Clinical trial NCT00662597: ASA404 or Placebo in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Stage IIIb/IV Non-Small Cell Lung Cancer
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: Tumor vascular disrupting agent
VDA
ASA404
non-small cell lung cancer
NSCLC
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 1285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Overall survival rate
timeFrame: 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.
Secondary outcomes:
measure: Overall survival of patients with squamous and non-squamous NSCLC
timeFrame: 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.
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama/Mitchell Cancer Institute
state: Alabama
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Bentonville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center
state: California
city: Encinitas
country: United States
facility: Pacific Oncology and Hematology Association
state: California
city: Fresno
country: United States
facility: Cancer Care Associates
state: California
city: Gilroy
country: United States
facility: Ronald Yanagihara - Private Practice
state: California
city: Greenbrae
country: United States
facility: California Cancer Care
state: California
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Orange
country: United States
facility: University of California Irvine Comprhensive Center
state: California
city: Redlands
country: United States
facility: Loma Linda Oncology Medical Group, Inc.
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Research Institute
state: California
city: Santa Rosa
country: United States
facility: Redwood Regional Cancer Center
state: California
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Boynton Beach
country: United States
facility: Palm Beach Institute of Hematology & Oncology
state: Florida
city: Bradenton
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Leesburg
country: United States
facility: Cancer Centers of Central Florida, PA
state: Florida
city: Miami
country: United States
facility: Advanced Medical Specialties (ACORN)
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers
state: Georgia
city: Honolulu
country: United States
facility: Cancer Research Center of Hawaii
state: Hawaii
city: Coeur d'Alene
country: United States
facility: Kootenai Cancer Center (ACORN)
state: Idaho
city: Chicago
country: United States
facility: Advocate Illinois Masonic Medical Center
state: Illinois
city: Maryville
country: United States
facility: Illinois Oncology/Warren Billhartz Cancer Ctr.
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Skokie
country: United States
facility: Hematology/Oncology of North Shore
state: Illinois
city: Winfield
country: United States
facility: Loyola Cancer Care & Research Ctr. at Central Dupage Hospital
state: Illinois
city: Fort Wayne
country: United States
facility: Ft. Wayne Oncology and Hematology
state: Indiana
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Assoc., LLC
state: Iowa
city: Overland Park
country: United States
facility: Kansas City Cancer Center, Southwest
state: Kansas
city: Louisville
country: United States
facility: University of Louisville - James Graham Brown Cancer Center
state: Kentucky
city: Metairie
country: United States
facility: Hematology Oncology Specialists
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center - Feist-Weiller Cancer Center
state: Louisiana
city: Baltimore
country: United States
facility: St. Agnes Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore - The Alvin & Lois Lapidus Cancer Institute
state: Maryland
city: Baltimore
country: United States
facility: The Harry and Jeanette Weinberg Cancer Institute at Franklin Square/MedStar Health
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Regional Oncology and Hematology
state: Maryland
city: Boston
country: United States
facility: Boston VA Healthcare System
state: Massachusetts
city: Worcester
country: United States
facility: Fallon Clinic
state: Massachusetts
city: Lansing
country: United States
facility: Breslin Cancer Center
state: Michigan
city: Woodhaven
country: United States
facility: Osteopathic Medical Oncology and Hematology PC
state: Michigan
city: Duluth
country: United States
facility: St. Luke's Hospital - St Luke's Cancer Center
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Veterans Affair Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: Center for Cancer Care and Research (US Oncology)
state: Missouri
city: Saint Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Cancer and Breast Institute
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Great Falls
country: United States
facility: Sletten Cancer Institute
state: Montana
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Bronx
country: United States
facility: Eastchester Center for Cancer Care
state: New York
city: Lake Success
country: United States
facility: Arena Oncology Associates
state: New York
city: Latham
country: United States
facility: New York Oncology Hematology
state: New York
city: Nyack
country: United States
facility: Hematology Oncology Associates of Rockland
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital - Lipson Cancer Center
state: New York
city: Syracuse
country: United States
facility: Syracuse VA Medical Center
state: New York
city: Burlington
country: United States
facility: Alamance Regional Medical Center-Cancer Ctr.
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Cancer Mgmt/Cape Fear Valley Health System/Med Onc
state: North Carolina
city: Akron
country: United States
facility: Akron City Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Dayton
country: United States
facility: Medical Oncology Hematology Associates, Inc. - Dayton Clinical Oncology Program
state: Ohio
city: Dayton
country: United States
facility: Medical Oncology Hematology Associates, Inc.
state: Ohio
city: Lawton
country: United States
facility: Cleo Craig Memorial Cancer Ctr. & Research Clinic
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente, Northwest Region
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny General Hospital/Allegheny Cancer Center
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Oncology Associate
state: South Carolina
city: Mount Pleasant
country: United States
facility: Lowcountry Hematology & Oncology PA
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Associates
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Amarillo
country: United States
facility: Texas Oncology Cancer Center of the High Plains
state: Texas
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Carrollton
country: United States
facility: Patient's Comprehensive Cancer Center
state: Texas
city: Corpus Christi
country: United States
facility: South Texas Cancer Institute
state: Texas
city: Dallas
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology at Presbyterian Hospital
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center/Simmons Comprehensive Cancer Center
state: Texas
city: Garland
country: United States
facility: Texas Oncology at Garland
state: Texas
city: Richardson
country: United States
facility: HOPE Oncology
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Tyler
country: United States
facility: UT Health Center
state: Texas
city: Webster
country: United States
facility: Deke Slayton Cancer Center
state: Texas
city: Wichita Falls
country: United States
facility: Texoma Cancer Center
state: Texas
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
city: Danville
country: United States
facility: Danville Hematology & Oncology
state: Virginia
city: Fairfax
country: United States
facility: Medical Oncology & Hematology Associates of Northern Virginia
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Burien
country: United States
facility: Highline Medical Oncology
state: Washington
city: Everett
country: United States
facility: Providence Everett Medical Center/Providence regional Cancer Partnership
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical Consultants
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/Division of Neoplastic & Related Disorders
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Capital Federal
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: La Plata
country: Argentina
facility: Novartis Investigative Site
city: Mendoza
country: Argentina
facility: Novartis Investigative Site
city: Rosario
country: Argentina
facility: Novartis Investigative Site
city: Heidelberg
country: Australia
facility: Novartis Investigative Site
city: Herston
country: Australia
facility: Novartis Investigative Site
city: South Brisbane
country: Australia
facility: Novartis Investigative Site
city: Duffel
country: Belgium
facility: Novartis Investigative Site
city: Jette
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Barretos
country: Brazil
facility: Novartis Investigative Site
city: Belo Horizonte
country: Brazil
facility: Novartis Investigative Site
city: Goiania
country: Brazil
facility: Novartis Investigative Site
city: Jaù
country: Brazil
facility: Novartis Investigative Site
city: Jaú
country: Brazil
facility: Novartis Investigative Site
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
city: Santo Andre
country: Brazil
facility: Novartis Investigative Site
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
city: Calgary
country: Canada
facility: Novartis Investigative Site
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
city: Kitchener
country: Canada
facility: Novartis Investigative Site
city: London
country: Canada
facility: Novartis Investigative Site
city: Moncton
country: Canada
facility: Novartis Investigative Site
city: Montreal
country: Canada
facility: Novartis Investigative Site
city: Rimouski
country: Canada
facility: Novartis Investigative Site
city: Sainte-Foy
country: Canada
facility: Novartis Investigative Site
city: Sherbrooke
country: Canada
facility: Novartis Investigative Site
city: Sult Ste-Marie
country: Canada
facility: Novartis Investigative Site
city: Bejing
country: China
facility: Novartis Investigative Site
city: Guangzhou
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Wuhan
country: China
facility: Novartis Investigative Site
city: Xi'an
country: China
facility: Novartis Investigative Site
city: Brno
country: Czechia
facility: Novartis Investigative Site
city: Ostrava Poruba
country: Czechia
facility: Novartis Investigative Site
city: Prague
country: Czechia
facility: Novartis Investigative Site
city: Bobigny
country: France
facility: Novartis Investigative Site
city: Boujan-sur-Libron
country: France
facility: Novartis Investigative Site
city: Clamart Cedex
country: France
facility: Novartis Investigative Site
city: Le Mans
country: France
facility: Novartis Investigative Site
city: Limoges
country: France
facility: Novartis Investigative Site
city: Lyon Cedex
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Saint Herblain
country: France
facility: Novartis Investigative Site
city: Toulon Armées
country: France
facility: Novartis Investigative Site
city: Tours Cedex 9
country: France
facility: Novartis Investigative Site
city: Aschaffenburg
country: Germany
facility: Novartis Investigative Site
city: Bad Berka
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Donaustauf
country: Germany
facility: Novartis Investigative Site
city: Ebensberg
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Gerlingen
country: Germany
facility: Novartis Investigative Site
city: Grosshandsdorf
country: Germany
facility: Novartis Investigative Site
city: Göttingen
country: Germany
facility: Novartis Investigative Site
city: Heidenheim
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Merseburg
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Heraklion Crete
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Deszk
country: Hungary
facility: Novartis Investigative Site
city: Mátraháza
country: Hungary
facility: Novartis Investigative Site
city: Kfar-Sava
country: Israel
facility: Novartis Investigative Site
city: Rehovot
country: Israel
facility: Novartis Investigative Site
city: Tel-Aviv
country: Israel
facility: Novartis Investigative Site
city: Tel-Hashomer
country: Israel
facility: Novartis Investigative Site
city: Zrifin
country: Israel
facility: Novartis Investigative Site
city: Avellino
country: Italy
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
city: Modena
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Orbassano
country: Italy
facility: Novartis Investigative Site
city: Parma
country: Italy
facility: Novartis Investigative Site
city: Perugia
country: Italy
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
city: Akashi
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Habikino
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
city: Kobe-city
country: Japan
facility: Novartis Investigative Site
city: Koto
country: Japan
facility: Novartis Investigative Site
city: Kumamoto
country: Japan
facility: Novartis Investigative Site
city: Kurashiki
country: Japan
facility: Novartis Investigative Site
city: Matsuyama
country: Japan
facility: Novartis Investigative Site
city: Nagoya
country: Japan
facility: Novartis Investigative Site
city: Niigata
country: Japan
facility: Novartis Investigative Site
city: Okayama
country: Japan
facility: Novartis Investigative Site
city: Osaka Sayama
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Sapporo
country: Japan
facility: Novartis Investigative Site
city: Sendai
country: Japan
facility: Novartis Investigative Site
city: Ube
country: Japan
facility: Novartis Investigative Site
city: Yokohama
country: Japan
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seungnam
country: Korea, Republic of
facility: Novartis Investigative Site
city: Suwon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Breda
country: Netherlands
facility: Novartis Investigative Site
city: Eindhoven
country: Netherlands
facility: Novartis Investigative Site
city: Harderwijk
country: Netherlands
facility: Novartis Investigative Site
city: Hertogenbosch
country: Netherlands
facility: Novartis Investigative Site
city: Zwolle
country: Netherlands
facility: Novartis Investigative Site
city: Auckland
country: New Zealand
facility: Novartis Investigative Site
city: Christchurch
country: New Zealand
facility: Novartis Investigative Site
city: Hamilton
country: New Zealand
facility: Novartis Investigative Site
city: Wellington
country: New Zealand
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Lublin
country: Poland
facility: Novartis Investigative Site
city: Otwock
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Baracaldo
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Córdoba
country: Spain
facility: Novartis Investigative Site
city: Granada
country: Spain
facility: Novartis Investigative Site
city: Jaen
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Pontevedra
country: Spain
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Umea
country: Sweden
facility: Novartis Investigative Site
city: Kaoshiung
country: Taiwan
facility: Novartis Investigative Site
city: Lin-Ko
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Altunizade
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Aberdeen
country: United Kingdom
facility: Novartis Investigative Site
city: Cambridge
country: United Kingdom
facility: Novartis Investigative Site
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Sutton
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: