Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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

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
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New Mexico
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Argentina
State/province [11] 0 0
Buenos Aires
Country [12] 0 0
Argentina
State/province [12] 0 0
Caba
Country [13] 0 0
Argentina
State/province [13] 0 0
Rosario
Country [14] 0 0
Argentina
State/province [14] 0 0
Santa Fe
Country [15] 0 0
Austria
State/province [15] 0 0
Graz
Country [16] 0 0
Austria
State/province [16] 0 0
Linz
Country [17] 0 0
Austria
State/province [17] 0 0
Steyr
Country [18] 0 0
Austria
State/province [18] 0 0
Vienna
Country [19] 0 0
Belgium
State/province [19] 0 0
Bonheiden
Country [20] 0 0
Belgium
State/province [20] 0 0
Brugge
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussels
Country [22] 0 0
Belgium
State/province [22] 0 0
Edegem
Country [23] 0 0
Belgium
State/province [23] 0 0
Leuven
Country [24] 0 0
Brazil
State/province [24] 0 0
Belo Horizonte
Country [25] 0 0
Brazil
State/province [25] 0 0
Caxias Do Sul
Country [26] 0 0
Brazil
State/province [26] 0 0
Dois Lajeados
Country [27] 0 0
Brazil
State/province [27] 0 0
Gavea
Country [28] 0 0
Brazil
State/province [28] 0 0
Ijui
Country [29] 0 0
Brazil
State/province [29] 0 0
Itajai
Country [30] 0 0
Brazil
State/province [30] 0 0
Londrina
Country [31] 0 0
Brazil
State/province [31] 0 0
Passo Fundo
Country [32] 0 0
Brazil
State/province [32] 0 0
Porto Alegre-Rs
Country [33] 0 0
Brazil
State/province [33] 0 0
Porto Alegre
Country [34] 0 0
Brazil
State/province [34] 0 0
Ribeirão Preto
Country [35] 0 0
Brazil
State/province [35] 0 0
Rio De Janeiro
Country [36] 0 0
Brazil
State/province [36] 0 0
Salvador
Country [37] 0 0
Brazil
State/province [37] 0 0
Sao Jose Rio Preto
Country [38] 0 0
Brazil
State/province [38] 0 0
Sorocaba
Country [39] 0 0
Brazil
State/province [39] 0 0
São Paulo
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Sofia
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Varna
Country [42] 0 0
Chile
State/province [42] 0 0
Providencia
Country [43] 0 0
Chile
State/province [43] 0 0
Vina Del Mar
Country [44] 0 0
Estonia
State/province [44] 0 0
Tallinn
Country [45] 0 0
France
State/province [45] 0 0
Besancon
Country [46] 0 0
France
State/province [46] 0 0
Brest
Country [47] 0 0
France
State/province [47] 0 0
Clermont-Ferrand
Country [48] 0 0
France
State/province [48] 0 0
Marseille
Country [49] 0 0
France
State/province [49] 0 0
Montbeliard
Country [50] 0 0
France
State/province [50] 0 0
Montpellier
Country [51] 0 0
France
State/province [51] 0 0
Paris
Country [52] 0 0
France
State/province [52] 0 0
Saint-Etienne
Country [53] 0 0
Germany
State/province [53] 0 0
Berlin
Country [54] 0 0
Germany
State/province [54] 0 0
Bielefeld
Country [55] 0 0
Germany
State/province [55] 0 0
Dresden
Country [56] 0 0
Germany
State/province [56] 0 0
Essen
Country [57] 0 0
Germany
State/province [57] 0 0
Frankfurt
Country [58] 0 0
Germany
State/province [58] 0 0
Hamburg
Country [59] 0 0
Germany
State/province [59] 0 0
Heidelberg
Country [60] 0 0
Germany
State/province [60] 0 0
Leipzig
Country [61] 0 0
Germany
State/province [61] 0 0
Mainz
Country [62] 0 0
Germany
State/province [62] 0 0
Munich
Country [63] 0 0
Germany
State/province [63] 0 0
Recklinghausen
Country [64] 0 0
Germany
State/province [64] 0 0
Tuebingen
Country [65] 0 0
Hungary
State/province [65] 0 0
Budapest
Country [66] 0 0
Hungary
State/province [66] 0 0
Gyula
Country [67] 0 0
Hungary
State/province [67] 0 0
Kaposvar
Country [68] 0 0
Hungary
State/province [68] 0 0
Pecs
Country [69] 0 0
Hungary
State/province [69] 0 0
Szekesfehervar
Country [70] 0 0
Israel
State/province [70] 0 0
Beer Sheva
Country [71] 0 0
Israel
State/province [71] 0 0
Haifa
Country [72] 0 0
Israel
State/province [72] 0 0
Holon
Country [73] 0 0
Israel
State/province [73] 0 0
Jerusalem
Country [74] 0 0
Israel
State/province [74] 0 0
Petah Tikva
Country [75] 0 0
Israel
State/province [75] 0 0
Tel Hashomer
Country [76] 0 0
Israel
State/province [76] 0 0
Tel-Aviv
Country [77] 0 0
Italy
State/province [77] 0 0
Ancona
Country [78] 0 0
Italy
State/province [78] 0 0
Bari
Country [79] 0 0
Italy
State/province [79] 0 0
Bergamo
Country [80] 0 0
Italy
State/province [80] 0 0
Catania
Country [81] 0 0
Italy
State/province [81] 0 0
Genova
Country [82] 0 0
Italy
State/province [82] 0 0
Milano
Country [83] 0 0
Italy
State/province [83] 0 0
Padova
Country [84] 0 0
Italy
State/province [84] 0 0
Pisa
Country [85] 0 0
Italy
State/province [85] 0 0
Torino
Country [86] 0 0
Japan
State/province [86] 0 0
Aichi
Country [87] 0 0
Japan
State/province [87] 0 0
Chiba
Country [88] 0 0
Japan
State/province [88] 0 0
Ehime
Country [89] 0 0
Japan
State/province [89] 0 0
Fukuoka
Country [90] 0 0
Japan
State/province [90] 0 0
Hokkaido
Country [91] 0 0
Japan
State/province [91] 0 0
Kochi
Country [92] 0 0
Japan
State/province [92] 0 0
Oita
Country [93] 0 0
Japan
State/province [93] 0 0
Osaka-Pref
Country [94] 0 0
Japan
State/province [94] 0 0
Osaka
Country [95] 0 0
Japan
State/province [95] 0 0
Saitama
Country [96] 0 0
Japan
State/province [96] 0 0
Shizuoka
Country [97] 0 0
Japan
State/province [97] 0 0
Tochigi
Country [98] 0 0
Japan
State/province [98] 0 0
Tokyo
Country [99] 0 0
Korea, Republic of
State/province [99] 0 0
Incheon
Country [100] 0 0
Korea, Republic of
State/province [100] 0 0
Seongnam-Si
Country [101] 0 0
Korea, Republic of
State/province [101] 0 0
Seoul
Country [102] 0 0
Korea, Republic of
State/province [102] 0 0
Suwon-City
Country [103] 0 0
Korea, Republic of
State/province [103] 0 0
Suwon
Country [104] 0 0
Lithuania
State/province [104] 0 0
Kaunas
Country [105] 0 0
Lithuania
State/province [105] 0 0
Klaipeda
Country [106] 0 0
Mexico
State/province [106] 0 0
Juchitan
Country [107] 0 0
Mexico
State/province [107] 0 0
Nuevo Leon
Country [108] 0 0
Poland
State/province [108] 0 0
Brzozow
Country [109] 0 0
Poland
State/province [109] 0 0
Bydgoszcz
Country [110] 0 0
Poland
State/province [110] 0 0
Gdansk
Country [111] 0 0
Poland
State/province [111] 0 0
Lodz
Country [112] 0 0
Poland
State/province [112] 0 0
Lublin
Country [113] 0 0
Poland
State/province [113] 0 0
Poznan
Country [114] 0 0
Poland
State/province [114] 0 0
Warsaw
Country [115] 0 0
Portugal
State/province [115] 0 0
Aveiro
Country [116] 0 0
Portugal
State/province [116] 0 0
Coimbra
Country [117] 0 0
Portugal
State/province [117] 0 0
Evora
Country [118] 0 0
Portugal
State/province [118] 0 0
Porto
Country [119] 0 0
Portugal
State/province [119] 0 0
Santa Maria Da Feira
Country [120] 0 0
Romania
State/province [120] 0 0
Baia Mare
Country [121] 0 0
Romania
State/province [121] 0 0
Bucharest
Country [122] 0 0
Romania
State/province [122] 0 0
Iasi
Country [123] 0 0
Romania
State/province [123] 0 0
Targu Mures
Country [124] 0 0
Russian Federation
State/province [124] 0 0
Krasnodar
Country [125] 0 0
Russian Federation
State/province [125] 0 0
Moscow
Country [126] 0 0
Russian Federation
State/province [126] 0 0
Perm
Country [127] 0 0
Russian Federation
State/province [127] 0 0
Saint Petersburg
Country [128] 0 0
Russian Federation
State/province [128] 0 0
Ufa
Country [129] 0 0
Singapore
State/province [129] 0 0
Singapore
Country [130] 0 0
Spain
State/province [130] 0 0
Avila
Country [131] 0 0
Spain
State/province [131] 0 0
Burgos
Country [132] 0 0
Spain
State/province [132] 0 0
Jerez De La Frontera
Country [133] 0 0
Spain
State/province [133] 0 0
Madrid
Country [134] 0 0
Spain
State/province [134] 0 0
Majadahonda
Country [135] 0 0
Spain
State/province [135] 0 0
Palma De Mallorca
Country [136] 0 0
Spain
State/province [136] 0 0
Sabadell
Country [137] 0 0
Spain
State/province [137] 0 0
Sevilla
Country [138] 0 0
Taiwan
State/province [138] 0 0
Changhua
Country [139] 0 0
Taiwan
State/province [139] 0 0
Kaohsiung
Country [140] 0 0
Taiwan
State/province [140] 0 0
Liouying/Tainan
Country [141] 0 0
Taiwan
State/province [141] 0 0
Taichung
Country [142] 0 0
Taiwan
State/province [142] 0 0
Tainan
Country [143] 0 0
Taiwan
State/province [143] 0 0
Taipei
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Kent
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Surrey
Country [146] 0 0
United Kingdom
State/province [146] 0 0
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01170663