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Gastric CancerPhase 3RAINBOWNCT01170663

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

A Phase 3 study testing Ramucirumab (IMC-1211B) DP and Paclitaxel in people with Gastric Cancer, run by Eli Lilly and Company at 167 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Ramucirumab (IMC-1211B) DP and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
665 participants
Where
167 sitesin 26 countries
Study dates
Dec 2010to Feb 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

167 sites in 26 countries.

167 sites in 26 countries

Brazil19 sites

  • ImClone Investigational Site

    Belo Horizonte, 30130-100

  • ImClone Investigational Site

    Belo Horizonte, 30150-281

  • ImClone Investigational Site

    Caxias do Sul, 95070560

  • ImClone Investigational Site

    Dois Lajeados, 95900-000

  • ImClone Investigational Site

    Gávea, 22451-010

  • ImClone Investigational Site

    Ijuí, 98700 000

  • ImClone Investigational Site

    Itajaí, 88301-170

  • ImClone Investigational Site

    Londrina, 86050-190

  • ImClone Investigational Site

    Passo Fundo, 99010-260

  • ImClone Investigational Site

    Porto Alegre, 90035-903

  • ImClone Investigational Site

    Porto Alegre-Rs, 90020090

  • ImClone Investigational Site

    Ribeirão Preto, 14015-130

  • ImClone Investigational Site

    Rio de Janeiro, 20231-050

  • ImClone Investigational Site

    Salvador, 41820-021

  • ImClone Investigational Site

    Sao Jose Rio Preto, 15090-000

  • ImClone Investigational Site

    São Paulo, 01246-000

  • ImClone Investigational Site

    São Paulo, 04122-000

  • ImClone Investigational Site

    São Paulo

  • ImClone Investigational Site

    Sorocaba, 18031-000

Other trials in Brazil

United States13 sites

  • ImClone Investigational Site

    Albuquerque, New Mexico, 87131

  • ImClone Investigational Site

    Atlanta, Georgia, 30322

  • ImClone Investigational Site

    Burbank, California, 91505

  • ImClone Investigational Site

    Chattanooga, Tennessee, 37404

  • ImClone Investigational Site

    East Orange, New Jersey, 07018

  • ImClone Investigational Site

    Honolulu, Hawaii, 96813

  • ImClone Investigational Site

    Houston, Texas, 77030

  • ImClone Investigational Site

    Jacksonville, Florida, 32207

  • ImClone Investigational Site

    Los Angeles, California, 90095

  • ImClone Investigational Site

    Miramar, Florida, 33027

  • ImClone Investigational Site

    New York, New York, 10016

  • ImClone Investigational Site

    San Francisco, California, 94115

  • ImClone Investigational Site

    Seattle, Washington, 98109

Other trials in United States

Japan13 sites

  • ImClone Investigational Site

    Aichi, 464

  • ImClone Investigational Site

    Chiba, 277 8577

  • ImClone Investigational Site

    Ehime, 790-0007

  • ImClone Investigational Site

    Fukuoka, 811-1395

  • ImClone Investigational Site

    Hokkaido, 060-0814

  • ImClone Investigational Site

    Kochi, 781-8555

  • ImClone Investigational Site

    Ōita, 8795593

  • ImClone Investigational Site

    Osaka, 569-8686

  • ImClone Investigational Site

    Osaka-Pref, 589

  • ImClone Investigational Site

    Saitama, 362-0806

  • ImClone Investigational Site

    Shizuoka, 411-8777

  • ImClone Investigational Site

    Tochigi, 320-0834

  • ImClone Investigational Site

    Tokyo, 181-8611

Other trials in Japan

Germany12 sites

  • ImClone Investigational Site

    Berlin, 13353

  • ImClone Investigational Site

    Bielefeld, 33611

  • ImClone Investigational Site

    Dresden, 01307

  • ImClone Investigational Site

    Essen, 45136

  • ImClone Investigational Site

    Frankfurt, 60596

  • ImClone Investigational Site

    Hamburg, 22087

  • ImClone Investigational Site

    Heidelberg, 69115

  • ImClone Investigational Site

    Leipzig, 04103

  • ImClone Investigational Site

    Mainz, 55131

  • ImClone Investigational Site

    Munich, 81737

  • ImClone Investigational Site

    Recklinghausen, 45657

  • ImClone Investigational Site

    Tübingen, 72076

Other trials in Germany

Australia10 sites

  • ImClone Investigational Site

    Bankstown, New South Wales, 2200

  • ImClone Investigational Site

    Coburg, Victoria, 3058

  • ImClone Investigational Site

    Footscray, Victoria, 3011

  • ImClone Investigational Site

    Frankston, Victoria, 3199

  • ImClone Investigational Site

    Kogarah, New South Wales, 2217

  • ImClone Investigational Site

    Kurralta Park, South Australia, 5037

  • ImClone Investigational Site

    Liverpool, New South Wales, 2170

  • ImClone Investigational Site

    Parkville, Victoria, 3050

  • ImClone Investigational Site

    Southport, Queensland, 4215

  • ImClone Investigational Site

    Wollongong, New South Wales, 2500

Other trials in Australia

France10 sites

  • ImClone Investigational Site

    Besançon, 25030

  • ImClone Investigational Site

    Brest, 29609

  • ImClone Investigational Site

    Clermont-Ferrand, 63003

  • ImClone Investigational Site

    Marseille, 13385

  • ImClone Investigational Site

    Montbéliard, 25200

  • ImClone Investigational Site

    Montpellier, 34298

  • ImClone Investigational Site

    Paris, 75013

  • ImClone Investigational Site

    Paris, 75015

  • ImClone Investigational Site

    Paris, 75475

  • ImClone Investigational Site

    Saint-Etienne, 42055

Other trials in France

Italy9 sites

  • ImClone Investigational Site

    Ancona, 60100

  • ImClone Investigational Site

    Bari, 70126

  • ImClone Investigational Site

    Bergamo, 24125

  • ImClone Investigational Site

    Catania, 95122

  • ImClone Investigational Site

    Genova, 16132

  • ImClone Investigational Site

    Milan, 20121

  • ImClone Investigational Site

    Padova, 35128

  • ImClone Investigational Site

    Pisa, 56126

  • ImClone Investigational Site

    Torino, 10100

Other trials in Italy

Spain8 sites

  • ImClone Investigational Site

    Ávila, 05004

  • ImClone Investigational Site

    Burgos, 9005

  • ImClone Investigational Site

    Jerez de la Frontera, 11407

  • ImClone Investigational Site

    Madrid, 28041

  • ImClone Investigational Site

    Majadahonda, 28222

  • ImClone Investigational Site

    Palma de Mallorca, 07014

  • ImClone Investigational Site

    Sabadell, 08208

  • ImClone Investigational Site

    Seville, 41009

Other trials in Spain

Israel7 sites

  • ImClone Investigational Site

    Beersheba, 84101

  • ImClone Investigational Site

    Haifa, 31096

  • ImClone Investigational Site

    Holon, 58100

  • ImClone Investigational Site

    Jerusalem, 91120

  • ImClone Investigational Site

    Petah Tikva, 49100

  • ImClone Investigational Site

    Tel Aviv, 64239

  • ImClone Investigational Site

    Tel HaShomer, 52661

Other trials in Israel

Poland7 sites

  • ImClone Investigational Site

    Brzozów, 36-200

  • ImClone Investigational Site

    Bydgoszcz, 85-769

  • ImClone Investigational Site

    Gdansk, 80-210

  • ImClone Investigational Site

    Lodz, 93-509

  • ImClone Investigational Site

    Lublin, 20-090

  • ImClone Investigational Site

    Poznan, 61- 485

  • ImClone Investigational Site

    Warsaw, 02-781

Other trials in Poland

Belgium6 sites

  • ImClone Investigational Site

    Bonheiden, 2820

  • ImClone Investigational Site

    Bruges, 8310

  • ImClone Investigational Site

    Brussels, 1000

  • ImClone Investigational Site

    Brussels, 1070

  • ImClone Investigational Site

    Edegem, 2650

  • ImClone Investigational Site

    Leuven, 3000

Other trials in Belgium

Taiwan6 sites

  • ImClone Investigational Site

    Changhua, 500

  • ImClone Investigational Site

    Kaohsiung City, 833

  • ImClone Investigational Site

    Liouying/Tainan, 736

  • ImClone Investigational Site

    Taichung, 404

  • ImClone Investigational Site

    Tainan, 70403

  • ImClone Investigational Site

    Taipei, 112

Other trials in Taiwan

Hungary5 sites

  • ImClone Investigational Site

    Budapest, 1125

  • ImClone Investigational Site

    Gyula, 5700

  • ImClone Investigational Site

    Kaposvár, 7400

  • ImClone Investigational Site

    Pécs, 7624

  • ImClone Investigational Site

    Székesfehérvár, 8000

Other trials in Hungary

Portugal5 sites

  • ImClone Investigational Site

    Aveiro, 3814-501

  • ImClone Investigational Site

    Coimbra, 3001-651

  • ImClone Investigational Site

    Evora, 7000-811

  • ImClone Investigational Site

    Porto, 4202-451

  • ImClone Investigational Site

    Santa Maria da Feira, 4520-211

Other trials in Portugal

Russia5 sites

  • ImClone Investigational Site

    Krasnodar, 350040

  • ImClone Investigational Site

    Moscow, 115478

  • ImClone Investigational Site

    Perm, 614066

  • ImClone Investigational Site

    Saint Petersburg, 191025

  • ImClone Investigational Site

    Ufa, 450054

Other trials in Russia

South Korea5 sites

  • ImClone Investigational Site

    Incheon, 405-760

  • ImClone Investigational Site

    Seongnam-si, 463-707

  • ImClone Investigational Site

    Seoul, 110-744

  • ImClone Investigational Site

    Suwon, 442-723

  • ImClone Investigational Site

    Suwon, 443-721

Other trials in South Korea

Argentina4 sites

  • ImClone Investigational Site

    Buenos Aires, C1019ABS

  • ImClone Investigational Site

    Caba, C1050AAK

  • ImClone Investigational Site

    Rosario, 2000

  • ImClone Investigational Site

    Santa Fe, 3000

Other trials in Argentina

Austria4 sites

  • ImClone Investigational Site

    Graz, 8036

  • ImClone Investigational Site

    Linz, A-4010

  • ImClone Investigational Site

    Steyr, 4400

  • ImClone Investigational Site

    Vienna, 1100

Other trials in Austria

Romania4 sites

  • ImClone Investigational Site

    Baia Mare, 430031

  • ImClone Investigational Site

    Bucharest

  • ImClone Investigational Site

    Iași, 700106

  • ImClone Investigational Site

    Târgu Mureş, 540072

Other trials in Romania

United Kingdom4 sites

  • ImClone Investigational Site

    Guildford, Surrey, GU2 7XX

  • ImClone Investigational Site

    Maidstone, Kent, ME16 9QQ

  • ImClone Investigational Site

    Sutton, Surrey, SM2 5PT

  • ImClone Investigational Site

    Wolverhampton, West Midlands, WV10 0QP

Other trials in United Kingdom

Bulgaria2 sites

  • ImClone Investigational Site

    Sofia, 1756

  • ImClone Investigational Site

    Varna, 9000

Other trials in Bulgaria

Chile2 sites

  • ImClone Investigational Site

    Providencia

  • ImClone Investigational Site

    Viña del Mar

Other trials in Chile

Estonia2 sites

  • ImClone Investigational Site

    Tallinn, 10138

  • ImClone Investigational Site

    Tallinn, 13419

Other trials in Estonia

Lithuania2 sites

  • ImClone Investigational Site

    Kaunas, LT-50009

  • ImClone Investigational Site

    Klaipėda, LT-92288

Other trials in Lithuania

Mexico2 sites

  • ImClone Investigational Site

    Juchitán, 70000

  • ImClone Investigational Site

    Nuevo León, 64060

Other trials in Mexico

Singapore1 site

  • ImClone Investigational Site

    Singapore, 258499

Other trials in Singapore

About this study

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

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.

Read the 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.

Conditions
Gastric Cancer
Being tested
Ramucirumab (IMC-1211B) DP, Placebo, Paclitaxel
Keywords
Metastatic Adenocarcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Medical subject headings
Stomach Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ramucirumab (IMC-1211B) DPBiological

    Also called LY3009806, IMC-1211B

    8 milligrams/kilogram (mg/kg) intravenous (IV) infusion on Days 1 and 15 of every 4-week cycle

  • PlaceboDrug

    Ramucirumab placebo IV infusion on Days 1 and 15 of every 4-week cycle

  • PaclitaxelDrug

    Paclitaxel 80 milligrams per square meter (mg/m²) IV infusion on Days 1, 8, and 15 of every 4-week cycle

Study groups in NCT01170663
Study groupRoleWhat they receive
Ramucirumab (IMC-1211B) Drug Product (DP) and PaclitaxelExperimentalRamucirumab (IMC-1211B) DP and Paclitaxel
Receives: Biological: Ramucirumab (IMC-1211B) DP; Drug: Paclitaxel
Placebo and PaclitaxelPlacebo comparatorPlacebo and Paclitaxel
Receives: Drug: Placebo; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Randomization up to 27.5 months

Secondary outcomes (13)

  1. 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.

    Measured: Randomization up to 22.2 months

  2. 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.

    Measured: Baseline up to 22.2 months

  3. 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.

    Measured: Randomization up to 22.2 months

  4. 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.

    Measured: Randomization up to 22.2 months

  5. 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.

    Measured: 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

  6. Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion

    Measured: Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles)

  7. Cmax After 4th Ramucirumab (IMC-1211B) Infusion

    Measured: Cycle 2, Day 15 1 hour post end of infusion (28-day cycles)

  8. Cmax After 7th Ramucirumab (IMC-1211B) Infusion

    Measured: Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles)

  9. 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.

    Measured: Cycle 1, Day 1 predose (28-day cycles)

  10. Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion

    Measured: Cycle 2, Day 15 (28-day cycle)

  11. Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion

    Measured: Cycle 4, Day 1 (28-day cycles)

  12. 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.

    Measured: Baseline, end of therapy (up to 103 weeks)

  13. 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.

    Measured: Baseline, end of therapy (up to 103 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionJul 2013
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
665 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01170663
Sponsor's protocol ID
13894
Other IDs
I4T-IE-JVBE, CP12-0922, 2010-020426-18
Acronym
RAINBOW
Status last verified
Sep 2019
First submitted
21 Jul 2010
Last updated
18 Sep 2019
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • Ogata T, Narita Y, Wainberg ZA, Van Cutsem E, Yamaguchi K, Piao Y, Zhao Y, Peterson PM, Wijayawardana SR, Abada P, Chatterjee A, Muro K. Exploratory Analysis of Patients With Gastric/Gastroesophageal Junction Adenocarcinoma With or Without Liver Metastasis From the Phase 3 RAINBOW Study. J Gastric Cancer. 2023 Apr;23(2):289-302. doi: 10.5230/jgc.2023.23.e15.

    PubMed 37129153

  • 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.

    PubMed 34795131

  • 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.

    PubMed 33355909

  • 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.

    PubMed 33274542

  • 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.

    PubMed 31234645

  • 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.

    PubMed 30557792

  • 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.

    PubMed 28716815

  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ramucirumab (IMC-1211B) DP and Paclitaxel in people with Gastric Cancer, run by Eli Lilly and Company at 167 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in Brazil, United States, Japan, Germany, Australia and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival Time (OS) (time frame: Randomization up to 27.5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01170663, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.

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