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A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer (RAINFALL)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02314117
Recruitment Status : Active, not recruiting
First Posted : December 10, 2014
Results First Posted : May 2, 2018
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.

Condition or disease Intervention/treatment Phase
Metastatic Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Drug: Ramucirumab Drug: Capecitabine Drug: Cisplatin Drug: Placebo Drug: Fluorouracil Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 645 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL)
Actual Study Start Date : January 20, 2015
Actual Primary Completion Date : January 17, 2017
Estimated Study Completion Date : July 31, 2019


Arm Intervention/treatment
Experimental: Ramucirumab + Cisplatin + Capecitabine
8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B
  • Cyramza

Drug: Capecitabine
Administered orally

Drug: Cisplatin
Administered IV

Drug: Fluorouracil
Administered IV

Active Comparator: Placebo + Cisplatin + Capecitabine
Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
Drug: Capecitabine
Administered orally

Drug: Cisplatin
Administered IV

Drug: Placebo
Administered IV

Drug: Fluorouracil
Administered IV




Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Randomization to Radiological Disease Progression or Death from Any Cause (Up to 26 Months) ]
    PFS time was measured from the date of randomization to the date of radiographic(rgr) documentation of progression(by RECIST v.1.1) or the date of death due to any cause, whichever was earlier.If a participant did not have a complete baseline tumor assessment,then the PFS time was censored at the randomization date.If a participant was not known to have died or have rgr documented progression as of the data cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. If death or progressive disease(PD) occurred after 2 or more consecutive missing rgr visits,censoring occurred at the date of the last rgr visit prior to the missed visits.If death or PD occurred after postdiscontinuation(pdis) systemic anticancer therapy,censoring occurred at the date of last rgr visit prior to the start of pdis systemic anticancer therapy. PD was defined according to RECIST v.1.1.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Randomization to Death from Any Cause (Up To 30 Months) ]
    OS was time from the date of randomization to the date of death from any cause. If the participant was alive at the cutoff for analysis (or was lost to follow-up), OS data were censored for analysis on the last date the participant was known to be alive.

  2. Progression- Free Survival 2 (PFS2) [ Time Frame: Randomization to Second Radiological or Symptomatic Disease Progression After the Start of Additional Systemic Anticancer Treatment or Death from Any Cause (Up To 26 Months) ]
    PFS2 was defined as the time from the date of randomization to second disease progression (defined as objective radiological or symptomatic progression), or death of any cause, whichever occurs first. Participants alive and for whom a second disease progression has not been observed (including participants who did not receive any additional systemic anticancer treatments) were censored at the last time known to be alive and without second disease progression. The second progression refers to disease progression on or after additional systemic anticancer therapy, regardless if any earlier progression is observed or not(e.g. at the end of study treatment). It is assessed by investigator based on overall clinical evaluation, not limited to RECIST.

  3. Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) [ Time Frame: Randomization to Disease Progression (Up To 26 Months) ]
    Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1).Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).ORR calculated as:(sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.

  4. Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR]) [ Time Frame: Randomization to Disease Progression (Up To 26 Months) ]
    DCR was the percentage of participants with a best overall response of CR, PR, or SD as per Response using RECIST v1.1 criteria. Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).

  5. Time to Progression (TTP) [ Time Frame: Randomization to Disease Progression (Up To 24 Months) ]
    TTP was time from the date of randomization to the date of radiographic progression (according to RECIST v.1.1). If a participant died due to any reason without radiographic progression, TTP is censored at the last adequate tumor assessment. Target lesions: Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions: PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).

  6. Duration of Response (DoR) [ Time Frame: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months) ]
    Participants achieved an objective response if they had a best overall response of CR or PR.Target lesions- CR:Disappearance of all lesions;any pathological lymph nodes must have reduction in short axis to <10 mm.PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum.PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study(the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s).Non target lesions - CR: Disappearance of all lesions and normalization of tumour marker levels;all lymph nodes must be non-pathological in size. Non-CR/Non-PD:Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels.PD:Unequivocal progression of existing lesions or the appearance of new lesion(s).If a participant was not known to have died or have radiographically documented PD as of the data inclusion cutoff date,DOR was censored at the date of the last adequate tumor assessment.

  7. Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale [ Time Frame: Randomization, First worsening in QoL (Up To 26 Months) ]
    Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment.

  8. Change in Health Status on the EuroQol 5-Dimensions 5-Level Instrument (EQ-5D- 5L) [ Time Frame: Randomization, 30 Days After Treatment Discontinuation (Up To 5 Months) ]
    The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.

  9. Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [ Time Frame: Randomization to ECOG PS ≥2 (Up To 26 Months) ]
    The time from the date of randomization to the first date observing ECOG PS ≥2 (that is, deterioration from baseline status of 0 or 1). Participants without PS deterioration were censored at their last documented assessments of 0 or 1. ECOG Performance Status: 2- Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours, 3 -Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 -Completely disabled. Cannot carry on any selfcare.Totally confined to bed or chair,5- Dead.

  10. Number of Participants With Anti-Ramucirumab Antibodies [ Time Frame: Predose Cycle 1 through 30 Days After Treatment Discontinuation (Up To 24 Months) ]
    Participants who developed treatment-emergent antibody responses to Ramucirumab postbaseline.

  11. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab [ Time Frame: Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI ]
    Pharmacokinetics (PK): Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab

  12. PK: Minimum Concentration (Cmin) of Ramucirumab [ Time Frame: Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI ]
    Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a histopathologically confirmed diagnosis of metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. All histologies of nonsquamous cell origin including undifferentiated gastric carcinoma are eligible.
  • Have not received any prior first-line systemic therapy (prior adjuvant or neo-adjuvant therapy is permitted). Participants whose disease has progressed after >12 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
  • Have measurable or nonmeasurable but evaluable disease determined using guidelines in Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1). Baseline tumor assessment should be performed using a high resolution computed tomography (CT) scan using IV and oral contrast unless clinically contra-indicated. Magnetic resonance imaging (MRI) is acceptable if a CT cannot be performed.
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale at baseline.
  • Have adequate organ function.
  • Have baseline clinical and laboratory parameters that are consistent with the requirements prescribed in respective labels and are suitable for consideration of treatment with capecitabine (or 5-FU) and cisplatin (for example, dihydropyrimidine dehydrogenase deficiency).
  • Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator.

Exclusion Criteria:

  • Participants with adenocarcinoma of the esophagus are excluded.
  • Participants with human epidermal growth factor receptor 2 (HER2)-positive status.
  • Participants receiving chronic therapy with nonsteroidal anti-inflammatory agents.
  • Have radiation therapy within 14 days prior to randomization.
  • Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord compression.
  • Have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to randomization.
  • Have experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
  • Have symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
  • Have uncontrolled hypertension prior to initiating study treatment, despite antihypertensive intervention.
  • Have undergone major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to first dose of study treatment, except if the procedure is minimally invasive (for example, introduction of peripherally inserted central catheter [PICC] line) and the investigator does not anticipate any significant bleeding.
  • Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
  • Have a history of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization.
  • Have an acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator.
  • The participant has:

    • cirrhosis at a level of Child-Pugh B (or worse) or
    • cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
  • Have known allergy or hypersensitivity to any components of study treatment.
  • Are pregnant or lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314117


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Locations
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United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
St Jude Medical Center
Fullerton, California, United States, 92835
SMO TRIO -Translational Research
Los Angeles, California, United States, 90024
UCLA Medical Center
Los Angeles, California, United States, 90024
Cancer Care Associates Medical Group
Redondo Beach, California, United States, 90277
Coastal Integrative Cancer Care
San Luis Obispo, California, United States, 93401
Central Coast Medical Oncology Corporation
Santa Monica, California, United States, 93454
United States, Colorado
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8020
United States, Florida
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, United States, 33308
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
Florida Cancer Specialists and Research Institute
Saint Petersburg, Florida, United States, 33705
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Illinois CancerCare
Peoria, Illinois, United States, 61615
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Oncology Hematology Care Inc
Cincinnati, Ohio, United States, 45242
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, United States, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
United States, Texas
UT Southwestern Med Ctr
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
Argentina
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Viedma, Rio Negro, Argentina, 8500
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Rosario, Santa Fe, Argentina, 2000
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Ciudad Autonoma Buenos Aires, Argentina, 1093
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La Rioja, Argentina, 5300
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Rosario, Argentina, S2002KDS
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Salta, Argentina, 4400
Belgium
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Brussels, Belgium, 1200
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Charleroi, Belgium, 6000
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
Canada
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Montreal, Canada, H2L 4M1
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Montreal, Canada, H4A 3J1
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Ottawa, Canada, K1H 8L6
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Toronto, Canada, M4N 3M5
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Toronto, Canada, M5B 1W8
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Toronto, Canada, M5G 1X5
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Toronto, Canada, M5G 2M9
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Vancouver, Canada, V5Z 4E6
Czechia
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Brno, Czechia, 656 53
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Hradec Kralove, Czechia, 500 05
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Olomouc, Czechia, 775 20
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Praha 2, Czechia, 128 08
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Praha 5, Czechia, 150 06
Denmark
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Aalborg, Denmark, 9000
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Aarhus C, Denmark, 8000
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Odense C, Denmark, 5000
Finland
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Helsinki, Finland, 00290 HUS
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Oulu, Finland, 90220
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Turku, Finland, SF-20520
France
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Avignon Cedex 9, France, 84918
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Clermont-Ferrand, France, 63003
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Lille, France, 59037
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Paris, France, 75015
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Saint Etienne, France, 42055
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Saint Herblain Cedex, France, 44805
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Villejuif, France, 94805
Germany
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Dresden, Germany, 01307
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Frankfurt am Main, Germany, 60488
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Hamburg, Germany, 20249
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Mannheim, Germany, 68167
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München, Germany, 81675
Hungary
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Budapest, Hungary, 1097
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Debrecen, Hungary, 4032
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Gyula, Hungary, 5700
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Kaposvar, Hungary, 7400
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Szolnok, Hungary, 5000
Israel
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Haifa, Israel, 3525408
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Jerusalem, Israel, 9112001
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Petach Tikva, Israel, 4941492
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Tel Hashomer, Israel, 5265601
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Tel-Aviv Jaffa, Israel, 6423906
Italy
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Firenze, Italy, 50134
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Milano, Italy, 20133
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Napoli, Italy, 80131
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Padova, Italy, 35128
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Pisa, Italy, 56126
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Roma, Italy, 00168
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Torrette Di Ancona, Italy, 60020
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Udine, Italy, 33100
Japan
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Chiba, Japan, 260-8717
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Fukuoka, Japan, 811-1395
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Higashinari-Ku, Japan, 537-8511
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Kashiwa, Japan, 277 8577
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Kitaadachi-Gun, Japan, 362-0806
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Kobe, Japan, 650-0047
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Koto-ku, Japan, 135-8550
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Nagoya, Japan, 464-8681
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Osaka, Japan, 558-8558
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Suita-shi, Japan, 565-0871
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Sunto-Gun, Japan, 411-8777
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Utsunomiya, Japan, 320-0834
Mexico
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Mexico City, DF, Mexico, 03310
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Guadalajara, Jalisco, Mexico, 44200
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San Bernardino, Toluca, Mexico, 50080
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Juchitan, Mexico, 70000
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Merida, Mexico, 97138
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Mexico City, Mexico, 14080
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Mexico, Mexico, 06760
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Oaxaca, Mexico, 68000
Netherlands
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Amsterdam, Netherlands, 1066 CX
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Amsterdam, Netherlands, 1105 AZ
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Breda, Netherlands, 4819 EV
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Nieuwegein, Netherlands, 3435 CM
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Sittard - Geleen, Netherlands, 6162 BG
Poland
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Gdansk, Poland, 80-219
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Lodz, Poland, 93-513
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Poznan, Poland, 61-485
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Warszawa, Poland, 04-125
Puerto Rico
Ad-Vance Medical Research
Ponce, Puerto Rico, 00717
Hospital Espanol Auxilio Mutuo
San Juan, Puerto Rico, 00918
VA Caribbean Healthcare System
San Juan, Puerto Rico, 00921-3201
Hospital Municipal de San Juan
San Juan, Puerto Rico, 00935
Russian Federation
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Arkhangelsk, Russian Federation, 163045
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Moscow, Russian Federation, 115478
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Saint Petersburg, Russian Federation, 194291
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Saint Petersburg, Russian Federation, 197758
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Saint Petersburg, Russian Federation, 198255
Spain
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Barcelona, Spain, 08003
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Barcelona, Spain, 08035
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Elche, Spain, 03202
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Madrid, Spain, 28007
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Madrid, Spain, 28034
United Kingdom
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Aberdeen, United Kingdom, AB25 2ZN
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Cambridge, United Kingdom, CB2 0QQ
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London, United Kingdom, SE1 9RT
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Manchester, United Kingdom, M20 4BX
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Merseyside, United Kingdom, CH63 4JY
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Nottingham, United Kingdom, NG5 1PB
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Sheffield, United Kingdom, S10 2SJ
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Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02314117     History of Changes
Other Study ID Numbers: 15372
I4T-MC-JVCU ( Other Identifier: Eli Lilly and Company )
2014-002240-40 ( EudraCT Number )
First Posted: December 10, 2014    Key Record Dates
Results First Posted: May 2, 2018
Last Update Posted: February 8, 2019
Last Verified: January 18, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Capecitabine
Fluorouracil
Ramucirumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs