Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00917384
First received: June 8, 2009
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to gather information about the use of an investigational drug called IMC-1121B (Ramucirumab) in adenocarcinomas of the gastroesophageal junction.


Condition Intervention Phase
Gastric Cancer
Adenocarcinoma
Biological: IMC-1121B (ramucirumab)
Drug: Placebo
Other: Best Supportive Care (BSC)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from the date of randomization to the date of death from any cause.


Secondary Outcome Measures:
  • Proportion of Participants Who are Progression-free (PFS) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The 12-week progression-free survival (PFS) rate is defined as the proportion of participants that are alive and progression-free 12 weeks after randomization.

  • Proportion of Participants with Objective Response (Objective Response Rate) [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
    The objective response rate (ORR) is equal to the proportion of participants achieving a best overall response of partial or complete response (PR + CR).

  • Duration of Response [ Time Frame: Approximately 30 Months ] [ Designated as safety issue: No ]
    Duration of response is the interval from date of initial documented response (complete response or partial response) to the first documented date of disease progression or death.

  • Change from Baseline in Quality of Life (QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC-QLQ-C30) Survey [ Time Frame: 18 Weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events [ Time Frame: Approximately 30 Months ] [ Designated as safety issue: Yes ]
  • Maximum concentration (Cmax) of IMC-1121B [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Antibodies against IMC-1121B [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Progression-free Survival (PFS) [ Time Frame: Approximately 30 Months ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever is first.


Enrollment: 355
Study Start Date: August 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMC-1121B (ramucirumab)
Participants receive IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), and best supportive care (BSC) as determined appropriate by the investigator(s). Treatment will continue until there is evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
Biological: IMC-1121B (ramucirumab)
Administered via intravenous infusion every 2 weeks at a dose of 8 mg/kg
Other Names:
  • IMC-1121B
  • LY3009806
Other: Best Supportive Care (BSC)
BSC as determined appropriate by the investigator(s). BSC may include but are not limited to antiemetic agents, opiate and nonopiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.
Placebo Comparator: Placebo
Participants receive injection for intravenous infusion every 2 weeks plus BSC as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel will be blinded as to assignment to active therapy versus placebo, the volume of placebo to be administered will be calculated as if it were active product with a dose of 8 mg/kg. Treatment will continue until there is evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
Drug: Placebo
Placebo comparator for IMC-1121B (ramucirumab) 8 mg/kg as intravenous infusion every 2 weeks
Other: Best Supportive Care (BSC)
BSC as determined appropriate by the investigator(s). BSC may include but are not limited to antiemetic agents, opiate and nonopiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.

Detailed Description:

Placebo-controlled, multicenter Phase 3 study of participants with metastatic gastric cancer [including adenocarcinomas of the gastroesophageal junction (GEJ)] and disease progression on standard first-line chemotherapeutic regimens. Participants will be randomized on a 2:1 basis to receive best supportive care plus IMC-1121B administered every 2 weeks or best supportive care plus placebo administered every 2 weeks, respectively. Participants will undergo radiographic assessment of disease status every 6 weeks. Participant will be treated until there is evidence of progressive disease, toxicity requiring cessation, withdrawal of consent, or until other withdrawal criteria are met.

Approximately 348 participants, with histologically- or cytologically-confirmed, metastatic gastric or GEJ adenocarcinoma, and radiographically measurable disease as defined by the Response Evaluation Criteria in Solid Tumors or evaluable, nonmeasurable disease, will be randomized. Participants will be enrolled from approximately 250 study centers in North America, South America, Central America, Asia, Australia, New Zealand, and Europe.

  Eligibility

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

Inclusion Criteria:

  • Histologically or cytologically confirmed gastric carcinoma, including gastric adenocarcinoma or GEJ adenocarcinoma
  • Metastatic disease or locally recurrent, unresectable disease with measurable lymph node metastases
  • Measurable disease and/or evaluable disease. Measurable disease is defined as at least one unidimensionally-measurable target lesion [≥ 2 centimeter (cm) with conventional techniques or ≥ 1 cm by spiral computed tomography (CT)], as defined by Response using Response Evaluation Criteria in Solid Tumors (RECIST).

Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by RECIST

  • Experienced disease progression during or within 4 months after the last dose of first-line therapy for metastatic disease, or during or within 6 months after the last dose of adjuvant therapy
  • Disease is not amenable to potentially curative resection
  • Participant is ≥ 18 years of age
  • Participant has a life expectancy of ≥ 12 weeks
  • Participant resolution to Grade ≤ 1 (or to Grade ≤ 2 in the case of neuropathy) by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia)
  • Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-1
  • The participant has adequate hepatic function as defined by a total bilirubin ≤ 1.5 milligrams/deciliter (mg/dL) [25.65 micromole/liter (µmol/L)], and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x the upper limit of normal (ULN) [or 5.0 x the ULN in the setting of liver metastases]
  • The participant has adequate renal function as defined by a serum creatinine ≤ 1.5 x the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥ 40 milliliters/minute (mL/min) (that is, if serum creatinine is > 1.5 x the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed)
  • The participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis ([UA]; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine collection for protein must demonstrate < 1000 milligrams (mg) of protein in 24 hours to allow participation in the study)
  • The participant has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥ 1000 microliters (µL), hemoglobin ≥ 9 grams/deciliter (g/dL) [5.58 millimoles/liter (mmol/L)], and platelets ≥ 100,000/µL
  • The participant must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy). Participant on anticoagulation therapy with unresected primary tumors or local tumor recurrence following resection are not eligible
  • If the participant has received prior anthracycline therapy as part of his or her first-line regimen, the participant is able to engage in ordinary physical activity without significant fatigue or dyspnea
  • Because the teratogenicity of IMC-1121B is not known, the participant, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)
  • Female participant of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization
  • Able to provide informed written consent and is amenable to compliance with protocol schedules and testing

Exclusion Criteria:

  • Documented and/or symptomatic brain or leptomeningeal metastases
  • Experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to randomization
  • Experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization
  • Ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator
  • Ongoing or active psychiatric illness or social situation that would limit compliance with study requirements
  • Uncontrolled or poorly-controlled hypertension despite standard medical management
  • Participant has a serious or nonhealing wound, ulcer, or bone fracture
  • Received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer within 2 weeks prior to randomization
  • Received any investigational therapy within 30 days prior to randomization
  • Undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization
  • Received prior therapy with an agent that directly inhibits vascular endothelial growth factor (VEGF) or VEGF receptor 2 (R-2) activity (including bevacizumab), or any antiangiogenic agent
  • Receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use [maximum dose 325 milligram/day (mg/day)] is permitted
  • Participant has elective or planned major surgery to be performed during the course of the clinical trial
  • Participant has a known allergy to any of the treatment components
  • Pregnant or lactating
  • Known to be positive for infection with the human immunodeficiency virus
  • Known alcohol or drug dependency
  • Participant has a concurrent active malignancy other than adequately-treated nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that he/she has been free of disease for > 3 years
  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: NCT00917384

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Locations
United States, California
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Bakersfield, California, United States, 93309
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La Jolla, California, United States, 92093
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Redlands, California, United States, 92374
United States, Illinois
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Chicago, Illinois, United States, 60612
United States, Louisiana
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New Orleans, Louisiana, United States, 70112
United States, Massachusetts
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Boston, Massachusetts, United States, 02115
United States, Nebraska
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Omaha, Nebraska, United States, 68114
United States, New York
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New York, New York, United States, 10003
United States, Pennsylvania
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West Reading, Pennsylvania, United States, 19611
United States, Rhode Island
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Providence, Rhode Island, United States, 02903
United States, South Carolina
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Charleston, South Carolina, United States, 29425
United States, Tennessee
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Knoxville, Tennessee, United States, 37920
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Memphis, Tennessee, United States, 38119
United States, Texas
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Houston, Texas, United States, 77030
Argentina
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Buenos Aires, Argentina, 1425
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Capital Federal, Argentina, 1264
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Ciudad Autonoma de Buenos Aires, Argentina, C1437JCP
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Ciudada Autonoma, Argentina, C1199ABD
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Cordoba, Argentina, 5000
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Rosario, Argentina, S2002KDS
Australia, New South Wales
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Wodonga, New South Wales, Australia, 3690
Australia, Tasmania
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Hobart, Tasmania, Australia, 7000
Australia, Victoria
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East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
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Perth, Western Australia, Australia, 6000
Australia
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Bedford Park, Australia, 5042
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St. Leonards, Australia, NSW 2065
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Woodville, Australia, 5011
Bosnia and Herzegovina
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Sarajevo, Bosnia and Herzegovina, 71000
Brazil
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Barretos, Brazil, 14784-400
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Belo Horizonte, Brazil, 30150-281
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Belo Horizonte, Brazil, 30110-090
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Brasilia, Brazil, 70390-150
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Curitiba, Brazil, 81520-060
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Curitiba, Brazil, 80730-130
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Florianopolis, Brazil, 88034-000
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Ijui, Brazil, 98700-000
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Lajeados, Brazil, 95900-000
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Londrina, Brazil, 86050-190
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Passo Fundo, Brazil, 99010-260
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Porto Alegre, Brazil, 90610-970
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Porto Alegre, Brazil, 90840-440
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Porto Alegre, Brazil, 90035-903
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Sao Paulo, Brazil, 01406-100
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
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Montreal, Quebec, Canada, H2L 4M1
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Sherbrooke, Quebec, Canada, J1G 2E8
Chile
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Concepcion, Chile, 407-0038
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La Serena, Chile
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Santiago, Chile, 6570917
Colombia
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Monteria, Colombia
Croatia
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Osijek, Croatia, 31 100
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Pula, Croatia, 52100
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Slavonski Brod, Croatia, 35 000
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Zagreb, Croatia, 10 000
Czech Republic
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Brno, Czech Republic, 656 53
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Hradec Kralove, Czech Republic, 500 05
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Liberec, Czech Republic, 460 63
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Nova Ves pod Plesi, Czech Republic, 262 04
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Olomouc, Czech Republic, 775 20
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Pardubice, Czech Republic, 532 03
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Prague, Czech Republic, 180 81
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Praha 10, Czech Republic, 100 34
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Praha 2, Czech Republic, 128 08
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Pribram, Czech Republic, 261 95
Egypt
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Alexandria, Egypt, 21131
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Cairo, Egypt, 11796
Guatemala
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Guatemala, Guatemala, 01010
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Guatemala, Guatemala
India
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Hyderabad, Andh Prad, India, 500004
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Hyderabad, Andh Prad, India, 500033
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New Delhi, Delhi, India, 110085
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Bangalore, Karna, India, 560 025
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Bangalore, Karna, India, 560054
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Cochin, Kerala, India, 682304
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Thiruvananthapuram, Kerala, India, 695011
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Trivandrum, Kerala, India, 695011
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Chennai, Kilpauk, India, 600 010
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Bhopal, Madh Prad, India, 462001
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Indore, Madh Prad, India, 452008
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Mumbai, Mahara, India, 400016
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Nashik, Mahara, India, 422 004
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Pune, Mahara, India, 411001
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Chennai, Tamilnadu, India, 600010
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Chennai, Tamilnadu, India, 600035
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Kolkata, W Bengal, India, 700054
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Kolkata, W Bengal, India, 700053
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Bangalore, India, 560 029
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Chennai, India, 600010
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Hyderabad, India, 500 033
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Hyderabad, India, 500004
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Kolkata, India, 700053
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Mumbai, India, 400 012
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Mumbai, India, 400016
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Pune, India, 411001
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West Bengal, India, 700054
Indonesia
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Jakarta, Indonesia, 14450
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Jakarta, Indonesia, 11420
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Jakarta, Indonesia, 10440
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Sumatera Utara, Indonesia, 20136
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West Java, Indonesia, 40161
Italy
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Aviano, Italy, 33081
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Bologna, Italy, 40138
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Brescia, Italy, 25123
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Cremona, Italy, 26100
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Lido di Camaiore, Italy, 55043
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Lucca, Italy, 55043
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Meldola, Italy, 47014
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Mirano, Italy, 30035
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Noale, Italy, 30033
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Potenza, Italy, 85100
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Rimini, Italy, 47900
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Udine, Italy, 33100
Korea, Republic of
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Seoul, Korea, Republic of, 137-701
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Seoul, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 135-720
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Seoul, Korea, Republic of, 136-705
Lebanon
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Beirut, Lebanon
Malta
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Floriana, Malta, FRN 1941
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Floriana, Malta, 1941
Mexico
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Aguascelientes, Mexico, 20217
New Zealand
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Christchurch, New Zealand, 8011
Philippines
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Cebu City, Philippines, 6000
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Pasig City, Philippines, 1604
Poland
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Gdansk, Poland, 80-219
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Krakow, Poland, 31-108
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Olsztyn, Poland, 10-513
Romania
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Baia Mare, Romania, 430031
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Cluj Napoca, Romania, 400015
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Cluj Napoca, Romania, 400058
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Suceava, Romania, 720237
Russian Federation
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Chelyabinsk, Russian Federation, 454087
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Kursk, Russian Federation, 305035
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Moscow, Russian Federation, 125367
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Moscow, Russian Federation, 115478
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Pyatigorsk, Russian Federation, 357524
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St. Petersburg, Russian Federation, 197022
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St. Petersburg, Russian Federation, 197758
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St. Petersburg, Russian Federation, 195067
South Africa
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Cape Town, South Africa, 7925
Spain
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Alcorcon, Spain, 28922
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Barcelona, Spain, 08036
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Barcelona, Spain, 08035
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Elche, Spain, 03203
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Madrid, Spain, 28034
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Santander, Spain, 39008
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Sevilla, Spain, 41021
Taiwan
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Kaohsiung, Taiwan, 807
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Taichung County, Taiwan, 433
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Taipei, Taiwan, 111
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Taipei, Taiwan, 116
Thailand
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Bangkok, Thailand, 10400
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Chiang Mai, Thailand, 50002
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Rajathevee District, Thailand, 10400
Turkey
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Adana, Turkey, 01330
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Gaziantep, Turkey, 27310
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Istanbul, Turkey, 34718
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Izmir, Turkey, 35100
United Kingdom
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Bebington, Wirral, United Kingdom, L83 4JY
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London, United Kingdom, SE1 7EH
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Sutton, United Kingdom, SM2 5PT
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Wolverhampton, 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 by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00917384     History of Changes
Other Study ID Numbers: 13893, 2008-005964-15, CP12-0715, I4T-IE-JVBD
Study First Received: June 8, 2009
Last Updated: May 8, 2014
Health Authority: Argentina: Ministry of Health
Australia: Human Research Ethics Committee
Brazil: National Health Surveillance Agency
Bosnia: Federal Ministry of Health
Canada: Ethics Review Committee
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Ethics Committee
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Egypt: Ministry of Health and Population
Guatemala: Ministry of Public Health and Social Assistance
India: Drugs Controller General of India
Indonesia: National Agency of Drug and Food Control
Italy: Ethics Committee
Italy: Ministry of Health
Korea: Food and Drug Administration
Lebanon: Institutional Review Board
Malaysia: Ministry of Health
Malta: Medicines Authority
Mexico: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Mexico: Federal Commission for Sanitary Risks Protection
New Zealand: Ministry of Health
Philippines: Bureau of Food and Drugs
Poland: Ministry of Health
Romania: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Taiwan: Department of Health
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
IMC-1121B
Monoclonal antibody (MAb)
Vascular endothelial growth factor (VEGF)
Human vascular endothelial growth factor receptor-2 (VEGFR-2)
Platinum resistant
platinum refractory
Gastric
Gastroesophageal Junction Adenocarcinoma
metastatic
Angiogenesis

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Esophageal 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
Head and Neck Neoplasms
Esophageal Diseases
Mitogens
Endothelial Growth Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014