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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01170663




Registration number
NCT01170663
Ethics application status
Date submitted
21/07/2010
Date registered
27/07/2010
Date last updated
18/09/2019

Titles & IDs
Public title
A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma
Scientific 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
Secondary ID [1] 0 0
I4T-IE-JVBE
Secondary ID [2] 0 0
13894
Universal Trial Number (UTN)
Trial acronym
RAINBOW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Ramucirumab (IMC-1211B) DP
Treatment: Drugs - Placebo
Treatment: Drugs - Paclitaxel

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

Placebo comparator: Placebo and Paclitaxel - Placebo and Paclitaxel


Treatment: Other: Ramucirumab (IMC-1211B) DP
8 milligrams/kilogram (mg/kg) intravenous (IV) infusion on Days 1 and 15 of every 4-week cycle

Treatment: Drugs: Placebo
Ramucirumab placebo IV infusion on Days 1 and 15 of every 4-week cycle

Treatment: Drugs: Paclitaxel
Paclitaxel 80 milligrams per square meter (mg/m²) IV infusion on Days 1, 8, and 15 of every 4-week cycle
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival Time (OS)
Timepoint [1] 0 0
Randomization up to 27.5 months
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Randomization up to 22.2 months
Secondary outcome [2] 0 0
Time to Progressive Disease (TTP)
Timepoint [2] 0 0
Baseline up to 22.2 months
Secondary outcome [3] 0 0
Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD
Timepoint [3] 0 0
Randomization up to 22.2 months
Secondary outcome [4] 0 0
Percentage of Participants With CR or PR (Objective Response Rate [ORR])
Timepoint [4] 0 0
Randomization up to 22.2 months
Secondary outcome [5] 0 0
Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity)
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion
Timepoint [6] 0 0
Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles)
Secondary outcome [7] 0 0
Cmax After 4th Ramucirumab (IMC-1211B) Infusion
Timepoint [7] 0 0
Cycle 2, Day 15 1 hour post end of infusion (28-day cycles)
Secondary outcome [8] 0 0
Cmax After 7th Ramucirumab (IMC-1211B) Infusion
Timepoint [8] 0 0
Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles)
Secondary outcome [9] 0 0
Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion
Timepoint [9] 0 0
Cycle 1, Day 1 predose (28-day cycles)
Secondary outcome [10] 0 0
Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion
Timepoint [10] 0 0
Cycle 2, Day 15 (28-day cycle)
Secondary outcome [11] 0 0
Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion
Timepoint [11] 0 0
Cycle 4, Day 1 (28-day cycles)
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Baseline, end of therapy (up to 103 weeks)
Secondary outcome [13] 0 0
Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score
Timepoint [13] 0 0
Baseline, end of therapy (up to 103 weeks)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2017
Sample size
Target
Accrual to date
Final
665
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
ImClone Investigational Site - Bankstown
Recruitment hospital [2] 0 0
ImClone Investigational Site - Kogarah
Recruitment hospital [3] 0 0
ImClone Investigational Site - Liverpool
Recruitment hospital [4] 0 0
ImClone Investigational Site - Wollongong
Recruitment hospital [5] 0 0
ImClone Investigational Site - Southport
Recruitment hospital [6] 0 0
ImClone Investigational Site - Kurralta Park
Recruitment hospital [7] 0 0
ImClone Investigational Site - Coburg
Recruitment hospital [8] 0 0
ImClone Investigational Site - Footscray
Recruitment hospital [9] 0 0
ImClone Investigational Site - Frankston
Recruitment hospital [10] 0 0
ImClone Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [7] 0 0
3058 - Coburg
Recruitment postcode(s) [8] 0 0
3011 - Footscray
Recruitment postcode(s) [9] 0 0
3199 - Frankston
Recruitment postcode(s) [10] 0 0
3050 - Parkville
Recruitment outside Australia
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United States of America
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California
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Florida
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Hawaii
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New Jersey
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New Mexico
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New York
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Tennessee
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Texas
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Rosario
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Santa Fe
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Graz
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Linz
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Steyr
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Ufa
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Singapore
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Avila
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Spain
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Burgos
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Kaohsiung
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West Midlands

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

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01170663
Trial related presentations / publications
Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.
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.
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.
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. doi: 10.2217/fon-2019-0243c1.
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01170663