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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other interventions - 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


Other interventions: 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
Other interventions
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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Hawaii
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Caba
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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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Edegem
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Burgos
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Tainan
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Taipei
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Kent
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Surrey
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United Kingdom
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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/ct2/show/NCT01170663
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01170663