ASA404 or Placebo in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Stage IIIb/IV Non-Small Cell Lung Cancer (ATRACT-1)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00662597
First received: April 17, 2008
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to determine if adding ASA404 to standard chemotherapy makes the cancer treatment more effective in patients with advanced lung cancer.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: ASA404
Drug: Placebo
Drug: carboplatin
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 Phase III, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of ASA404 in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Locally Advanced or Metastatic (Stage IIIb/IV) Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall survival rate [ Time Frame: Patients will be followed every six weeks for survival following treatment completion, discontinuation, or documented disease progression until either death or the data cut off date. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival of patients with squamous and non-squamous NSCLC [ Time Frame: Patients will be followed every six weeks for survival following treatment completion, discontinuation, or documented disease progression until either death or the data cut off date. ] [ Designated as safety issue: No ]

Enrollment: 1285
Study Start Date: April 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASA404 Drug: ASA404 Drug: carboplatin Drug: Paclitaxel
Placebo Comparator: ASA40 Placebo Drug: Placebo Drug: carboplatin Drug: Paclitaxel

  Eligibility

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

Inclusion Criteria:

  1. Histologically confirmed non-small cell carcinoma of the lung. (Histological or cytological specimens must be collected via surgical biopsy, brushing, washing or core needle aspiration of a defined lesion. Sputum cytology is not acceptable.)
  2. Newly diagnosed Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease
  3. No prior systemic antineoplastic treatment for Stage IIIb/IV non-small cell carcinoma of the lung (Prior neoadjuvant or adjuvant chemotherapy for earlier stage I/II NSCLC is allowed if 12 months or more prior to Baseline visit.)
  4. Age ≥ 18 years old
  5. WHO Performance Status of 0-1
  6. Measurable or non-measurable disease per RECIST criteria (Post-text supplement 1)
  7. Lab values within the range, as defined below, within 2 weeks of randomization:

    • Absolute neutrophils count (ANC) > 2.0 x 109/L
    • Platelets ≥ 100 x109/L
    • Hemoglobin ≥ 10 g/dL
    • Serum creatinine ≤ 1.5 x ULN (≤ 120 micro mol/L)
    • Serum bilirubin ≤ 1.5 x ULN (≤ 25 micro mol/L)
    • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases)
    • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 x IULN (Sections 6.9.1 and 7.3.4.2)
    • Electrolyte values (potassium, calcium, magnesium) within > 1 x LLN and < 1 x ULN. Patients with corrected electrolyte values are eligible. See Sections 6.8.1 and 7.3.4.3.
    • Females of child-bearing potential must have negative serum pregnancy test (confirmation of negative urine pregnancy test within 72 hours prior to initial dosing).
  8. Life expectancy ≥ 12 weeks
  9. Written informed consent obtained according to local guidelines

Exclusion Criteria:

  1. Patients having CNS metastases (Patients having any clinical signs of CNS metastases must have a CT or MRI of the brain performed to rule out CNS metastases in order to be eligible for study participation. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed.).
  2. Patients with a history of another primary malignancy ≤ 5 years, with the exception of non-melanoma skin cancer or cervical cancer in situ.
  3. Radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities.
  4. Major surgery ≤ 4 weeks prior to randomization or minor surgery ≤ 2 weeks prior to randomization.(Major surgery is defined by the use of general anesthesia however, endoscopic examinations with diagnostic intent are not considered major surgery. Insertion of a vascular access device is exempt from this exclusion criteria. Patients must have recovered from all surgery-related complications.
  5. Concurrent use of other investigational agents and patients who have received investigational agents ≤ 4 weeks prior to randomization
  6. Prior exposure to Tumor-VDAs or other vascular targeting agents (anti-VEGF, anti-VEGF receptor agents, anti-EGFR agents [bevacizumab, cetuximab, etc.])
  7. Pleural effusion that causes ≥ CTC grade 2 dyspnea
  8. Patients with systolic BP > 160 mm Hg and/or diastolic BP >90 mm Hg
  9. Patients with recent hemoptysis associated with NSCLC (> 1 teaspoon in a single episode within 4 weeks)
  10. Patients with any one of the following:

    • Patients with long QT syndrome
    • Patients with a Baseline 12-lead ECG QTc of > 450 msec per central evaluation
    • Congestive heart failure (NY Heart Association class III or IV)
    • Patients with a myocardial infarction within 12 months of study entry
    • Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
    • History of labile hypertension or poor compliance with anti-hypertensive regimen
    • History of a sustained ventricular tachycardia
    • Any history of ventricular fibrillation or Torsades de Pointes
    • Right bundle branch block and left anterior hemiblock (bifasicular block)
    • Bradycardia defined as heart rate < 50 beats per minute
  11. Concomitant use of drugs with a risk of causing Torsades de Pointes (See Table 6-3)
  12. Known allergy or hypersensitivity to platinum-containing drugs, taxanes, other drugs formulated in Cremophor EL (polyoxyethylated castor oil) or any known excipients of these drugs.
  13. Peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
  14. Pregnant or breast feeding females

    • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)

  15. Women of child bearing potential or sexually active males, unwilling or unable to use the required highly effective method(s) of contraception for both sexes while receiving treatment and for at least 6 months after the discontinuation of study treatment. (Adequate forms of contraception include IUD, oral or depot contraceptive or the barrier method plus spermicide.)

    • Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions while taking paclitaxel and therefore are not considered effective contraceptive methods for this study when used as a single agent. Therefore, it is highly recommended that a concomitant barrier method be used with oral, implantable, or injectable contraceptives. The investigator shall counsel the patient accordingly. Women of childbearing potential must have a negative pregnancy test (serum or urine) 72 hours prior to administration of study treatment. For a list of substrates of human liver microsomal P450 enzymes, visit website (http://medicine.iupui.edu/flockhart/)

  16. Concurrent severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, chronic liver disease, confirmed diagnosis of HIV infection or active uncontrolled infection).
  17. Significant neurologic or psychiatric disorder which could compromise participation in the study Patient unwilling or unable to comply with the protocol

Other protocol-defined inclusion/exclusion criteria may apply

  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: NCT00662597

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama/Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
United States, Arizona
Arizona Oncology Associates
Tucson, Arizona, United States, 85704
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724-5024
United States, Arkansas
Highlands Oncology Group
Bentonville, Arkansas, United States, 72712
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
United States, California
Alta Bates Summit Medical Center
Berkeley, California, United States, 94704
Pacific Oncology and Hematology Association
Encinitas, California, United States, 92024
Cancer Care Associates
Fresno, California, United States, 93720
Ronald Yanagihara - Private Practice
Gilroy, California, United States, 95020
California Cancer Care
Greenbrae, California, United States, 94904
Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0698
Loma Linda University Cancer Center
Loma Linda, California, United States, 92354-3834
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
University of California Irvine Comprhensive Center
Orange, California, United States, 92868
Loma Linda Oncology Medical Group, Inc.
Redlands, California, United States, 92374
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
California Pacific Medical Research Institute
San Francisco, California, United States, 94115
Redwood Regional Cancer Center
Santa Rosa, California, United States, 95403
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
Palm Beach Institute of Hematology & Oncology
Boynton Beach, Florida, United States, 33435
Florida Cancer Specialists
Bradenton, Florida, United States, 34209
Cancer Centers of Central Florida, PA
Leesburg, Florida, United States, 34788
Advanced Medical Specialties (ACORN)
Miami, Florida, United States, 33176
United States, Georgia
Northwest Georgia Oncology Centers
Marietta, Georgia, United States, 30060
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Idaho
Kootenai Cancer Center (ACORN)
Couer D'Alene, Idaho, United States, 83814
United States, Illinois
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States, 60657
Illinois Oncology/Warren Billhartz Cancer Ctr.
Maryville, Illinois, United States, 62062
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Hematology/Oncology of North Shore
Skokie, Illinois, United States, 60076
Loyola Cancer Care & Research Ctr. at Central Dupage Hospital
Winfield, Illinois, United States, 60190
United States, Indiana
Ft. Wayne Oncology and Hematology
Ft. Wayne, Indiana, United States, 46815
United States, Iowa
Siouxland Hematology-Oncology Assoc., LLC
Sioux City, Iowa, United States, 51101
United States, Kansas
Kansas City Cancer Center, Southwest
Overland Park, Kansas, United States, 66210
United States, Kentucky
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Louisiana
Hematology Oncology Specialists
Metairie, Louisiana, United States, 70006
Louisiana State University Health Sciences Center - Feist-Weiller Cancer Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
St. Agnes Cancer Center
Baltimore, Maryland, United States, 21129-5299
The Harry and Jeanette Weinberg Cancer Institute at Franklin Square/MedStar Health
Baltimore, Maryland, United States, 21237
Sinai Hospital of Baltimore - The Alvin & Lois Lapidus Cancer Institute
Baltimore, Maryland, United States, 21215-5271
Peninsula Regional Oncology and Hematology
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Boston VA Healthcare System
Boston, Massachusetts, United States, 02130
Fallon Clinic
Worcester, Massachusetts, United States, 01605
United States, Michigan
Breslin Cancer Center
Lansing, Michigan, United States, 48910
Osteopathic Medical Oncology and Hematology PC
Woodhaven, Michigan, United States, 28183
United States, Minnesota
St. Luke's Hospital - St Luke's Cancer Center
Duluth, Minnesota, United States, 55811
United States, Missouri
Kansas City Veterans Affair Medical Center
Kansas City, Missouri, United States, 64128
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
St. Louis Cancer and Breast Institute
St. Louis, Missouri, United States, 63141
Center for Cancer Care and Research (US Oncology)
St. Louis, Missouri, United States, 63141
St. Louis University Cancer Center
St. Louis, Missouri, United States, 63110
United States, Montana
Billings Clinic
Billings, Montana, United States, 59107-7000
Sletten Cancer Institute
Great Falls, Montana, United States, 59405
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, New York
Eastchester Center for Cancer Care
Bronx, New York, United States, 10469
Arena Oncology Associates
Lake Success, New York, United States, 11042
New York Oncology Hematology
Latham, New York, United States, 12210
Hematology Oncology Associates of Rockland
Nyack, New York, United States, 10960
Rochester General Hospital - Lipson Cancer Center
Rochester, New York, United States, 14621
Syracuse VA Medical Center
Syracuse, New York, United States, 13210
United States, North Carolina
Alamance Regional Medical Center-Cancer Ctr.
Burlington, North Carolina, United States, 27215
Carolina Cancer Mgmt/Cape Fear Valley Health System/Med Onc
Fayetteville, North Carolina, United States, 28304
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44309-2090
Oncology Hematology Care Research
Cincinnati, Ohio, United States, 45242
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Medical Oncology Hematology Associates, Inc.
Dayton, Ohio, United States, 45429
Medical Oncology Hematology Associates, Inc. - Dayton Clinical Oncology Program
Dayton, Ohio, United States, 45429
United States, Oklahoma
Cleo Craig Memorial Cancer Ctr. & Research Clinic
Lawton, Oklahoma, United States, 73505
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Kaiser Permanente, Northwest Region
Portland, Oregon, United States, 97227
United States, Pennsylvania
Allegheny General Hospital/Allegheny Cancer Center
Pittsburg, Pennsylvania, United States, 15212
United States, South Carolina
South Carolina Oncology Associate
Columbia, South Carolina, United States, 29210
Lowcountry Hematology & Oncology PA
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37804
The West Clinic
Memphis, Tennessee, United States, 38120
Tennessee Oncology
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology Cancer Center of the High Plains
Amarillo, Texas, United States, 79106
Arlington Cancer Center
Arlington, Texas, United States, 76012
Patient's Comprehensive Cancer Center
Carrolton, Texas, United States, 75010
South Texas Cancer Institute
Corpus Christi, Texas, United States, 78405
Cancer Care Centers of South Texas
Dallas, Texas, United States, 75204
Texas Oncology at Presbyterian Hospital
Dallas, Texas, United States, 75231
University of Texas Southwestern Medical Center/Simmons Comprehensive Cancer Center
Dallas, Texas, United States, 75390-9179
Texas Oncology at Garland
Garland, Texas, United States, 75042
HOPE Oncology
Richardson, Texas, United States, 75080
Tyler Cancer Center
Tyler, Texas, United States, 75702
UT Health Center
Tyler, Texas, United States, 75709
Deke Slayton Cancer Center
Webster, Texas, United States, 77598
Texoma Cancer Center
Wichita Falls, Texas, United States, 76310
United States, Utah
Northern Utah Associates
Ogden, Utah, United States, 84403
United States, Virginia
Danville Hematology & Oncology
Danville, Virginia, United States, 24541
Medical Oncology & Hematology Associates of Northern Virginia
Fairfax, Virginia, United States, 22031
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
United States, Washington
Highline Medical Oncology
Burien, Washington, United States, 98166
Providence Everett Medical Center/Providence regional Cancer Partnership
Everett, Washington, United States, 98201
Northwest Cancer Specialists
Vancouver, Washington, United States, 98684
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Medical Consultants
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin/Division of Neoplastic & Related Disorders
Milwaukee, Wisconsin, United States, 53226
Argentina
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Buenos Aires, Argentina
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Capital Federal, Argentina
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Rosario, Argentina
Australia
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South Brisbane, Australia
Belgium
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Duffel, Belgium
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Jette, Belgium
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Liege, Belgium
Brazil
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Barretos, Brazil
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Belo Horizonte, Brazil
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Goiania, Brazil
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Jaù, Brazil
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Jaú, Brazil
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Porto Alegre, Brazil
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Santo Andre, Brazil
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Sao Paulo, Brazil
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São Paulo, Brazil
Canada
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Calgary, Canada
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Greenfield Park, Canada
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Kitchener, Canada
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London, Canada
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Moncton, Canada
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Montreal, Canada
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Rimouski, Canada
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Sainte-Foy, Canada
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Sherbrooke, Canada
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Sult Ste-Marie, Canada
China
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Bejing, China
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Guangzhou, China
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Wuhan, China
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Xi'an, China
Czech Republic
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Brno, Czech Republic
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Ostrava Poruba, Czech Republic
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Prague, Czech Republic
France
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Bobigny, France
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Boujan-sur-Libron, France
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Clamart Cedex, France
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Le Mans, France
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Limoges, France
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Lyon Cedex, France
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Marseille, France
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Nice, France
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Paris, France
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Saint Herblain, France
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Toulon Armées, France
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Tours Cedex 9, France
Germany
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Aschaffenburg, Germany
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Bad Berka, Germany
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Berlin, Germany
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Donaustauf, Germany
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Ebensberg, Germany
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Essen, Germany
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Freiburg, Germany
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Gerlingen, Germany
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Grosshandsdorf, Germany
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Göttingen, Germany
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Heidenheim, Germany
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Koeln, Germany
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Leipzig, Germany
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Merseburg, Germany
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Muenchen, Germany
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Nuernberg, Germany
Greece
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Athens, Greece
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Heraklion Crete, Greece
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Thessaloniki, Greece
Hong Kong
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Hong Kong, Hong Kong
Hungary
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Budapest, Hungary
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Deszk, Hungary
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Mátraháza, Hungary
Israel
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Kfar-Sava, Israel
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Rehovot, Israel
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Tel-Aviv, Israel
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Tel-Hashomer, Israel
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Zrifin, Israel
Italy
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Avellino, Italy
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Milano, Italy
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Modena, Italy
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Napoli, Italy
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Orbassano, Italy
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Parma, Italy
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Perugia, Italy
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Roma, Italy
Japan
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Akashi, Japan
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Fukuoka, Japan
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Habikino, Japan
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Hiroshima, Japan
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Kashiwa, Japan
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Kobe-city, Japan
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Koto, Japan
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Kumamoto, Japan
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Kurashiki, Japan
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Matsuyama, Japan
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Nagoya, Japan
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Niigata, Japan
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Okayama, Japan
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Osaka, Japan
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Osaka Sayama, Japan
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Sapporo, Japan
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Sendai, Japan
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Ube, Japan
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Yokohama, Japan
Korea, Republic of
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Seoul, Korea, Republic of
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Seungnam, Korea, Republic of
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Suwon, Korea, Republic of
Netherlands
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Amsterdam, Netherlands
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Breda, Netherlands
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Eindhoven, Netherlands
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Harderwijk, Netherlands
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Hertogenbosch, Netherlands
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Zwolle, Netherlands
New Zealand
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Auckland, New Zealand
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Christchurch, New Zealand
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Hamilton, New Zealand
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Wellington, New Zealand
Poland
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Lodz, Poland
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Lublin, Poland
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Otwock, Poland
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Poznan, Poland
Singapore
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Singapore, Singapore
Spain
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Baracaldo, Spain
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Barcelona, Spain
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Córdoba, Spain
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Granada, Spain
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Jaen, Spain
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Madrid, Spain
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Pontevedra, Spain
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Sevilla, Spain
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Zaragoza, Spain
Sweden
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Umea, Sweden
Taiwan
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Kaoshiung, Taiwan
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Lin-Ko, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
Turkey
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Altunizade, Turkey
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Ankara, Turkey
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Istanbul, Turkey
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Izmir, Turkey
United Kingdom
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Aberdeen, United Kingdom
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Cambridge, United Kingdom
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Leicester, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Sutton, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00662597     History of Changes
Other Study ID Numbers: CASA404A2301
Study First Received: April 17, 2008
Last Updated: May 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Tumor vascular disrupting agent
VDA
ASA404
non-small cell lung cancer
NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vadimezan
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014