A Study of Paclitaxel With or Without Ramucirumab in Metastatic Gastric Adenocarcinoma (RAINBOW)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01170663
First received: July 21, 2010
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

This is a phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab drug product (DP) compared to paclitaxel plus placebo.


Condition Intervention Phase
Gastric Cancer
Biological: Ramucirumab DP
Drug: Placebo
Drug: Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall survival time (OS) [ Time Frame: Approximately 32 months ] [ Designated as safety issue: No ]
    Overall survival time is measured as randomization to date of death from any cause.


Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Approximately 32 months ] [ Designated as safety issue: No ]
    PFS is measured from randomization to the first radiographically documented progressive disease (PD) or death.

  • Time to progressive disease (TTP) [ Time Frame: Approximately 32 months ] [ Designated as safety issue: No ]
    TTP is the time from randomization to the first radiographically documented progressive disease.

  • Best overall response (BOR) [ Time Frame: Approximately 32 months ] [ Designated as safety issue: No ]
    Number of participants whose best response is categorized as determined using the Response Evaluation Criteria In Solid Tumors (RECIST) (ver 1.1) guidelines.

  • Objective response (ORR) [ Time Frame: Approximately 32 months ] [ Designated as safety issue: No ]
    Proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR) compared to the total number of participants. Best response is categorized using the Response Evaluation Criteria In Solid Tumors (RECIST) (ver 1.1) guidelines.

  • Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity) [ Time Frame: 32 months ] [ Designated as safety issue: No ]
    This assessment will only be done at specific time points i.e. Prior to (within Pretreatment period) and after first ramucirumab infusion, prior to and after fourth ramucirumab infusion (approx. week 6 after first dose), prior to and after seventh ramucirumab infusion (approx. week 12 after first dose) and 30-37 days after last dose of study therapy.

  • Maximum concentration (Cmax) after first ramucirumab infusion [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Maximum concentration (Cmax) is the maximum peak concentration measured in blood serum after first ramucirumab infusion.

  • Maximum concentration (Cmax) after 4th ramucirumab infusion [ Time Frame: Approximately week 6 (Cycle 2, Day 15) ] [ Designated as safety issue: No ]
    Maximum concentration (Cmax) is the maximum peak concentration measured in blood serum after 4th ramucirumab infusion.

  • Maximum concentration (Cmax) after 7th ramucirumab infusion [ Time Frame: Approximately week 12 (Cycle 4, Day 1) ] [ Designated as safety issue: No ]
    Maximum concentration (Cmax) is the maximum peak concentration measured in blood serum after 7th ramucirumab infusion.

  • Minimum concentration (Cmin) prior to first ramucirumab infusion [ Time Frame: within the pretreatment period until Day 1 ] [ Designated as safety issue: No ]
    Minimum concentration (Cmin) is the minimum trough concentration measured in blood serum prior to first ramucirumab infusion.

  • Minimum concentration (Cmin) prior to 4th ramucirumab infusion [ Time Frame: Approximately week 6 (Cycle 2, Day 15) ] [ Designated as safety issue: No ]
    Minimum concentration (Cmin) is the minimum trough concentration measured in blood serum prior to 4th ramucirumab infusion.

  • Minimum concentration (Cmin) prior to 7th ramucirumab infusion [ Time Frame: Approximately week 12 (Cycle 4, Day 1) ] [ Designated as safety issue: No ]
    Minimum concentration (Cmin) is the minimum trough concentration measured in blood serum prior to 7th ramucirumab infusion.

  • Change in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 [ Time Frame: 32 months ] [ Designated as safety issue: No ]
    Change from baseline in the patient reported outcomes measured at the end of therapy visit

  • Change in EuroQol EQ-5D [ Time Frame: 32 months ] [ Designated as safety issue: No ]
    Change from baseline to the end of therapy visit


Enrollment: 665
Study Start Date: December 2010
Estimated Study Completion Date: September 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramucirumab DP and Paclitaxel
Ramucirumab DP and Paclitaxel
Biological: Ramucirumab DP
8 mg/kg I.V. infusion on Days 1 and 15 of every 4-week cycle
Other Names:
  • LY3009806
  • IMC-1211B
Drug: Paclitaxel
Paclitaxel 80 mg/m2 I.V. infusion on Days 1, 8, and 15 of every 4-week cycle
Placebo Comparator: Placebo and Paclitaxel
Placebo and Paclitaxel
Drug: Placebo
Ramucirumab placebo I.V. infusion on Days 1 and 15 of every 4-week cycle
Drug: Paclitaxel
Paclitaxel 80 mg/m2 I.V. infusion on Days 1, 8, and 15 of every 4-week cycle

Detailed Description:

The aim of this study is to determine if paclitaxel given together with ramucirumab as second line therapy will prolong overall survival compared to paclitaxel alone.

Approximately 663 patients (at least 18 years) in approximately 200 study centers and in approximately 30 countries will be randomized with histologically or cytologically confirmed metastatic gastric or gastroesophageal junction adenocarcinoma. Patients must have received at least one cycle of first line therapy with any platinum/fluoropyrimidine doublet with or without anthracycline (epirubicin or doxorubicin) and must have discontinued this therapy prior to study entry due to disease progression.

Upon registration and completion of screening procedure and reviewing the Inclusion and Exclusion Criteria eligible patients will be randomized to receive either paclitaxel plus ramucirumab or paclitaxel plus placebo.

Ramucirumab DP/placebo will be administered i.v. on days 1 and 15 , paclitaxel will be administered i.v. on days 1, 8 and 15 of a 4 weekly cycle.

Patients will be continuously treated and monitored until radiographic or symptomatic progression of disease, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (ECOG 0 to 1)

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 CNS metastasis at baseline
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170663

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Locations
United States, California
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Burbank, California, United States, 91505
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Los Angeles, California, United States, 90095
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San Francisco, California, United States, 94115
United States, Florida
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Jacksonville, Florida, United States, 32207
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Miramar, Florida, United States, 33027
United States, Georgia
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Atlanta, Georgia, United States, 30322
United States, Hawaii
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Honolulu, Hawaii, United States, 96813
United States, New Jersey
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East Orange, New Jersey, United States, 07018
United States, New Mexico
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Albuquerque, New Mexico, United States, 87131
United States, New York
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New York, New York, United States, 10016
United States, Tennessee
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Chattanooga, Tennessee, United States, 37404
United States, Texas
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Houston, Texas, United States, 77030
United States, Washington
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Seattle, Washington, United States, 98109
Argentina
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Buenos Aires, Argentina, C1019ABS
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Caba, Argentina, C1050AAK
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Rosario, Argentina, 2000
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Santa Fe, Argentina, 3000
Australia, New South Wales
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Bankstown, New South Wales, Australia, 2200
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Kogarah, New South Wales, Australia, 2217
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Liverpool, New South Wales, Australia, 2170
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Wollongong, New South Wales, Australia, 2500
Australia, Queensland
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Southport, Queensland, Australia, 4215
Australia, South Australia
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Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
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Coburg, Victoria, Australia, 3058
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Footscray, Victoria, Australia, 3011
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Frankston, Victoria, Australia, 3199
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Parkville, Victoria, Australia, 3050
Austria
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Graz, Austria, 8036
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Linz, Austria, A-4010
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Steyr, Austria, 4400
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Vienna, Austria, 1100
Belgium
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Bonheiden, Belgium, 2820
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Brugge, Belgium, 8310
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Brussels, Belgium, 1070
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Brussels, Belgium, 1000
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Edegem, Belgium, 2650
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Leuven, Belgium, 3000
Brazil
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Belo Horizonte, Brazil, 30130-100
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Belo Horizonte, Brazil, 30150-281
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Caxias Do Sul, Brazil, 95070560
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Dois Lajeados, Brazil, 95900-000
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Gavea, Brazil, 22451-010
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Ijui, Brazil, 98700 000
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Itajai, Brazil, 88301-170
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Londrina, Brazil, 86050-190
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Passo Fundo, Brazil, 99010-260
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Porto Alegre, Brazil, 90035-903
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Porto Alegre-Rs, Brazil, 90020090
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Ribeirão Preto, Brazil, 14015-130
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Rio De Janeiro, Brazil, 20231-050
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Salvador, Brazil, 41820-021
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Sao Jose Rio Preto, Brazil, 15090-000
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Sorocaba, Brazil, 18031-000
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São Paulo, Brazil, 04122-000
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São Paulo, Brazil, 01246-000
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São Paulo, Brazil
Bulgaria
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Sofia, Bulgaria, 1756
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Varna, Bulgaria, 9000
Chile
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Providencia, Chile
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Vina Del Mar, Chile
Estonia
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Tallinn, Estonia, 10138
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Tallinn, Estonia, 13419
France
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Besancon, France, 25030
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Brest, France, 29609
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Clermont-Ferrand, France, 63003
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Marseille, France, 13385
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Montbeliard, France, 25200
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Montpellier, France, 34298
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Paris, France, 75475
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Paris, France, 75013
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Paris, France, 75015
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Saint-Etienne, France, 42055
Germany
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Berlin, Germany, 13353
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Bielefeld, Germany, 33611
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Dresden, Germany, 01307
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Essen, Germany, 45136
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Frankfurt, Germany, 60596
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Hamburg, Germany, 22087
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Heidelberg, Germany, 69115
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Leipzig, Germany, 04103
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Mainz, Germany, 55131
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Munich, Germany, 81737
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Recklinghausen, Germany, 45657
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Tuebingen, Germany, 72076
Hungary
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Budapest, Hungary, 1125
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Gyula, Hungary, 5700
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Kaposvar, Hungary, 7400
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Pecs, Hungary, 7624
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Szekesfehervar, Hungary, 8000
Israel
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Beer Sheva, Israel, 84101
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Haifa, Israel, 31096
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Holon, Israel, 58100
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Jerusalem, Israel, 91120
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Petah Tikva, Israel, 49100
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Tel Hashomer, Israel, 52661
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Tel-Aviv, Israel, 64239
Italy
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Ancona, Italy, 60100
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Bari, Italy, 70126
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Bergamo, Italy, 24125
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Catania, Italy, 95122
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Genova, Italy, 16132
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Milano, Italy, 20121
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Padova, Italy, 35128
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Pisa, Italy, 56126
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Torino, Italy, 10100
Japan
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Aichi, Japan, 464
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Chiba, Japan, 277 8577
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Ehime, Japan, 790-0007
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Fukuoka, Japan, 811-1395
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Hokkaido, Japan, 060-0814
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Kochi, Japan, 781-8555
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Oita, Japan, 8795593
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Osaka, Japan, 569-8686
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Osaka-Pref, Japan, 589
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Saitama, Japan, 362-0806
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Shizuoka, Japan, 411-8777
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Tochigi, Japan, 320-0834
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Tokyo, Japan, 181-8611
Korea, Republic of
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Incheon, Korea, Republic of, 405-760
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Seongnam-Si, Korea, Republic of, 463-707
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Seoul, Korea, Republic of, 110-744
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Suwon, Korea, Republic of, 443-721
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Suwon-City, Korea, Republic of, 442-723
Lithuania
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Kaunas, Lithuania, LT-50009
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Klaipeda, Lithuania, LT-92288
Mexico
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Juchitan, Mexico, 70000
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Nuevo Leon, Mexico, 64060
Poland
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Brzozow, Poland, 36-200
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Bydgoszcz, Poland, 85-769
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Gdansk, Poland, 80-210
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Lodz, Poland, 93-509
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Lublin, Poland, 20-090
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Poznan, Poland, 61- 485
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Warsaw, Poland, 02-781
Portugal
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Aveiro, Portugal, 3814-501
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Coimbra, Portugal, 3001-651
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Evora, Portugal, 7000-811
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Porto, Portugal, 4202-451
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Santa Maria Da Feira, Portugal, 4520-211
Romania
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Baia Mare, Romania, 430031
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Bucharest, Romania
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Iasi, Romania, 700106
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Targu Mures, Romania, 540072
Russian Federation
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Krasnodar, Russian Federation, 350040
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Moscow, Russian Federation, 115478
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Perm, Russian Federation, 614066
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Saint Petersburg, Russian Federation, 191025
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Ufa, Russian Federation, 450054
Singapore
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Singapore, Singapore, 258499
Spain
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Avila, Spain, 05004
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Burgos, Spain, 9005
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Jerez De La Frontera, Spain, 11407
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Madrid, Spain, 28041
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Majadahonda, Spain, 28222
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Palma De Mallorca, Spain, 07014
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Sabadell, Spain, 08208
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Sevilla, Spain, 41009
Taiwan
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Changhua, Taiwan, 500
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Kaohsiung, Taiwan, 833
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Liouying/Tainan, Taiwan, 736
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Taichung, Taiwan, 404
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Tainan, Taiwan, 70403
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Taipei, Taiwan, 112
United Kingdom
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Maidstone, Kent, United Kingdom, ME16 9QQ
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Guildford, Surrey, United Kingdom, GU2 7XX
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Sutton, Surrey, United Kingdom, SM2 5PT
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Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01170663     History of Changes
Other Study ID Numbers: 13894, I4T-IE-JVBE, CP12-0922, 2010-020426-18
Study First Received: July 21, 2010
Last Updated: August 14, 2013
Health Authority: Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Ministry of Health
Chile: Ministry of Health
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Ministry of Health
Poland: Ministry of Health
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Taiwan: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Metastatic Adenocarcinoma
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014