A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma
RAINBOW
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
4 other identifiers
interventional
665
24 countries
149
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 gastric-cancer
Started Dec 2010
Typical duration for phase_3 gastric-cancer
149 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2010
CompletedFirst Posted
Study publicly available on registry
July 27, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedResults Posted
Study results publicly available
July 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedSeptember 18, 2019
September 1, 2019
2.6 years
July 21, 2010
July 1, 2014
September 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Randomization up to 27.5 months
Secondary Outcomes (13)
Progression-Free Survival (PFS)
Randomization up to 22.2 months
Time to Progressive Disease (TTP)
Baseline up to 22.2 months
Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD
Randomization up to 22.2 months
Percentage of Participants With CR or PR (Objective Response Rate [ORR])
Randomization up to 22.2 months
Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity)
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
- +8 more secondary outcomes
Other Outcomes (1)
Number of Participants With Serious and Other Non-serious Adverse Events (AE) and Who Died
Baseline up to 103 weeks and within 30 days of last dose of study drug
Study Arms (2)
Ramucirumab (IMC-1211B) Drug Product (DP) and Paclitaxel
EXPERIMENTALRamucirumab (IMC-1211B) DP and Paclitaxel
Placebo and Paclitaxel
PLACEBO COMPARATORPlacebo and Paclitaxel
Interventions
8 milligrams/kilogram (mg/kg) intravenous (IV) infusion on Days 1 and 15 of every 4-week cycle
Ramucirumab placebo IV infusion on Days 1 and 15 of every 4-week cycle
Paclitaxel 80 milligrams per square meter (mg/m²) IV infusion on Days 1, 8, and 15 of every 4-week cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (167)
ImClone Investigational Site
Burbank, California, 91505, United States
ImClone Investigational Site
Los Angeles, California, 90095, United States
ImClone Investigational Site
San Francisco, California, 94115, United States
ImClone Investigational Site
Jacksonville, Florida, 32207, United States
ImClone Investigational Site
Miramar, Florida, 33027, United States
ImClone Investigational Site
Atlanta, Georgia, 30322, United States
ImClone Investigational Site
Honolulu, Hawaii, 96813, United States
ImClone Investigational Site
East Orange, New Jersey, 07018, United States
ImClone Investigational Site
Albuquerque, New Mexico, 87131, United States
ImClone Investigational Site
New York, New York, 10016, United States
ImClone Investigational Site
Chattanooga, Tennessee, 37404, United States
ImClone Investigational Site
Houston, Texas, 77030, United States
ImClone Investigational Site
Seattle, Washington, 98109, United States
ImClone Investigational Site
Buenos Aires, C1019ABS, Argentina
ImClone Investigational Site
Caba, C1050AAK, Argentina
ImClone Investigational Site
Rosario, 2000, Argentina
ImClone Investigational Site
Santa Fe, 3000, Argentina
ImClone Investigational Site
Bankstown, New South Wales, 2200, Australia
ImClone Investigational Site
Kogarah, New South Wales, 2217, Australia
ImClone Investigational Site
Liverpool, New South Wales, 2170, Australia
ImClone Investigational Site
Wollongong, New South Wales, 2500, Australia
ImClone Investigational Site
Southport, Queensland, 4215, Australia
ImClone Investigational Site
Kurralta Park, South Australia, 5037, Australia
ImClone Investigational Site
Coburg, Victoria, 3058, Australia
ImClone Investigational Site
Footscray, Victoria, 3011, Australia
ImClone Investigational Site
Frankston, Victoria, 3199, Australia
ImClone Investigational Site
Parkville, Victoria, 3050, Australia
ImClone Investigational Site
Graz, 8036, Austria
ImClone Investigational Site
Linz, A-4010, Austria
ImClone Investigational Site
Steyr, 4400, Austria
ImClone Investigational Site
Vienna, 1100, Austria
ImClone Investigational Site
Bonheiden, 2820, Belgium
ImClone Investigational Site
Bruges, 8310, Belgium
ImClone Investigational Site
Brussels, 1000, Belgium
ImClone Investigational Site
Brussels, 1070, Belgium
ImClone Investigational Site
Edegem, 2650, Belgium
ImClone Investigational Site
Leuven, 3000, Belgium
ImClone Investigational Site
Belo Horizonte, 30130-100, Brazil
ImClone Investigational Site
Belo Horizonte, 30150-281, Brazil
ImClone Investigational Site
Caxias do Sul, 95070560, Brazil
ImClone Investigational Site
Dois Lajeados, 95900-000, Brazil
ImClone Investigational Site
Gávea, 22451-010, Brazil
ImClone Investigational Site
Ijuí, 98700 000, Brazil
ImClone Investigational Site
Itajaí, 88301-170, Brazil
ImClone Investigational Site
Londrina, 86050-190, Brazil
ImClone Investigational Site
Passo Fundo, 99010-260, Brazil
ImClone Investigational Site
Porto Alegre, 90035-903, Brazil
ImClone Investigational Site
Porto Alegre-Rs, 90020090, Brazil
ImClone Investigational Site
Ribeirão Preto, 14015-130, Brazil
ImClone Investigational Site
Rio de Janeiro, 20231-050, Brazil
ImClone Investigational Site
Salvador, 41820-021, Brazil
ImClone Investigational Site
Sao Jose Rio Preto, 15090-000, Brazil
ImClone Investigational Site
São Paulo, 01246-000, Brazil
ImClone Investigational Site
São Paulo, 04122-000, Brazil
ImClone Investigational Site
São Paulo, Brazil
ImClone Investigational Site
Sorocaba, 18031-000, Brazil
ImClone Investigational Site
Sofia, 1756, Bulgaria
ImClone Investigational Site
Varna, 9000, Bulgaria
ImClone Investigational Site
Providencia, Chile
ImClone Investigational Site
Viña del Mar, Chile
ImClone Investigational Site
Tallinn, 10138, Estonia
ImClone Investigational Site
Tallinn, 13419, Estonia
ImClone Investigational Site
Besançon, 25030, France
ImClone Investigational Site
Brest, 29609, France
ImClone Investigational Site
Clermont-Ferrand, 63003, France
ImClone Investigational Site
Marseille, 13385, France
ImClone Investigational Site
Montbéliard, 25200, France
ImClone Investigational Site
Montpellier, 34298, France
ImClone Investigational Site
Paris, 75013, France
ImClone Investigational Site
Paris, 75015, France
ImClone Investigational Site
Paris, 75475, France
ImClone Investigational Site
Saint-Etienne, 42055, France
ImClone Investigational Site
Berlin, 13353, Germany
ImClone Investigational Site
Bielefeld, 33611, Germany
ImClone Investigational Site
Dresden, 01307, Germany
ImClone Investigational Site
Essen, 45136, Germany
ImClone Investigational Site
Frankfurt, 60596, Germany
ImClone Investigational Site
Hamburg, 22087, Germany
ImClone Investigational Site
Heidelberg, 69115, Germany
ImClone Investigational Site
Leipzig, 04103, Germany
ImClone Investigational Site
Mainz, 55131, Germany
ImClone Investigational Site
Munich, 81737, Germany
ImClone Investigational Site
Recklinghausen, 45657, Germany
ImClone Investigational Site
Tübingen, 72076, Germany
ImClone Investigational Site
Budapest, 1125, Hungary
ImClone Investigational Site
Gyula, 5700, Hungary
ImClone Investigational Site
Kaposvár, 7400, Hungary
ImClone Investigational Site
Pécs, 7624, Hungary
ImClone Investigational Site
Székesfehérvár, 8000, Hungary
ImClone Investigational Site
Beersheba, 84101, Israel
ImClone Investigational Site
Haifa, 31096, Israel
ImClone Investigational Site
Holon, 58100, Israel
ImClone Investigational Site
Jerusalem, 91120, Israel
ImClone Investigational Site
Petah Tikva, 49100, Israel
ImClone Investigational Site
Tel Aviv, 64239, Israel
ImClone Investigational Site
Tel Litwinsky, 52661, Israel
ImClone Investigational Site
Ancona, 60100, Italy
ImClone Investigational Site
Bari, 70126, Italy
ImClone Investigational Site
Bergamo, 24125, Italy
ImClone Investigational Site
Catania, 95122, Italy
ImClone Investigational Site
Genova, 16132, Italy
ImClone Investigational Site
Milan, 20121, Italy
ImClone Investigational Site
Padua, 35128, Italy
ImClone Investigational Site
Pisa, 56126, Italy
ImClone Investigational Site
Torino, 10100, Italy
ImClone Investigational Site
Aichi, 464, Japan
ImClone Investigational Site
Chiba, 277 8577, Japan
ImClone Investigational Site
Ehime, 790-0007, Japan
ImClone Investigational Site
Fukuoka, 811-1395, Japan
ImClone Investigational Site
Hokkaido, 060-0814, Japan
ImClone Investigational Site
Kochi, 781-8555, Japan
ImClone Investigational Site
Osaka, 569-8686, Japan
ImClone Investigational Site
Osaka-Pref, 589, Japan
ImClone Investigational Site
Ōita, 8795593, Japan
ImClone Investigational Site
Saitama, 362-0806, Japan
ImClone Investigational Site
Shizuoka, 411-8777, Japan
ImClone Investigational Site
Tochigi, 320-0834, Japan
ImClone Investigational Site
Tokyo, 181-8611, Japan
ImClone Investigational Site
Kaunas, LT-50009, Lithuania
ImClone Investigational Site
Klaipėda, LT-92288, Lithuania
ImClone Investigational Site
Juchitán, 70000, Mexico
ImClone Investigational Site
Nuevo León, 64060, Mexico
ImClone Investigational Site
Brzozów, 36-200, Poland
ImClone Investigational Site
Bydgoszcz, 85-769, Poland
ImClone Investigational Site
Gdansk, 80-210, Poland
ImClone Investigational Site
Lodz, 93-509, Poland
ImClone Investigational Site
Lublin, 20-090, Poland
ImClone Investigational Site
Poznan, 61- 485, Poland
ImClone Investigational Site
Warsaw, 02-781, Poland
ImClone Investigational Site
Aveiro, 3814-501, Portugal
ImClone Investigational Site
Coimbra, 3001-651, Portugal
ImClone Investigational Site
Evora, 7000-811, Portugal
ImClone Investigational Site
Porto, 4202-451, Portugal
ImClone Investigational Site
Santa Maria da Feira, 4520-211, Portugal
ImClone Investigational Site
Baia Mare, 430031, Romania
ImClone Investigational Site
Bucharest, Romania
ImClone Investigational Site
Iași, 700106, Romania
ImClone Investigational Site
Târgu Mureş, 540072, Romania
ImClone Investigational Site
Krasnodar, 350040, Russia
ImClone Investigational Site
Moscow, 115478, Russia
ImClone Investigational Site
Perm, 614066, Russia
ImClone Investigational Site
Saint Petersburg, 191025, Russia
ImClone Investigational Site
Ufa, 450054, Russia
ImClone Investigational Site
Singapore, 258499, Singapore
ImClone Investigational Site
Incheon, 405-760, South Korea
ImClone Investigational Site
Seongnam-si, 463-707, South Korea
ImClone Investigational Site
Seoul, 110-744, South Korea
ImClone Investigational Site
Suwon, 442-723, South Korea
ImClone Investigational Site
Suwon, 443-721, South Korea
ImClone Investigational Site
Ávila, 05004, Spain
ImClone Investigational Site
Burgos, 9005, Spain
ImClone Investigational Site
Jerez de la Frontera, 11407, Spain
ImClone Investigational Site
Madrid, 28041, Spain
ImClone Investigational Site
Majadahonda, 28222, Spain
ImClone Investigational Site
Palma de Mallorca, 07014, Spain
ImClone Investigational Site
Sabadell, 08208, Spain
ImClone Investigational Site
Seville, 41009, Spain
ImClone Investigational Site
Changhua, 500, Taiwan
ImClone Investigational Site
Kaohsiung City, 833, Taiwan
ImClone Investigational Site
Liouying/Tainan, 736, Taiwan
ImClone Investigational Site
Taichung, 404, Taiwan
ImClone Investigational Site
Tainan, 70403, Taiwan
ImClone Investigational Site
Taipei, 112, Taiwan
ImClone Investigational Site
Maidstone, Kent, ME16 9QQ, United Kingdom
ImClone Investigational Site
Guildford, Surrey, GU2 7XX, United Kingdom
ImClone Investigational Site
Sutton, Surrey, SM2 5PT, United Kingdom
ImClone Investigational Site
Wolverhampton, West Midlands, WV10 0QP, United Kingdom
Related Publications (10)
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.
PMID: 37129153DERIVEDMitani 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.
PMID: 34795131DERIVEDYamaguchi 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.
PMID: 33355909DERIVEDCascinu 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.
PMID: 33274542DERIVEDDe 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.
PMID: 31234645DERIVEDChau 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.
PMID: 30557792DERIVEDTabernero 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.
PMID: 28716815DERIVEDAl-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.
PMID: 26747859DERIVEDShitara 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.
PMID: 26510663DERIVEDWilke 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.
PMID: 25240821DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
One (1) participant was randomized to the placebo/paclitaxel group but received ramucirumab in error. For ITT population this participant was included in placebo/paclitaxel group and for the Safety population included in the ramucirumab group.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2010
First Posted
July 27, 2010
Study Start
December 1, 2010
Primary Completion
July 1, 2013
Study Completion
February 1, 2017
Last Updated
September 18, 2019
Results First Posted
July 31, 2014
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.