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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
Titles & IDs
Public title
A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma
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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
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Secondary ID [1]
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I4T-IE-JVBE
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Secondary ID [2]
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13894
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Universal Trial Number (UTN)
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Trial acronym
RAINBOW
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival Time (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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Randomization up to 27.5 months
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Secondary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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Randomization up to 22.2 months
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Secondary outcome [2]
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Time to Progressive Disease (TTP)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline up to 22.2 months
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Secondary outcome [3]
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Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD
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Assessment method [3]
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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.
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Timepoint [3]
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Randomization up to 22.2 months
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Secondary outcome [4]
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Percentage of Participants With CR or PR (Objective Response Rate [ORR])
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Assessment method [4]
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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.
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Timepoint [4]
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Randomization up to 22.2 months
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Secondary outcome [5]
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Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity)
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Assessment method [5]
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Participants who developed treatment-emergent antibody responses to Ramucirumab (IMC-1121B) after baseline.
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Timepoint [5]
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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
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Secondary outcome [6]
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Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion
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Assessment method [6]
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Timepoint [6]
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Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles)
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Secondary outcome [7]
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Cmax After 4th Ramucirumab (IMC-1211B) Infusion
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Assessment method [7]
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Timepoint [7]
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Cycle 2, Day 15 1 hour post end of infusion (28-day cycles)
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Secondary outcome [8]
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Cmax After 7th Ramucirumab (IMC-1211B) Infusion
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Assessment method [8]
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Timepoint [8]
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Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles)
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Secondary outcome [9]
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Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion
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Assessment method [9]
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This outcome measure was included in error as the time point was before ramucirumab (IMC-1211B) was administered. Cmin was not analyzed.
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Timepoint [9]
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Cycle 1, Day 1 predose (28-day cycles)
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Secondary outcome [10]
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Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion
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Assessment method [10]
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0
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Timepoint [10]
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Cycle 2, Day 15 (28-day cycle)
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Secondary outcome [11]
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Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion
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Assessment method [11]
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0
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Timepoint [11]
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Cycle 4, Day 1 (28-day cycles)
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Secondary outcome [12]
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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
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline, end of therapy (up to 103 weeks)
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Secondary outcome [13]
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Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline, end of therapy (up to 103 weeks)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2017
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Sample size
Target
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Accrual to date
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Final
665
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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ImClone Investigational Site - Bankstown
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Recruitment hospital [2]
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ImClone Investigational Site - Kogarah
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Recruitment hospital [3]
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ImClone Investigational Site - Liverpool
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Recruitment hospital [4]
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ImClone Investigational Site - Wollongong
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Recruitment hospital [5]
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ImClone Investigational Site - Southport
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Recruitment hospital [6]
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ImClone Investigational Site - Kurralta Park
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Recruitment hospital [7]
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ImClone Investigational Site - Coburg
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Recruitment hospital [8]
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ImClone Investigational Site - Footscray
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Recruitment hospital [9]
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ImClone Investigational Site - Frankston
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Recruitment hospital [10]
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ImClone Investigational Site - Parkville
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Recruitment postcode(s) [1]
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2200 - Bankstown
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment postcode(s) [4]
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2500 - Wollongong
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Recruitment postcode(s) [5]
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4215 - Southport
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Recruitment postcode(s) [6]
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5037 - Kurralta Park
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Recruitment postcode(s) [7]
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3058 - Coburg
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Recruitment postcode(s) [8]
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3011 - Footscray
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Recruitment postcode(s) [9]
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3199 - Frankston
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Recruitment postcode(s) [10]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Florida
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United States of America
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Georgia
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Hawaii
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New Jersey
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New Mexico
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United States of America
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New York
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Rosario
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Argentina
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Santa Fe
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Austria
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Graz
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Austria
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Linz
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Steyr
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Vienna
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Edegem
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Leuven
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Belo Horizonte
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Caxias Do Sul
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Dois Lajeados
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Gavea
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Londrina
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Passo Fundo
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Varna
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Chile
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Providencia
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Estonia
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Tallinn
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Essen
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Germany
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Frankfurt
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Mainz
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Munich
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Recklinghausen
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Germany
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Tuebingen
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Budapest
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Gyula
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Kaposvar
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Hungary
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Pecs
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Hungary
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Israel
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Beer Sheva
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Israel
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Tel Hashomer
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Israel
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Tel-Aviv
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Italy
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Ancona
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Italy
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Bari
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Italy
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Bergamo
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Italy
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Catania
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Italy
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Genova
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Italy
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Milano
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Italy
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Padova
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Italy
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Pisa
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Italy
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Torino
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Suwon
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Coimbra
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Russian Federation
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Perm
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Tainan
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Taipei
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United Kingdom
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Kent
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United Kingdom
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Surrey
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United Kingdom
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West Midlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01170663
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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.
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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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.
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Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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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