImClone Investigational Site
      • São Paulo, Brazil, 04122-000
        • ImClone Investigational Site
      • São Paulo, Brazil
        • ImClone Investigational Site
      • Sofia, Bulgaria, 1756
        • ImClone Investigational Site
      • Varna, Bulgaria, 9000
        • ImClone Investigational Site
      • Providencia, Chile
        • ImClone Investigational Site
      • Vina Del Mar, Chile
        • ImClone Investigational Site
      • Tallinn, Estonia, 10138
        • ImClone Investigational Site
      • Tallinn, Estonia, 13419
        • ImClone Investigational Site
      • Besancon, France, 25030
        • ImClone Investigational Site
      • Brest, France, 29609
        • ImClone Investigational Site
      • Clermont-Ferrand, France, 63003
        • ImClone Investigational Site
      • Marseille, France, 13385
        • ImClone Investigational Site
      • Montbeliard, France, 25200
        • ImClone Investigational Site
      • Montpellier, France, 34298
        • ImClone Investigational Site
      • Paris, France, 75013
        • ImClone Investigational Site
      • Paris, France, 75015
        • ImClone Investigational Site
      • Paris, France, 75475
        • ImClone Investigational Site
      • Saint-Etienne, France, 42055
        • ImClone Investigational Site
      • Berlin, Germany, 13353
        • ImClone Investigational Site
      • Bielefeld, Germany, 33611
        • ImClone Investigational Site
      • Dresden, Germany, 01307
        • ImClone Investigational Site
      • Essen, Germany, 45136
        • ImClone Investigational Site
      • Frankfurt, Germany, 60596
        • ImClone Investigational Site
      • Hamburg, Germany, 22087
        • ImClone Investigational Site
      • Heidelberg, Germany, 69115
        • ImClone Investigational Site
      • Leipzig, Germany, 04103
        • ImClone Investigational Site
      • Mainz, Germany, 55131
        • ImClone Investigational Site
      • Munich, Germany, 81737
        • ImClone Investigational Site
      • Recklinghausen, Germany, 45657
        • ImClone Investigational Site
      • Tuebingen, Germany, 72076
        • ImClone Investigational Site
      • Budapest, Hungary, 1125
        • ImClone Investigational Site
      • Gyula, Hungary, 5700
        • ImClone Investigational Site
      • Kaposvar, Hungary, 7400
        • ImClone Investigational Site
      • Pecs, Hungary, 7624
        • ImClone Investigational Site
      • Szekesfehervar, Hungary, 8000
        • ImClone Investigational Site
      • Beer Sheva, Israel, 84101
        • ImClone Investigational Site
      • Haifa, Israel, 31096
        • ImClone Investigational Site
      • Holon, Israel, 58100
        • ImClone Investigational Site
      • Jerusalem, Israel, 91120
        • ImClone Investigational Site
      • Petah Tikva, Israel, 49100
        • ImClone Investigational Site
      • Tel Hashomer, Israel, 52661
        • ImClone Investigational Site
      • Tel-Aviv, Israel, 64239
        • ImClone Investigational Site
      • Ancona, Italy, 60100
        • ImClone Investigational Site
      • Bari, Italy, 70126
        • ImClone Investigational Site
      • Bergamo, Italy, 24125
        • ImClone Investigational Site
      • Catania, Italy, 95122
        • ImClone Investigational Site
      • Genova, Italy, 16132
        • ImClone Investigational Site
      • Milano, Italy, 20121
        • ImClone Investigational Site
      • Padova, Italy, 35128
        • ImClone Investigational Site
      • Pisa, Italy, 56126
        • ImClone Investigational Site
      • Torino, Italy, 10100
        • ImClone Investigational Site
      • Aichi, Japan, 464
        • ImClone Investigational Site
      • Chiba, Japan, 277 8577
        • ImClone Investigational Site
      • Ehime, Japan, 790-0007
        • ImClone Investigational Site
      • Fukuoka, Japan, 811-1395
        • ImClone Investigational Site
      • Hokkaido, Japan, 060-0814
        • ImClone Investigational Site
      • Kochi, Japan, 781-8555
        • ImClone Investigational Site
      • Oita, Japan, 8795593
        • ImClone Investigational Site
      • Osaka, Japan, 569-8686
        • ImClone Investigational Site
      • Osaka-Pref, Japan, 589
        • ImClone Investigational Site
      • Saitama, Japan, 362-0806
        • ImClone Investigational Site
      • Shizuoka, Japan, 411-8777
        • ImClone Investigational Site
      • Tochigi, Japan, 320-0834
        • ImClone Investigational Site
      • Tokyo, Japan, 181-8611
        • ImClone Investigational Site
      • Incheon, Korea, Republic of, 405-760
        • ImClone Investigational Site
      • Seongnam-Si, Korea, Republic of, 463-707
        • ImClone Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • ImClone Investigational Site
      • Suwon, Korea, Republic of, 443-721
        • ImClone Investigational Site
      • Suwon-City, Korea, Republic of, 442-723
        • ImClone Investigational Site
      • Kaunas, Lithuania, LT-50009
        • ImClone Investigational Site
      • Klaipeda, Lithuania, LT-92288
        • ImClone Investigational Site
      • Juchitan, Mexico, 70000
        • ImClone Investigational Site
      • Nuevo Leon, Mexico, 64060
        • ImClone Investigational Site
      • Brzozow, Poland, 36-200
        • ImClone Investigational Site
      • Bydgoszcz, Poland, 85-769
        • ImClone Investigational Site
      • Gdansk, Poland, 80-210
        • ImClone Investigational Site
      • Lodz, Poland, 93-509
        • ImClone Investigational Site
      • Lublin, Poland, 20-090
        • ImClone Investigational Site
      • Poznan, Poland, 61- 485
        • ImClone Investigational Site
      • Warsaw, Poland, 02-781
        • ImClone Investigational Site
      • Aveiro, Portugal, 3814-501
        • ImClone Investigational Site
      • Coimbra, Portugal, 3001-651
        • ImClone Investigational Site
      • Evora, Portugal, 7000-811
        • ImClone Investigational Site
      • Porto, Portugal, 4202-451
        • ImClone Investigational Site
      • Santa Maria Da Feira, Portugal, 4520-211
        • ImClone Investigational Site
      • Baia Mare, Romania, 430031
        • ImClone Investigational Site
      • Bucharest, Romania
        • ImClone Investigational Site
      • Iasi, Romania, 700106
        • ImClone Investigational Site
      • Targu Mures, Romania, 540072
        • ImClone Investigational Site
      • Krasnodar, Russian Federation, 350040
        • ImClone Investigational Site
      • Moscow, Russian Federation, 115478
        • ImClone Investigational Site
      • Perm, Russian Federation, 614066
        • ImClone Investigational Site
      • Saint Petersburg, Russian Federation, 191025
        • ImClone Investigational Site
      • Ufa, Russian Federation, 450054
        • ImClone Investigational Site
      • Singapore, Singapore, 258499
        • ImClone Investigational Site
      • Avila, Spain, 05004
        • ImClone Investigational Site
      • Burgos, Spain, 9005
        • ImClone Investigational Site
      • Jerez De La Frontera, Spain, 11407
        • ImClone Investigational Site
      • Madrid, Spain, 28041
        • ImClone Investigational Site
      • Majadahonda, Spain, 28222
        • ImClone Investigational Site
      • Palma De Mallorca, Spain, 07014
        • ImClone Investigational Site
      • Sabadell, Spain, 08208
        • ImClone Investigational Site
      • Sevilla, Spain, 41009
        • ImClone Investigational Site
      • Changhua, Taiwan, 500
        • ImClone Investigational Site
      • Kaohsiung, Taiwan, 833
        • ImClone Investigational Site
      • Liouying/Tainan, Taiwan, 736
        • ImClone Investigational Site
      • Taichung, Taiwan, 404
        • ImClone Investigational Site
      • Tainan, Taiwan, 70403
        • ImClone Investigational Site
      • Taipei, Taiwan, 112
        • ImClone Investigational Site
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • ImClone Investigational Site
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • ImClone Investigational Site
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • ImClone Investigational Site
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
        • ImClone Investigational Site
    • California
      • Burbank, California, United States, 91505
        • ImClone Investigational Site
      • Los Angeles, California, United States, 90095
        • ImClone Investigational Site
      • San Francisco, California, United States, 94115
        • ImClone Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32207
        • ImClone Investigational Site
      • Miramar, Florida, United States, 33027
        • ImClone Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • ImClone Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • ImClone Investigational Site
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • ImClone Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • ImClone Investigational Site
    • New York
      • New York, New York, United States, 10016
        • ImClone Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • ImClone Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • ImClone Investigational Site
    • Washington
      • Seattle, Washington, United States, 98109
        • ImClone Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ramucirumab (IMC-1211B) Drug Product (DP) and Paclitaxel
Ramucirumab (IMC-1211B) DP and Paclitaxel
8 milligrams/kilogram (mg/kg) intravenous (IV) infusion on Days 1 and 15 of every 4-week cycle
Other Names:
  • LY3009806
  • IMC-1211B
Paclitaxel 80 milligrams per square meter (mg/m²) IV infusion on Days 1, 8, and 15 of every 4-week cycle
Placebo Comparator: Placebo and Paclitaxel
Paclitaxel 80 milligrams per square meter (mg/m²) IV infusion on Days 1, 8, and 15 of every 4-week cycle
Ramucirumab placebo IV infusion on Days 1 and 15 of every 4-week cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival Time (OS)
Time Frame: Randomization up to 27.5 months
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.
Randomization up to 27.5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Randomization up to 22.2 months
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.
Randomization up to 22.2 months
Time to Progressive Disease (TTP)
Time Frame: Baseline up to 22.2 months
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.
Baseline up to 22.2 months
Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD
Time Frame: Randomization up to 22.2 months
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.
Randomization up to 22.2 months
Percentage of Participants With CR or PR (Objective Response Rate [ORR])
Time Frame: Randomization up to 22.2 months
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.
Randomization up to 22.2 months
Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity)
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
Participants who developed treatment-emergent antibody responses to Ramucirumab (IMC-1121B) after baseline.
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
Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion
Time Frame: Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles)
Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles)
Cmax After 4th Ramucirumab (IMC-1211B) Infusion
Time Frame: Cycle 2, Day 15 1 hour post end of infusion (28-day cycles)
Cycle 2, Day 15 1 hour post end of infusion (28-day cycles)
Cmax After 7th Ramucirumab (IMC-1211B) Infusion
Time Frame: Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles)
Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles)
Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion
Time Frame: Cycle 1, Day 1 predose (28-day cycles)
This outcome measure was included in error as the time point was before ramucirumab (IMC-1211B) was administered. Cmin was not analyzed.
Cycle 1, Day 1 predose (28-day cycles)
Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion
Time Frame: Cycle 2, Day 15 (28-day cycle)
Cycle 2, Day 15 (28-day cycle)
Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion
Time Frame: Cycle 4, Day 1 (28-day cycles)
Cycle 4, Day 1 (28-day cycles)
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
Time Frame: Baseline, end of therapy (up to 103 weeks)
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.
Baseline, end of therapy (up to 103 weeks)
Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score
Time Frame: Baseline, end of therapy (up to 103 weeks)
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.
Baseline, end of therapy (up to 103 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Serious and Other Non-serious Adverse Events (AE) and Who Died
Time Frame: Baseline up to 103 weeks and within 30 days of last dose of study drug
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.
Baseline up to 103 weeks and within 30 days of last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

July 26, 2010

First Posted (Estimate)

July 27, 2010

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 6, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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 Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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