Trial record 1 of 1 for:    20070782
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Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy

This study is currently recruiting participants.
Verified March 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00858364
First received: March 5, 2009
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

This is a double-blind, randomized, placebo-controlled phase 3 non-inferiority study in subjects with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV Non-Small Cell Lung Cancer (NSCLC). Approximately 3000 subjects with stage IV NSCLC expecting to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy will be enrolled into the study. Subjects will be randomized in a 2:1 allocation (Group A: darbepoetin alfa 500 µg every 3 weeks <Q3W>, Group B: placebo Q3W)


Condition Intervention Phase
Non-Small Cell Lung Cancer
Anemia
Cancer
Lung Cancer
Drug: darbepoetin alfa 500 mcg Q3W
Drug: placebo
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: Supportive Care
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: from randomization until death or end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of neutralizing antibody formation to darbepoetin alfa [ Time Frame: first dose of investigative product to the end of treatment period ] [ Designated as safety issue: Yes ]
  • Incidence of at least 1 Red Blood Cell (RBC) transfusion or hemoglobin less than or equal to 8.0 g/dL from study day 1 to end of efficacy treatment period [ Time Frame: study day 1 until end of efficacy treatment period ] [ Designated as safety issue: No ]
  • Incidence of at least 1 Red Blood Cell (RBC) transfusion or hemoglobin less than or equal to 8.0 g/dL from week 5 (day 29) to end of efficacy treatment period [ Time Frame: Study day 29 to end of efficacy treatment period ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) such as thrombovascular events (TVE), venous thromboembolic events (VTE), and AEs associated with Red Blood Cell (RBC) transfusions [ Time Frame: Randomization to 30 days after last dose of darbepoetin alfa ] [ Designated as safety issue: Yes ]
  • Change in hemoglobin from baseline to end of efficacy treatment period [ Time Frame: screening until end of efficacy treatment period ] [ Designated as safety issue: No ]
  • Objective tumor response [ Time Frame: randomization to subjects developing tumor progression ] [ Designated as safety issue: Yes ]
  • Progression-free survival (PFS) [ Time Frame: from randomization until disease progression ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: June 2009
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
darbepoetin alfa 500 µg (Q3W)
Drug: darbepoetin alfa 500 mcg Q3W
darbepoetin alfa 500 mcg (Q3W)
Placebo Comparator: B
Placebo Q3W
Drug: placebo
Placebo

  Eligibility

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

Inclusion Criteria:

  • Subjects with stage IV NSCLC (not recurrent or re-staged).
  • Expected to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy after randomization. Subjects should not be expected to receive only maintenance chemotherapy.
  • Eastern Cooperative Oncology Group performance status of 0 or 1 as assessed within 21 days prior to randomization.
  • 18 years of age or older at screening.
  • Life expectancy greater than 6 months based on the judgment of the investigator and documented during screening.
  • Hemoglobin level less than or equal to 11.0 g/dL as assessed by the local laboratory; sample obtained within 7 days prior to randomization (retest in screening is acceptable).
  • Adequate serum folate (greater than or equal to 2 ng/mL) and vitamin B12 (greater than or equal to 200 pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening.
  • Subjects must have had a baseline scan (CT, MRI, or PET/CT) of the chest to assess disease burden before starting on first line chemotherapy for NSCLC and those images must have been reviewed by the investigator prior to randomization. If the scan was performed more than 28 days prior to randomization, an additional scan must be performed and reviewed by the investigator to confirm that the patient has not progressed before randomization.
  • Before any study-specific procedure, the appropriate written informed consent must be obtained from the subject or a legally accepted representative.

Exclusion Criteria:

  • Known primary benign or malignant hematologic disorder which can cause anemia.
  • History of, or current active cancer other than NSCLC, with the exception of curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in situ, or other primary solid tumors curatively treated with no known active disease present and no curative treatment administered for the last 3 years.
  • Received any prior adjuvant or neoadjuvant therapy for NSCLC.
  • Subjects with a history of brain metastasis.
  • Uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP > 100 mmHg), or as determined by the investigator during screening.
  • History of neutralizing antibody activity to rHuEPO or darbepoetin alfa.
  • Uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia as determined by the investigator at screening. Subjects with known myocardial infarction within 6 months prior to randomization.
  • Subjects with a history of seizure disorder taking anti-seizure medication within 30 days prior to randomization.
  • Clinically significant systemic infection or uncontrolled chronic inflammatory disease (eg, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator during screening.
  • Known seropositivity for HIV or diagnosis of AIDS, positive for hepatitis B surface antigen, or seropositive for hepatitis C virus
  • History of pure red cell aplasia
  • History of deep venous thrombosis or embolic event (eg, pulmonary embolism) within 6 months prior to randomization.
  • Transferrin saturation < 20% and ferritin < 50 ng/mL as assessed by the central laboratory during screening. Subjects must have both to be excluded (supplementation and retest acceptable).
  • Abnormal renal function (serum creatinine level > 2X ULN) as assessed by the central laboratory during screening.
  • Abnormal liver function (total bilirubin > 2X ULN or liver enzymes ALT or AST > 2.5X ULN for subjects without liver metastasis or ≥ 5X ULN for subjects with liver metastasis) as assessed by the central laboratory during screening. Subjects with documented Gilbert's Disease may be eligible.
  • Received any RBC transfusion within 28 days prior to randomization.
  • Plan to receive any RBC transfusion between randomization and study day 1.
  • Known previous treatment failure to ESAs (eg, rHuEPO, darbepoetin alfa).
  • ESA therapy within the 28 days prior to randomization.
  • Known hypersensitivity to recombinant ESAs or the excipients contained within the investigational product.
  • Less than 30 days since receipt of any investigational product or device. Investigational use/receipt of a medicinal product or device that has been approved by the country's local regulatory authority for any indication is permitted.
  • Subjects of reproductive potential who are pregnant, breast feeding or not willing to use effective contraceptive precautions during the study and for at least one month after the last dose of investigational product in the judgment of the investigator (including females of childbearing potential who are partners of male subjects).
  • Previously randomized to this study.
  • Investigator has concerns regarding the ability of the subject to give written informed consent and/or to comply with study procedures (including availability for follow up visits).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858364

Contacts
Contact: Amgen Call Center 866-572-6436

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Locations
United States, Alabama
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Anniston, Alabama, United States, 36207
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Birmingham, Alabama, United States, 35216
United States, Alaska
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Anchorage, Alaska, United States, 99508
United States, Arizona
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Tucson, Arizona, United States, 85704
United States, Arkansas
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Fayetteville, Arkansas, United States, 72703
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Hot Springs, Arkansas, United States, 71913
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Hot Springs, Arkansas, United States, 71913
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Jonesboro, Arkansas, United States, 72401
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Jonesboro, Arkansas, United States, 72401
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Little Rock, Arkansas, United States, 72205
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Berkeley, California, United States, 94704
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Downey, California, United States, 90241
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Fountain Valley, California, United States, 92708
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Fresno, California, United States, 93720
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Fresno, California, United States, 93720
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Fresno, California, United States, 93703
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La Verne, California, United States, 91750
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Lancaster, California, United States, 93534
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Long Beach, California, United States, 90822
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Los Angeles, California, United States, 90024
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Los Angeles, California, United States, 90048
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Los Angeles, California, United States, 90027
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Merced, California, United States, 95348
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Washington, District of Columbia, United States, 20037
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Washington, District of Columbia, United States, 20060
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Boynton Beach, Florida, United States, 33435
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Holiday, Florida, United States, 34691
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Jacksonville, Florida, United States, 32256
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New Port Richey, Florida, United States, 34652
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New Port Richey, Florida, United States, 34655
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New Port Richey, Florida, United States, 34655
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Rockledge, Florida, United States, 32955
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Tamarac, Florida, United States, 33321
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The Villages, Florida, United States, 32159
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Titusville, Florida, United States, 32796
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Dubuque, Iowa, United States, 52001
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Mt Sterling, Kentucky, United States, 40353
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Paducah, Kentucky, United States, 42003
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Paducah, Kentucky, United States, 42001
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Alexandria, Louisiana, United States, 71301
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Alexandria, Louisiana, United States, 71301
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Lafayette, Louisiana, United States, 70503
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New Orleans, Louisiana, United States, 70112
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Shreveport, Louisiana, United States, 71103
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Attleboro, Massachusetts, United States, 02703
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Boston, Massachusetts, United States, 02130
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Boston, Massachusetts, United States, 02135
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Clarkston, Michigan, United States, 48346
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Biloxi, Mississippi, United States, 39531
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Jackson, Mississippi, United States, 39216
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Tupelo, Mississippi, United States, 38801
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Columbia, Missouri, United States, 65201
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Jefferson City, Missouri, United States, 65101
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Kansas City, Missouri, United States, 64132
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Kansas City, Missouri, United States, 64111
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Springfield, Missouri, United States, 65807
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St. Louis, Missouri, United States, 63110
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St. Louis, Missouri, United States, 63136
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Great Falls, Montana, United States, 59405
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Kalispell, Montana, United States, 59901
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Omaha, Nebraska, United States, 68105
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Omaha, Nebraska, United States, 68106
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Henderson, Nevada, United States, 89052
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North Las Vegas, Nevada, United States, 89086
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Manchester, New Hampshire, United States, 03102
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Sparta, New Jersey, United States, 07871
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Teaneck, New Jersey, United States, 07666
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Vineland, New Jersey, United States, 08360
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Albuquerque, New Mexico, United States, 87109-4397
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Sante Fe, New Mexico, United States, 87505
United States, New York
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Albany, New York, United States, 12208
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Brooklyn, New York, United States, 11212
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Buffalo, New York, United States, 14215
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Glens Falls, New York, United States, 12801
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Goshen, New York, United States, 10924
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Lake Success, New York, United States, 11042
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Latham, New York, United States, 12110-0610
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Nyack, New York, United States, 10960
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Staten Island, New York, United States, 10301
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Staten Island, New York, United States, 10310
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Syracuse, New York, United States, 13210
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Valhalla, New York, United States, 10595
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Valhalla, New York, United States, 10595
United States, North Carolina
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Asheboro, North Carolina, United States, 27203
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Asheville, North Carolina, United States, 28801
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Burlington, North Carolina, United States, 27215
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Concord, North Carolina, United States, 28025
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Durham, North Carolina, United States, 27704
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Goldsboro, North Carolina, United States, 27534
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Greenville, North Carolina, United States, 27834
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Hendersonville, North Carolina, United States, 28791
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Hickory, North Carolina, United States, 28602
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High Point, North Carolina, United States, 27262
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Huntersville, North Carolina, United States, 28078
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Kinston, North Carolina, United States, 28501
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Pinehurst, North Carolina, United States, 28374
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Raleigh, North Carolina, United States, 27607
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Washington, North Carolina, United States, 27889
United States, North Dakota
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Bismarck, North Dakota, United States, 58501
United States, Ohio
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Akron, Ohio, United States, 44304
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Columbus, Ohio, United States, 43235
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Massillon, Ohio, United States, 44646
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Middletown, Ohio, United States, 45042
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Port Clinton, Ohio, United States, 43452
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Sylvania, Ohio, United States, 43560
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Wooster, Ohio, United States, 44691
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73102
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Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
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Bethlehem, Pennsylvania, United States, 18015
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Bethlehem, Pennsylvania, United States, 18015
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Gettysburg, Pennsylvania, United States, 17325
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Langhorne, Pennsylvania, United States, 19047
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Philadelphia, Pennsylvania, United States, 19106
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Philadelphia, Pennsylvania, United States, 19140
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Philadelphia, Pennsylvania, United States, 19141
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Philadelphia, Pennsylvania, United States, 19102
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Philadelphia, Pennsylvania, United States, 19107
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Pittsburgh, Pennsylvania, United States, 15240
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Upland, Pennsylvania, United States, 19013
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Willow Grove, Pennsylvania, United States, 19090
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Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
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Pawtucket, Rhode Island, United States, 02860
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Providence, Rhode Island, United States, 02908
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Woonsocket, Rhode Island, United States, 02895
United States, South Carolina
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Aiken, South Carolina, United States, 29801
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Charleston, South Carolina, United States, 29414
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Charleston, South Carolina, United States, 29406
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Columbia, South Carolina, United States, 29210
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Hilton Head Island, South Carolina, United States, 29926
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Myrtle Beach, South Carolina, United States, 29572
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Sumter, South Carolina, United States, 29150
United States, South Dakota
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Aberdeen, South Dakota, United States, 57401
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Sioux Falls, South Dakota, United States, 57105
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Watertown, South Dakota, United States, 57201
United States, Tennessee
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Johnson City, Tennessee, United States, 37604
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Knoxville, Tennessee, United States, 37920
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Memphis, Tennessee, United States, 38104
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Memphis, Tennessee, United States, 38119
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Nashville, Tennessee, United States, 37203
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Abilene, Texas, United States, 79606-5208
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Amarillo, Texas, United States, 79106
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Austin, Texas, United States, 78731
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Beaumont, Texas, United States, 77702
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Bedford, Texas, United States, 76022
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Bryan, Texas, United States, 77802
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Corpus Chisti, Texas, United States, 78405
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Corpus Christi, Texas, United States, 78412
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Dallas, Texas, United States, 75237
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Dallas, Texas, United States, 75230-2510
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Dallas, Texas, United States, 75231
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El Paso, Texas, United States, 79905
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El Paso, Texas, United States, 79915
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Fort Worth, Texas, United States, 76104
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Fredericksburg, Texas, United States, 78624
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Garland, Texas, United States, 75042
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Harlingen, Texas, United States, 78550
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Houston, Texas, United States, 77055
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Houston, Texas, United States, 77090
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Irving, Texas, United States, 75063
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Longview, Texas, United States, 75601
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McAllen, Texas, United States, 78503-1298
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Mesquite, Texas, United States, 75150
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Midland, Texas, United States, 79701-5946
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Paris, Texas, United States, 75460-5004
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Round Rock, Texas, United States, 78665
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San Antonio, Texas, United States, 78217
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San Antonio, Texas, United States, 78229
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Sherman, Texas, United States, 75090-0504
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Southlake, Texas, United States, 76092
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Sugar Land, Texas, United States, 77479
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Tyler, Texas, United States, 75702
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Tyler, Texas, United States, 75701
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Waco, Texas, United States, 76712
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Webster, Texas, United States, 77598
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Wichita Falls, Texas, United States, 76310
United States, Utah
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Ogden, Utah, United States, 84403
United States, Vermont
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White River Junction, Vermont, United States, 05009
United States, Virginia
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Christiansburg, Virginia, United States, 24073
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Fairfax, Virginia, United States, 22031
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Lynchburg, Virginia, United States, 24501
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Newport News, Virginia, United States, 23601
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Portsmouth, Virginia, United States, 23704
United States, Washington
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Bremerton, Washington, United States, 98310
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Burien, Washington, United States, 98166
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Edmonds, Washington, United States, 98026
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Seattle, Washington, United States, 98133
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Spokane, Washington, United States, 99218
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Spokane, Washington, United States, 99202
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Spokane, Washington, United States, 99208
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Tacoma, Washington, United States, 98405
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Vancouver, Washington, United States, 98684
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Yakima, Washington, United States, 98902
United States, Wisconsin
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Green Bay, Wisconsin, United States, 54311
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Janesville, Wisconsin, United States, 53548
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Milwaukee, Wisconsin, United States, 53211
Argentina
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Quilmes, Buenos Aires, Argentina, B1878DVB
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Quilmes, Buenos Aires, Argentina, B1878GEG
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Cordoba, Córdoba, Argentina, X5006HBF
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Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina, C1185AAT
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Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina, C1019ABS
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Rosario, Santa Fe, Argentina, S2002KDS
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Rosario, Santa Fe, Argentina, S2000CVD
Research Site Recruiting
San Miguel de Tucuman, Tucuman, Argentina, T4000GTB
Research Site Completed
Buenos Aires, Argentina, C1180AAX
Research Site Completed
Santa Fe, Argentina, S3000FFU
Austria
Research Site Completed
Steyr, Austria, 4400
Research Site Completed
Wien, Austria, 1090
Belgium
Research Site Recruiting
Ieper, Belgium, 8900
Research Site Recruiting
Libramont, Belgium, 6800
Research Site Recruiting
Liège, Belgium, 4000
Research Site Completed
Namur, Belgium, 5000
Research Site Completed
Ottignies, Belgium, 1340
Brazil
Research Site Recruiting
Salvador, Bahia, Brazil, 40170-110
Research Site Recruiting
Salvador, Bahia, Brazil, 40050-410
Research Site Recruiting
Fortaleza, Ceará, Brazil, 60430-230
Research Site Recruiting
Brasilia, Distrito Federal, Brazil, 72110-150
Research Site Recruiting
Cachoeiro de Itapemirim, Espírito Santo, Brazil, 29308-020
Research Site Recruiting
Campo Grande, Mato Grosso do Sul, Brazil, 79010-050
Research Site Completed
Belo Horizonte, Minas Gerais, Brazil, 30150-281
Research Site Completed
Belo Horizonte, Minas Gerais, Brazil, 30110-090
Research Site Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30285-000
Research Site Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30150-321
Research Site Completed
Curitba, Paraná, Brazil, 59075-740
Research Site Recruiting
Curitiba, Paraná, Brazil, 80010-030
Research Site Completed
Curitiba, Paraná, Brazil, 80530-010
Research Site Recruiting
Londrina, Paraná, Brazil, 86050-190
Research Site Recruiting
Ijui, Rio Grande do Sul, Brazil, 98700-000
Research Site Recruiting
Passo Fundo, Rio Grande do Sul, Brazil, 99010-260
Research Site Recruiting
Pelotas, Rio Grande do Sul, Brazil, 96015-280
Research Site Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90840-440
Research Site Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Research Site Completed
Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
Research Site Recruiting
Itajaí, Santa Catarina, Brazil, 88301-220
Research Site Recruiting
Ribeirao Preto, São Paulo, Brazil, 14015-130
Research Site Completed
Santo Andre, São Paulo, Brazil, 09090-780
Research Site Recruiting
Santo Andre, São Paulo, Brazil, 09060-650
Research Site Completed
Sao Jose dos Campos, São Paulo, Brazil, 12245-750
Research Site Recruiting
Rio de Janeiro, Brazil, 22260-020
Research Site Completed
Rio de Janeiro, Brazil, 22640-000
Research Site Recruiting
São Paulo, Brazil, 01209-000
Research Site Completed
São Paulo, Brazil, 01246-000
Bulgaria
Research Site Recruiting
Plovdiv, Bulgaria, 4004
Research Site Completed
Rousse, Bulgaria, 7002
Research Site Completed
Sofia, Bulgaria, 1784
Research Site Recruiting
Sofia, Bulgaria, 1233
Research Site Completed
Varna, Bulgaria, 9000
Research Site Recruiting
Varna, Bulgaria, 9010
Canada, New Brunswick
Research Site Recruiting
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Research Site Completed
Oshawa, Ontario, Canada, L1G 2B9
Research Site Completed
Toronto, Ontario, Canada, M9N 1N8
Canada, Quebec
Research Site Recruiting
Montreal, Quebec, Canada, H2W 1S6
Research Site Recruiting
Saint-Jerome, Quebec, Canada, J7Z 5T3
Chile
Research Site Recruiting
Temuco, Cautín, Chile, 4810469
Research Site Recruiting
Vina del Mar, Valparaíso, Chile, 2540364
Research Site Recruiting
Santiago, Chile, 7571831
Research Site Completed
Santiago, Chile, 8380455
China, Beijing
Research Site Recruiting
Beijing, Beijing, China, 100142
China, Fujian
Research Site Recruiting
Fuzhou, Fujian, China, 350025
Research Site Recruiting
Fuzhou, Fujian, China, 350005
China, Gansu
Research Site Recruiting
Lanzhou, Gansu, China, 730050
China, Guangdong
Research Site Recruiting
Guangzhou, Guangdong, China, 510060
Research Site Recruiting
Guangzhou, Guangdong, China, 510010
China, Hebei
Research Site Recruiting
Shijiazhuang, Hebei, China, 050011
China, Heilongjiang
Research Site Recruiting
Harbin, Heilongjiang, China, 150040
China, Hunan
Research Site Recruiting
Changsha, Hunan, China, 410013
China, Jiangsu
Research Site Recruiting
Nanjing, Jiangsu, China, 210009
Research Site Recruiting
Nanjing, Jiangsu, China, 210002
Research Site Recruiting
Suzhou, Jiangsu, China, 215004
China, Jiangxi
Research Site Recruiting
Nanchang, Jiangxi, China, 330006
China, Jilin
Research Site Recruiting
Changchun, Jilin, China, 130021
Research Site Recruiting
Changchun, Jilin, China, 130012
China, Liaoning
Research Site Recruiting
Shenyang, Liaoning, China, 110016
China, Shaanxi
Research Site Recruiting
Xi An, Shaanxi, China, 710038
China, Shandong
Research Site Recruiting
Jinan, Shandong, China, 250013
China, Sichuan
Research Site Recruiting
Chengdu, Sichuan, China, 610072
Research Site Recruiting
Chengdu, Sichuan, China, 610041
China, Xinjiang
Research Site Recruiting
Urumqi, Xinjiang, China, 830000
China, Yunnan
Research Site Recruiting
Kunming, Yunnan, China, 650032
China, Zhejiang
Research Site Recruiting
Hangzhou, Zhejiang, China, 310016
China
Research Site Recruiting
Beijing, China, 101149
Research Site Recruiting
Chongqing, China, 400037
Research Site Recruiting
Chongqing, China, 400030
Research Site Recruiting
Shanghai, China, 200032
Research Site Recruiting
Shanghai, China, 200127
Research Site Recruiting
Shanghai, China, 200003
Research Site Recruiting
Shanghai, China, 200092
Croatia
Research Site Completed
Rijeka, Croatia, 51000
Research Site Completed
Zagreb, Croatia, 10000
Czech Republic
Research Site Recruiting
Benesov u Prahy, Czech Republic, 256 30
Research Site Recruiting
Horovice, Czech Republic, 268 31
Research Site Completed
Kutna Hora, Czech Republic, 284 01
Research Site Recruiting
Kyjov, Czech Republic, 697 33
Research Site Completed
Nova Ves pod Plesi, Czech Republic, 262 04
Research Site Recruiting
Ostrava-Poruba, Czech Republic, 708 52
Research Site Completed
Praha 4, Czech Republic, 140 59
Research Site Recruiting
Praha 8, Czech Republic, 180 81
Research Site Completed
Pribram, Czech Republic, 261 01
Germany
Research Site Recruiting
Bad Berka, Germany, 99437
Research Site Recruiting
Bamberg, Germany, 96049
Research Site Recruiting
Grosshansdorf, Germany, 22927
Research Site Recruiting
Halle (Saale), Germany, 06120
Research Site Recruiting
Hemer, Germany, 58675
Research Site Recruiting
Köln, Germany, 50677
Research Site Completed
Köln-Merheim, Germany, 51109
Research Site Completed
Moers, Germany, 47441
Research Site Recruiting
München, Germany, 81737
Research Site Completed
München, Germany, 80336
Research Site Recruiting
München, Germany, 81925
Research Site Completed
Münster, Germany, 48149
Research Site Recruiting
Ulm, Germany, 89081
Greece
Research Site Recruiting
Athens, Greece, 11527
Research Site Recruiting
Chania, Greece, 73300
Research Site Recruiting
Larissa, Greece, 41110
Research Site Recruiting
Nea Kifissia, Athens, Greece, 14564
Research Site Recruiting
Piraeus, Greece, 18537
Research Site Recruiting
Thessaloniki, Greece, 57010
Hong Kong
Research Site Recruiting
Hong Kong, Hong Kong
Research Site Recruiting
Kowloon, Hong Kong
Research Site Recruiting
New Territories, Hong Kong
India
Research Site Recruiting
Hyderabad, Andhra Pradesh, India, 500 034
Research Site Recruiting
Hyderabad, Andhra Pradesh, India, 500 082
Research Site Recruiting
Hyderabad, Andhra Pradesh, India, 500 024
Research Site Recruiting
New Delhi, Delhi, India, 110 030
Research Site Completed
Ahmedabad, Gujarat, India, 380 009
Research Site Completed
Bangalore, Karnataka, India, 560 054
Research Site Completed
Mangalore, Karnataka, India, 575 001
Research Site Completed
Kochi, Kerala, India, 682 304
Research Site Completed
Bhopal, Madhya Pradesh, India, 462 001
Research Site Recruiting
Ahmednagar, Maharashtra, India, 413 736
Research Site Recruiting
Aurangabad, Maharashtra, India, 431 001
Research Site Recruiting
Miraj, Maharashtra, India, 416 410
Research Site Recruiting
Mumbai, Maharashtra, India, 400 012
Research Site Recruiting
Nashik, Maharashtra, India, 422 005
Research Site Recruiting
Nashik, Maharashtra, India, 422 004
Research Site Recruiting
Pune, Maharashtra, India, 411 013
Research Site Recruiting
Pune, Maharashtra, India, 411 001
Research Site Completed
Thane, Maharashtra, India, 400 607
Research Site Recruiting
Jaipur, Rajasthan, India, 302 004
Research Site Recruiting
Jaipur, Rajasthan, India, 302 013
Research Site Recruiting
Chennai, Tamil Nadu, India, 600 100
Research Site Completed
Chennai, Tamil Nadu, India, 600 018
Research Site Recruiting
Madurai, Tamil Nadu, India, 625 107
Research Site Recruiting
Lucknow, Uttar Pradesh, India, 226 003
Research Site Recruiting
Kolkata, West Bengal, India, 700 026
Research Site Recruiting
Kolkata, West Bengal, India, 700 016
Research Site Completed
Bangalore, India, 560 029
Ireland
Research Site Completed
Dublin, Ireland, 24
Research Site Completed
Dublin, Ireland, 8
Israel
Research Site Completed
Jerusalem, Israel, 91120
Research Site Completed
Kfar Saba, Israel, 44281
Research Site Recruiting
Poria Eylit, Israel, 15208
Research Site Completed
Rehovot, Israel, 76100
Research Site Completed
Tel Aviv, Israel, 64239
Italy
Research Site Recruiting
Catania, Italy, 95122
Research Site Completed
Faenza RA, Italy, 48018
Research Site Recruiting
Lecce, Italy, 73100
Research Site Completed
Lugo RA, Italy, 48022
Research Site Completed
Meldola FC, Italy, 47014
Research Site Completed
Messina, Italy, 98125
Research Site Recruiting
Milano, Italy, 20142
Research Site Completed
Napoli, Italy, 80131
Research Site Completed
Ravenna, Italy, 48100
Research Site Completed
San Giovanni Rotondo FG, Italy, 71013
Korea, Republic of
Research Site Recruiting
Daegu, Korea, Republic of, 700-712
Research Site Recruiting
Gwangju, Korea, Republic of, 519-763
Research Site Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Research Site Recruiting
Seoul, Korea, Republic of, 135-710
Research Site Recruiting
Seoul, Korea, Republic of, 136-705
Research Site Recruiting
Seoul, Korea, Republic of, 137-701
Luxembourg
Research Site Recruiting
Differdange, Luxembourg, 4602
Research Site Recruiting
Luxembourg, Luxembourg, 1210
Malaysia
Research Site Recruiting
Kota Bharu, Kelantan, Malaysia, 16150
Research Site Recruiting
Kuantan, Pahang, Malaysia, 25100
Research Site Recruiting
Kota Kinabalu, Sabah, Malaysia, 88996
Research Site Recruiting
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000
Research Site Recruiting
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
Mexico
Research Site Completed
Saltillo, Coahuila, Mexico, 25000
Research Site Recruiting
Mexico, Distrito Federal, Mexico, 06720
Research Site Completed
Mexico, Distrito Federal, Mexico, 07300
Research Site Completed
Mexico City, Distrito Federal, Mexico, 06720
Research Site Recruiting
Mexico City, Distrito Federal, Mexico, 14080
Research Site Completed
Mexico City, Distrito Federal, Mexico, 14140
Research Site Recruiting
Guadalajara, Jalisco, Mexico, 44340
Research Site Completed
Zapopan, Jalisco, Mexico, 45200
Research Site Recruiting
Queretaro, Querétaro, Mexico, 76178
Research Site Completed
Merida, Yucatán, Mexico, 97000
Research Site Recruiting
Colima, Mexico, 28030
Research Site Recruiting
Oaxaca, Mexico, 68000
Research Site Completed
Puebla, Mexico, 72270
Netherlands
Research Site Recruiting
Breda, Netherlands, 4818 CK
Research Site Completed
Eindhoven, Netherlands, 5623 EJ
Research Site Recruiting
Rotterdam, Netherlands, 3015 CE
Philippines
Research Site Recruiting
Davao City, Davao, Philippines, 8000
Research Site Recruiting
Baguio City, Philippines, 2600
Research Site Recruiting
Cebu City, Philippines, 6000
Research Site Recruiting
Makati City, Philippines, 1229
Research Site Recruiting
Manila, Philippines, 1008
Research Site Recruiting
Manila, Philippines, 1000
Research Site Recruiting
Metro Manila, Philippines, 1100
Research Site Recruiting
Pasig City, MetroManila, Philippines, 1604
Research Site Recruiting
Quezon City, Philippines, 1102
Research Site Recruiting
Quezon City, Philippines, 1101
Poland
Research Site Recruiting
Bydgoszcz, Poland, 85-796
Research Site Recruiting
Glucholazy, Poland, 48-340
Research Site Recruiting
Krakow, Poland, 31-202
Research Site Completed
Krakow, Poland, 31-531
Research Site Completed
Lomza, Poland, 18-404
Research Site Completed
Olsztyn, Poland, 10-357
Research Site Completed
Olsztyn, Poland, 10-228
Research Site Completed
Rzeszow, Poland, 35-055
Research Site Recruiting
Suwalki, Poland, 16-400
Research Site Recruiting
Szczecin, Poland, 70-891
Research Site Recruiting
Warszawa, Poland, 02-781
Research Site Recruiting
Wroclaw, Poland, 53-439
Puerto Rico
Research Site Recruiting
San Juan, Puerto Rico, 00927
Research Site Recruiting
San Juan, Puerto Rico, 00910
Romania
Research Site Recruiting
Cluj Napoca, Romania, 400015
Research Site Recruiting
Craiova, Romania, 200385
Research Site Recruiting
Lasi, Romania, 700106
Research Site Completed
Sibiu, Romania, 550245
Research Site Recruiting
Suceava, Romania, 720237
Research Site Recruiting
Timisoara, Romania, 300239
Russian Federation
Research Site Recruiting
Arkhangelsk, Russian Federation, 163045
Research Site Completed
Barnaul, Russian Federation, 656049
Research Site Completed
Belgorod, Russian Federation, 308010
Research Site Recruiting
Ivanovo, Russian Federation, 153013
Research Site Recruiting
Kirov, Russian Federation, 610021
Research Site Completed
Kursk, Russian Federation, 305035
Research Site Completed
Lipetsk, Russian Federation, 398005
Research Site Recruiting
Moscow, Russian Federation, 115478
Research Site Recruiting
Novosibirsk, Russian Federation, 630047
Research Site Recruiting
Obninsk, Russian Federation, 249036
Research Site Completed
Omsk, Russian Federation, 644013
Research Site Recruiting
Orenburg, Russian Federation, 460021
Research Site Recruiting
Penza, Russian Federation, 440071
Research Site Recruiting
Pyatigorsk, Russian Federation, 357502
Research Site Recruiting
Saratov, Russian Federation, 410004
Research Site Recruiting
St Petersburg, Russian Federation, 197089
Research Site Recruiting
Stavropol', Russian Federation, 355047
Research Site Recruiting
Tula, Russian Federation, 300040
Research Site Completed
Tver, Russian Federation, 170008
Research Site Recruiting
Ufa, Russian Federation, 450054
Research Site Completed
Ulyanovsk, Russian Federation, 432063
Research Site Recruiting
Voronezh, Russian Federation, 394000
Research Site Recruiting
Yaroslavl, Russian Federation, 150054
Serbia
Research Site Recruiting
Belgrade, Serbia, 11129
Research Site Recruiting
Gornji Matejevac, Serbia, 18204
Research Site Recruiting
Kragujevac, Serbia, 34000
Research Site Recruiting
Sremska Kamenica, Serbia, 21204
Slovenia
Research Site Recruiting
Golnik, Slovenia, 4204
Research Site Recruiting
Pohorje, Slovenia, 2208
South Africa
Research Site Recruiting
Bloemfontein, South Africa, 9301
Research Site Recruiting
Johannesburg, South Africa, 1501
Research Site Recruiting
Overport, South Africa, 4091
Research Site Recruiting
Polokwane, South Africa, 0699
Spain
Research Site Recruiting
Granada, Andalucía, Spain, 18014
Research Site Recruiting
Las Palmas de Gran Canaria, Canarias, Spain, 35016
Research Site Recruiting
Barcelona, Cataluña, Spain, 08036
Research Site Recruiting
Alicante, Comunidad Valenciana, Spain, 03010
Research Site Completed
Benidorm, Comunidad Valenciana, Spain, 03501
Research Site Recruiting
Valencia, Comunidad Valenciana, Spain, 46017
Research Site Recruiting
Pontevedra, Galicia, Spain, 36002
Switzerland
Research Site Completed
Aarau, Switzerland, 5001
Research Site Completed
Aarau, Switzerland, 5000
Research Site Completed
Chur, Switzerland, 7000
Research Site Completed
Sursee, Switzerland, 6210
Research Site Completed
Zurich, Switzerland, 8063
Taiwan
Research Site Recruiting
Taichung City, Taichung, Taiwan, 40447
Research Site Recruiting
Changhua, Taiwan, 50006
Research Site Recruiting
Kaohsiung, Taiwan, 81362
Research Site Recruiting
Taichung, Taiwan, 40705
Research Site Recruiting
Tainan, Taiwan, 70403
Research Site Recruiting
Tainan, Taiwan, 736
Research Site Recruiting
Tainan, Taiwan, 710
Ukraine
Research Site Recruiting
Chernivtsi, Ukraine, 58013
Research Site Recruiting
Dnipropetrovsk, Ukraine, 49102
Research Site Completed
Kirovograd, Ukraine, 25011
Research Site Recruiting
Kyiv, Ukraine, 04107
Research Site Recruiting
Kyiv, Ukraine, 03115
Research Site Recruiting
Lutsk, Ukraine, 43018
Research Site Recruiting
Lviv, Ukraine, 79031
Research Site Recruiting
Sumy, Ukraine, 40022
Research Site Recruiting
Uzhgorod, Ukraine, 88000
United Kingdom
Research Site Completed
Bebington, United Kingdom, CH63 4JY
Research Site Completed
Dorechester, United Kingdom, DT1 2JY
Research Site Completed
Dorset, United Kingdom, BH15 2JB
Research Site Recruiting
Liverpool, United Kingdom, L14 3PE
Research Site Completed
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00858364     History of Changes
Other Study ID Numbers: 20070782
Study First Received: March 5, 2009
Last Updated: March 26, 2014
Health Authority: Greece: Ministry of Health & Social Solidarity, National Organization for Medicines
Greece: National Ethics Committee
Argentina: Ministry of Health
Austria: Central Ethics Committee
Greece: National Organization for Medicines
Hong Kong: Department of Health
India: Central Drugs Standard Control Organization
Ireland: Irish Medicines Board
Israel: Ministry of Health
Italy: Local Ethics Committees
Italy: Ministry of Health
Italy: The Istituto Superiore di Sanità (ISS) within the Italian National Health Service. Its activities include research, control, training and consultation in the interest of public health protection. Responsible to approved the phase 1 studies.
Luxembourg: Comité National d'Ethique de Recherche
Luxembourg: Direction de la Santé, Division de la Pharmacie et des Médicaments
Mexico: COFEPRIS
Mexico: Ministry of Health
Mexico: SSA (Secretaria de Salud Publica)
Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research
Netherlands: Medicines Evaluation Board
Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider
Phillippines: the Bureau of Food and Drugs
Poland: Drug Institut
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romaina: National Medicines Agency
Romania: Ministry of Health and the Family
Romania: Romanian National Drug Agency
Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health)
Russia: Ministry of Health
Serbia: Medicine and Medical Devices Agency of Serbia
Slovenia: Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (ARSZMP)
Slovenia: National Medical Ethics Committee (Komisija Republike Slovenije Za Medicinsko Etiko)
South Africa: Department of Health
Spain: reference Ethics Committee
Spain: Spanish Agency of Medicines
Spain: Spanish Drug Agency
Switzerland: Agency for Therapeutic Products
Switzerland: Local Ethics Committee
Taiwan: Department of Health
Taiwan: Taiwan Food and Drug Administration
Taiwan: Taiwan Provincial Department of Health
Ukraine: Ministry of Health
Ukraine: Pharmacological Centre at the Ministry of Health of the Ukraine (Pharma Centre)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
United States: Institutional Review Board
Austria: Federal Ministry for Health and Women
Austria: Secretariat of Health
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment
Belgium: Pharmaceutical Inspectorate
Brazil: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ministry of Health
Canada: Health Canada
Canada: Institutional Review Board
Chile: Health Ministry
Croatia: Central Ethics Committee Sredisnje Eticko Povjerenstvo
Croatia: Ministarstvo zdravstva i socijalne skrbi (Ministry of Health and Social Welfare)
Czech Republic: State Institute for Drug Control
EU: CHMP
Germany: Federal Institute for Drugs and Medical Devices
Malaysia: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
South Korea: Institutional Review Board
China: Ethics Committee
China: Food and Drug Administration

Keywords provided by Amgen:
darbepoetin alfa
non-small cell lung cancer
Aranesp
chemotherapy
chemotherapy induce anemia
advanced lung cancer
malignant pleural effusion
metastatic lung cancer
NSCLC
anemia
lung cancer
pleural effusion
Stage IIIB lung cancer
Stage IV lung cancer

Additional relevant MeSH terms:
Anemia
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Hematologic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014