EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

Neoplasms, Breast Clinical Trial

Official title:

An Open-Label Expanded Access Study of Lapatinib and Capecitabine Therapy in Subjects With ErbB2 Overexpressing Locally Advanced or Metastatic Breast Cancer

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT00338247
• Other study ID #: EGF103659
• Status: Approved for marketing
• Phase: Phase 4
• First received: June 16, 2006
• Last updated: April 4, 2016
• Start date: July 2006
• Est. completion date: March 2015

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationUnited States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial Summary

This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• May have received prior lapatinib in another trial. Previous capecitabine (as previous agent or non-lapatinib containing regimen) is also permitted.

• Prior treatment with hormonal therapy is allowed.

• Must have advanced or metastatic breast cancer with progression (as assessed by modified RECIST) after prior therapy, which must include all of the following: prior treatment with an anthracycline, a taxane, and trastuzumab alone or in combination with other therapy. Trastuzumab must have been administered in the adjuvant, or locally advanced or metastatic setting.

• Must have tumors that overexpress ErbB2 defined as +3 by IHC or FISH positive for ErbB2 gene amplification. The status of ErbB2 expression must be documented prior to study entry.

• Must be >/= 18 years of age

• Life expectancy of > 8 weeks

• Must have recovered from side effects of previous treatment

• Patients with CNS mets are eligible provided treatment with prohibited medications as listed in the protocol are not required

• Cardiac ejection fraction must be within the institutional range of normal as measured by ECHO. MUGA scans are allowed if ECHOs cannot be performed

• Able to swallow and retain oral medications

• Must have adequate hematologic, hepatic and renal function

Exclusion criteria:

• Pregnant or lactating females

• Malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or bowel, or ulcerative colitis

• Concurrent disease or condition that would make the patient inappropriate for study participation

• Unresolved or unstable toxicity from prior administration of another investigational drug and/or prior cancer treatment

• Uncontrolled infection

• Active cardiac disease defined as history of uncontrolled or symptomatic angina; history of arrhythmias requiring medication, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation; MI < 6 months from study entry; uncontrolled or symptomatic CHF; ejection fraction below the institutional normal limit; any other cardiac condition that would make this protocol unreasonably hazardous for the patient

• Receiving concurrent chemotherapy (other than capecitabine), radiation therapy, immunotherapy, biologic therapy or hormonal therapy for cancer. Concurrent therapy with bisphosphonates is allowed

• History of allergic reaction attributed to compounds of similar composition to lapatinib or any excipients

• History of allergic reactions attributed to compounds of similar chemical composition to capecitabine, fluorouracil or excipients

• Known DPD deficiency

Study Design

N/A

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasms, Breast

Intervention

Drug:
• lapatinib + capecitabine
Experimental

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Bedford Park	South Australia
Australia	Novartis Investigative Site	Box Hill	Victoria
Australia	Novartis Investigative Site	Fitzroy	Victoria
Australia	Novartis Investigative Site	Geelong	Victoria
Australia	Novartis Investigative Site	Herston	Queensland
Australia	Novartis Investigative Site	Hobart	Tasmania
Australia	Novartis Investigative Site	Kogarah	New South Wales
Australia	Novartis Investigative Site	Nedlands	Western Australia
Australia	Novartis Investigative Site	North Sydney	New South Wales
Australia	Novartis Investigative Site	Perth	Western Australia
Australia	Novartis Investigative Site	Port Macquarie	New South Wales
Australia	Novartis Investigative Site	South Brisbane	Queensland
Australia	Novartis Investigative Site	Waratah	New South Wales
Australia	Novartis Investigative Site	Westmead	New South Wales
Australia	Novartis Investigative Site	Wodonga	Victoria
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Innsbruck
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	Vienna
Belgium	Novartis Investigative Site	Brussel
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Charleroi
Belgium	Novartis Investigative Site	Edegem
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Haine Saint Paul
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Liège
Belgium	Novartis Investigative Site	Wilrijk
Belgium	Novartis Investigative Site	Yvoir
Brazil	Novartis Investigative Site	Jau	São Paulo
Brazil	Novartis Investigative Site	Porto Alegre	Rio Grande Do Sul
Brazil	Novartis Investigative Site	Porto Alegre	Rio Grande Do Sul
Brazil	Novartis Investigative Site	Porto Alegre	Rio Grande Do Sul
Brazil	Novartis Investigative Site	Rio de Janeiro
Brazil	Novartis Investigative Site	Rio de Janeiro
Brazil	Novartis Investigative Site	Salvador	Bahía
Brazil	Novartis Investigative Site	São Paulo
Bulgaria	Novartis Investigative Site	Sofia
Canada	Novartis Investigative Site	Greenfield Park	Quebec
Canada	Novartis Investigative Site	Moncton	New Brunswick
Canada	Novartis Investigative Site	Oshawa	Ontario
Canada	Novartis Investigative Site	Saskatoon	Saskatchewan
Canada	Novartis Investigative Site	Sudbury	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
Canada	Novartis Investigative Site	Winnipeg	Manitoba
Chile	Novartis Investigative Site	Santiago	Región Metro De Santiago
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Dalian	Liaoning
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Tianjin
China	Novartis Investigative Site	Wuhan	Hubei
Cyprus	Novartis Investigative Site	Strovolos
Czech Republic	Novartis Investigative Site	Brno
Czech Republic	Novartis Investigative Site	Olomouc
Czech Republic	Novartis Investigative Site	Praha
Czech Republic	Novartis Investigative Site	Praha
Denmark	Novartis Investigative Site	Århus C
Denmark	Novartis Investigative Site	Copenhagen
Denmark	Novartis Investigative Site	Odense C
Denmark	Novartis Investigative Site	Roskilde
Denmark	Novartis Investigative Site	Vejle
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
Finland	Novartis Investigative Site	Hämeenlinna
Finland	Novartis Investigative Site	Helsinki
Finland	Novartis Investigative Site	Kangasala
Finland	Novartis Investigative Site	Kuopio
Finland	Novartis Investigative Site	OYS
Germany	Novartis Investigative Site	Augsburg	Bayern
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bonn	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Braunschweig	Niedersachsen
Germany	Novartis Investigative Site	Duesseldorf	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Halle	Sachsen-Anhalt
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover	Niedersachsen
Germany	Novartis Investigative Site	Ibbenbueren	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Koeln	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Luebeck	Schleswig-Holstein
Germany	Novartis Investigative Site	Magdeburg	Sachsen-Anhalt
Germany	Novartis Investigative Site	Mainz	Rheinland-Pfalz
Germany	Novartis Investigative Site	Mannheim	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Marburg	Hessen
Germany	Novartis Investigative Site	Moenchengladbach	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Saarbruecken	Saarland
Germany	Novartis Investigative Site	Stuttgart	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Troisdorf	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Tuebingen	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Wiesbaden	Hessen
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Heraklion, Crete
Greece	Novartis Investigative Site	Maroussi
Hong Kong	Novartis Investigative Site	Pokfulam
Hong Kong	Novartis Investigative Site	Shatin
Iceland	Novartis Investigative Site	Reykjavik
Indonesia	Novartis Investigative Site	Jakarta
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Galway
Ireland	Novartis Investigative Site	Tallaght, Dublin
Ireland	Novartis Investigative Site	Wilton, Cork
Israel	Novartis Investigative Site	Beer-Sheva
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Petach Tikva
Israel	Novartis Investigative Site	Ramat Gan
Israel	Novartis Investigative Site	Rehovot
Israel	Novartis Investigative Site	Tel Aviv
Italy	Novartis Investigative Site	Ancona
Italy	Novartis Investigative Site	Aviano (PN)	Friuli-Venezia-Giulia
Italy	Novartis Investigative Site	Bari	Puglia
Italy	Novartis Investigative Site	Bergamo	Lombardia
Italy	Novartis Investigative Site	Bolzano	Trentino-Alto Adige
Italy	Novartis Investigative Site	Cagliari
Italy	Novartis Investigative Site	Candiolo (TO)	Piemonte
Italy	Novartis Investigative Site	Chieti
Italy	Novartis Investigative Site	Firenze	Toscana
Italy	Novartis Investigative Site	Forlì	Emilia-Romagna
Italy	Novartis Investigative Site	Genova	Liguria
Italy	Novartis Investigative Site	Macerata
Italy	Novartis Investigative Site	Milano	Lombardia
Italy	Novartis Investigative Site	Milano	Lombardia
Italy	Novartis Investigative Site	Modena	Emilia-Romagna
Italy	Novartis Investigative Site	Napoli	Campania
Italy	Novartis Investigative Site	Padova
Italy	Novartis Investigative Site	Palermo	Sicilia
Italy	Novartis Investigative Site	Perugia	Umbria
Italy	Novartis Investigative Site	Pisa	Toscana
Italy	Novartis Investigative Site	Potenza	Basilicata
Italy	Novartis Investigative Site	Reggio Calabria	Calabria
Italy	Novartis Investigative Site	Roma	Lazio
Italy	Novartis Investigative Site	San Giovanni Rotondo (FG)	Puglia
Italy	Novartis Investigative Site	Torino	Piemonte
Italy	Novartis Investigative Site	Trieste
Korea, Republic of	Novartis Investigative Site	Kyunggi-do
Korea, Republic of	Novartis Investigative Site	Pusan
Korea, Republic of	Novartis Investigative Site	seodaemun-gu, Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	songpa-gu, Seoul
Luxembourg	Novartis Investigative Site	Luxembourg
Malaysia	Novartis Investigative Site	Kuala Lumpur
Malaysia	Novartis Investigative Site	Kuala Lumpur
Malaysia	Novartis Investigative Site	Petaling Jaya Selangor
Malta	Novartis Investigative Site	Floriana
Mexico	Novartis Investigative Site	Durango
Mexico	Novartis Investigative Site	Merida	Yucatán
Mexico	Novartis Investigative Site	Mexico City
Mexico	Novartis Investigative Site	Tijuana	Baja California Norte
Mexico	Novartis Investigative Site	Toluca, Edo Mex	Estado de México
Netherlands	Novartis Investigative Site	Amersfoort
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Dordrecht
Netherlands	Novartis Investigative Site	Enschede
Netherlands	Novartis Investigative Site	Groningen
Netherlands	Novartis Investigative Site	Leeuwarden
Netherlands	Novartis Investigative Site	Leiden
Netherlands	Novartis Investigative Site	Maastricht
New Zealand	Novartis Investigative Site	Christchurch
New Zealand	Novartis Investigative Site	Dunedin
New Zealand	Novartis Investigative Site	Newtown, Wellington
Peru	Novartis Investigative Site	Lima
Peru	Novartis Investigative Site	Lima
Philippines	Novartis Investigative Site	Makati City
Philippines	Novartis Investigative Site	Pasay City
Philippines	Novartis Investigative Site	Quezon City
Philippines	Novartis Investigative Site	Sampaloc Manila
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Bydgoszcz
Poland	Novartis Investigative Site	Elblag
Poland	Novartis Investigative Site	Gdansk
Poland	Novartis Investigative Site	Gliwice
Poland	Novartis Investigative Site	Olsztyn
Poland	Novartis Investigative Site	Olsztyn
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Warszawa
Portugal	Novartis Investigative Site	Evora
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Porto
Portugal	Novartis Investigative Site	Porto
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Iasi
Romania	Novartis Investigative Site	Sibiu
Romania	Novartis Investigative Site	Timisoara
Russian Federation	Novartis Investigative Site	Irkutsk
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Nizhny Novgorod
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Banska Bystrica
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Poprad
Slovenia	Novartis Investigative Site	Ljubljana
Slovenia	Novartis Investigative Site	Maribor
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Basurto/Bilbao
Spain	Novartis Investigative Site	Burgos
Spain	Novartis Investigative Site	Caceres
Spain	Novartis Investigative Site	Elche
Spain	Novartis Investigative Site	Girona
Spain	Novartis Investigative Site	Jaén
Spain	Novartis Investigative Site	Lerida
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga
Spain	Novartis Investigative Site	Murcia
Spain	Novartis Investigative Site	Palencia
Spain	Novartis Investigative Site	Palma de Mallorca
Spain	Novartis Investigative Site	Pamplona
Spain	Novartis Investigative Site	Pontevedra
Spain	Novartis Investigative Site	San Sebastián
Spain	Novartis Investigative Site	Santa Cruz de Tenerife
Spain	Novartis Investigative Site	Santiago
Spain	Novartis Investigative Site	Toledo
Spain	Novartis Investigative Site	Valencia
Spain	Novartis Investigative Site	Valencia
Spain	Novartis Investigative Site	Zaragoza
Sweden	Novartis Investigative Site	Jonkoping
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Umeå
Sweden	Novartis Investigative Site	Uppsala
Switzerland	Novartis Investigative Site	Basel
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Chur
Switzerland	Novartis Investigative Site	Geneve
Switzerland	Novartis Investigative Site	Mendrisio
Switzerland	Novartis Investigative Site	Neuchatel
Switzerland	Novartis Investigative Site	St Gallen
Switzerland	Novartis Investigative Site	Zuerich
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Tainan
Taiwan	Novartis Investigative Site	Tainan County
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Chiang Mai
Thailand	Novartis Investigative Site	Pathumthani
Ukraine	Novartis Investigative Site	Chernivtsi
Ukraine	Novartis Investigative Site	Kiev
Ukraine	Novartis Investigative Site	Odessa
Ukraine	Novartis Investigative Site	Rovno
United Kingdom	Novartis Investigative Site	Belfast
United Kingdom	Novartis Investigative Site	Bournemouth
United Kingdom	Novartis Investigative Site	Brighton
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigative Site	Cambridge	Cambridgeshire
United Kingdom	Novartis Investigative Site	Cardiff
United Kingdom	Novartis Investigative Site	Chelmsford	Essex
United Kingdom	Novartis Investigative Site	Cheltenham
United Kingdom	Novartis Investigative Site	Colchester
United Kingdom	Novartis Investigative Site	Cumbria
United Kingdom	Novartis Investigative Site	Denbighshire
United Kingdom	Novartis Investigative Site	Edinburgh	Midlothian
United Kingdom	Novartis Investigative Site	Hartshill, Stoke-on-Trent
United Kingdom	Novartis Investigative Site	Lindley, huddersfield
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	Northwood	Middlesex
United Kingdom	Novartis Investigative Site	Nottingham
United Kingdom	Novartis Investigative Site	Peterborough
United Kingdom	Novartis Investigative Site	Poole, Dorset
United Kingdom	Novartis Investigative Site	Portsmouth
United Kingdom	Novartis Investigative Site	Shrewsbury
United States	Novartis Investigative Site	Anchorage	Alaska
United States	Novartis Investigative Site	Ann Arbor	Michigan
United States	Novartis Investigative Site	Arlington	Texas
United States	Novartis Investigative Site	Asheville	North Carolina
United States	Novartis Investigative Site	Augusta	Georgia
United States	Novartis Investigative Site	Aurora	Colorado
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Baton Rouge	Louisiana
United States	Novartis Investigative Site	Bellflower	California
United States	Novartis Investigative Site	Bettendorf	Iowa
United States	Novartis Investigative Site	Billings	Montana
United States	Novartis Investigative Site	Bismarck	North Dakota
United States	Novartis Investigative Site	Boise	Idaho
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Boulder	Colorado
United States	Novartis Investigative Site	Brunswick	Georgia
United States	Novartis Investigative Site	Buffalo	New York
United States	Novartis Investigative Site	Buffalo	New York
United States	Novartis Investigative Site	Burbank	California
United States	Novartis Investigative Site	Cedar Rapids	Iowa
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Chevy Chase	Maryland
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Columbia	South Carolina
United States	Novartis Investigative Site	Columbia	Missouri
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Council Bluffs	Iowa
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Decatur	Illinois
United States	Novartis Investigative Site	Detroit	Michigan
United States	Novartis Investigative Site	Drexel Hill	Pennsylvania
United States	Novartis Investigative Site	Duluth	Minnesota
United States	Novartis Investigative Site	East Setauket	New York
United States	Novartis Investigative Site	East Syracuse	New York
United States	Novartis Investigative Site	El Paso	Texas
United States	Novartis Investigative Site	Exeter	New Hampshire
United States	Novartis Investigative Site	Fairfax	Virginia
United States	Novartis Investigative Site	Fall River	Massachusetts
United States	Novartis Investigative Site	Fargo	North Dakota
United States	Novartis Investigative Site	Fayetteville	North Carolina
United States	Novartis Investigative Site	Fayetteville	Arkansas
United States	Novartis Investigative Site	Flemington	New Jersey
United States	Novartis Investigative Site	Florence	South Carolina
United States	Novartis Investigative Site	Fort Lauderdale	Florida
United States	Novartis Investigative Site	Fort Myers	Florida
United States	Novartis Investigative Site	Fort Walton Beach	Florida
United States	Novartis Investigative Site	Frederick	Maryland
United States	Novartis Investigative Site	Freehold	New Jersey
United States	Novartis Investigative Site	Fresh Meadows	New York
United States	Novartis Investigative Site	Gainesville	Florida
United States	Novartis Investigative Site	Galesburg	Illinois
United States	Novartis Investigative Site	Gilroy	California
United States	Novartis Investigative Site	Glendale	Arizona
United States	Novartis Investigative Site	Glens Falls	New York
United States	Novartis Investigative Site	Grand Island	Nebraska
United States	Novartis Investigative Site	Great Falls	Montana
United States	Novartis Investigative Site	Green Bay	Wisconsin
United States	Novartis Investigative Site	Greensboro	North Carolina
United States	Novartis Investigative Site	Hartford	Connecticut
United States	Novartis Investigative Site	Highland Park	Illinois
United States	Novartis Investigative Site	Hollywood	Florida
United States	Novartis Investigative Site	Honolulu	Hawaii
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Huntsville	Alabama
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Jackson	Mississippi
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Joliet	Illinois
United States	Novartis Investigative Site	Kalamazoo	Missouri
United States	Novartis Investigative Site	Kansas City	Missouri
United States	Novartis Investigative Site	Kennewick	Washington
United States	Novartis Investigative Site	Klamath Falls	Oregon
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	La Crosse	Wisconsin
United States	Novartis Investigative Site	Lafayette	Colorado
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Little Silver	New Jersey
United States	Novartis Investigative Site	Livingston	New Jersey
United States	Novartis Investigative Site	Long Beach	California
United States	Novartis Investigative Site	Long Beach	California
United States	Novartis Investigative Site	Macon	Georgia
United States	Novartis Investigative Site	Manchester	Connecticut
United States	Novartis Investigative Site	Marietta	Georgia
United States	Novartis Investigative Site	Marshfield	Wisconsin
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Metairie	Louisiana
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Morgantown	West Virginia
United States	Novartis Investigative Site	Mount Vernon	Washington
United States	Novartis Investigative Site	Mountain Lakes	New Jersey
United States	Novartis Investigative Site	Mt. Pleasant	South Carolina
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	New Havey	Connecticut
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Newark	New Jersey
United States	Novartis Investigative Site	Newport Beach	California
United States	Novartis Investigative Site	North Platte	Nebraska
United States	Novartis Investigative Site	Norwich	Connecticut
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Orlando	Florida
United States	Novartis Investigative Site	Orlando	Florida
United States	Novartis Investigative Site	Peabody	Massachusetts
United States	Novartis Investigative Site	Peoria	Illinois
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Portland	Maine
United States	Novartis Investigative Site	Pottstown	Pennsylvania
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	Royal Oak	Michigan
United States	Novartis Investigative Site	Salt Lake City	Utah
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	San Francisco	California
United States	Novartis Investigative Site	Sandusky	Ohio
United States	Novartis Investigative Site	Santa Rosa	California
United States	Novartis Investigative Site	Sayre	Pennsylvania
United States	Novartis Investigative Site	Scarborough	Maine
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Sioux City	Iowa
United States	Novartis Investigative Site	Springfield	Missouri
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	State College	Pennsylvania
United States	Novartis Investigative Site	Stockton	California
United States	Novartis Investigative Site	Tacoma	Washington
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Troy	Michigan
United States	Novartis Investigative Site	Tucker	Georgia
United States	Novartis Investigative Site	Tulsa	Oklahoma
United States	Novartis Investigative Site	Tulsa	Oklahoma
United States	Novartis Investigative Site	Walla Walla	Washington
United States	Novartis Investigative Site	Washington	District of Columbia
United States	Novartis Investigative Site	Waterloo	Iowa
United States	Novartis Investigative Site	Waterville	Maine
United States	Novartis Investigative Site	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Cyprus,  Czech Republic,  Denmark,  Estonia,  Finland,  Germany,  Greece,  Hong Kong,  Iceland,  Indonesia,  Ireland,  Israel,  Italy,  Korea, Republic of,  Luxembourg,  Malaysia,  Malta,  Mexico,  Netherlands,  New Zealand,  Peru,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Singapore,  Slovakia,  Slovenia,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Ukraine,  United Kingdom,