Clinical trial NCT00490139: ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
Official title: A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neoplasms, Breast
Keywords: Adjuvant
ErbB2-overexpressing
Early stage breast cancer
HER2/neu gene amplified
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: North Central Cancer Treatment Group
name: National Cancer Institute (NCI)
name: Breast International Group
name: Canadian Cancer Trials Group
First posted: 2007-06-22
Enrollment: 8381
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: This was a four-arm (parallel group) randomized, open-label, multicenter Phase 3 study to investigate the use of a combination of Lapatinib and Trastuzumab, a sequence of Trastuzumab followed by Lapatinib, and Lapatinib alone, compared to Trastuzumab alone in the adjuvant treatment of Human Epidermal Growth Factor Receptor 2 (HER2) positive early breast cancer.

Detailed description: Treatment allocation was stratified by blocked randomization, with three stratification factors:

* Hormone receptor status: Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) positive versus both negative.
* Axillary lymph node involvement: not assessed because of neoadjuvant chemotherapy versus node negative versus 1-3 positive nodes versus 4 or more positive nodes.
* Timing of adjuvant chemotherapy: concurrently with taxanes and targeted therapy (Design 2) and concurrently with non-anthracycline-based platinum chemotherapy and targeted therapy (Design 2B) versus all other chemotherapy completed before randomization (Design 1). Treatments delivered differed according to the timing and type of adjuvant chemotherapy.

The primary objective of this study was to compare disease-free survival (DFS) in subjects with HER2 overexpressing and/or amplified breast cancer randomized to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks).

Secondary objectives included treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, and incidence of brain metastasis.

Based on the recommendation of the Independent Data Monitoring Committee (IDMC) at the first interim analysis (18-Aug-2011), the Lapatinib alone arm was discontinued prior to primary analysis due to futility. The IDMC also stated that the other three arms (trastuzumab alone, sequential trastuzumab/lapatinib arm and the combination arm) could continued as planned with no changes.

Eligibility criteria: Key Inclusion Criteria:

* Patients \>= 18 years of age with histologically confirmed, non-metastatic, operable and over expression/amplification of HER2 (3+ by IHC and/or FISH positive) primary breast cancer, treated with definitive surgery, with baseline LVEF \>= 50%, known hormone receptor status (ER/PgR or ER alone) and ECOG performance status =\< 1, were included.
* For Designs 1 and 2: Patients must have had received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen or a protocol specified exception.
* Approved, signed written informed consent obtained prior to any study specific screening procedures.

Key Exclusion Criteria:

* History of any prior (ipsi- and/or contralateral) invasive breast carcinoma, past (less than 10 years) or current history of malignant neoplasms, any clinically staged T4 tumor, or bilateral tumors.
* Concurrent anti-cancer treatment, except hormonal therapy or radiotherapy for the present breast cancer;
* Patients with positive or suspicious internal mammary nodes identified by sentinel node technique, which had not been irradiated or would not be irradiated, or patients with supraclavicular lymph node involvement.
* Any prior anti-HER therapy, which includes agents that target other members of the HER family of receptors, e.g. gefitinib (Iressa)
* (Neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support;
* Serious cardiac illness or medical conditions.
* Any of the following abnormal laboratory tests immediately prior to randomization:

  1. Serum total bilirubin \>1.5 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (\<2 x ULN) was allowed;
  2. Alanine amino transferase (ALT) or aspartate amino transferase (AST) \>2.5 x ULN;
  3. Alkaline phosphatase (ALP) \>2.5 x ULN;
  4. Serum creatinine \>2.0 x ULN;
  5. Total white blood cell count (WBC) \<2.5 x 10\^9/L;
  6. Absolute neutrophil count \<1.5 x 10\^9/L;
  7. Platelets \<100 x 10\^9/L.
* Women of childbearing potential and male patients with partners of childbearing potential, who are unable or unwilling to use adequate contraceptive measures during study treatment, and pregnant or lactating women.
* Concomitant use of CYP3A4 inhibitors or inducers.

Primary outcomes:
measure: Disease-Free Survival (DFS) at the Primary Analysis
timeFrame: From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)
Secondary outcomes:
measure: Disease-Free Survival (DFS) at the 10-Year Follow-Up
timeFrame: From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause, assessed up to approximately 10 years
measure: Overall Survival (OS) at the Primary Analysis
timeFrame: From randomization until death due to any cause (median follow-up of 4.5 years)
measure: Overall Survival (OS) at the 10-Year Follow-Up
timeFrame: From randomization until death due to any cause, assessed up to approximately 10 years
measure: Analysis of Time to Recurrence (TTR)
timeFrame: From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years
measure: Analysis of Time to Distant Recurrence (TTDR)
timeFrame: From randomization until the date of the first occurrence of distant recurrence, assessed up to approximately 10 years
measure: Analysis of Time to Central Nervous System (CNS) Recurrence
timeFrame: From randomization until the first central nervous system recurrence, assessed up to approximately 10 years
measure: Cumulative Incidence of Brain Metastases
timeFrame: From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years
Other outcomes:
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city: Rapid City
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city: Chattanooga
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city: Chattanooga
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state: Tennessee
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state: Tennessee
city: Nashville
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state: Tennessee
city: Nashville
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state: Tennessee
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state: Texas
city: Bedford
country: United States
facility: Novartis Investigative Site
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facility: Novartis Investigative Site
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facility: Novartis Investigative Site
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facility: Novartis Investigative Site
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facility: Novartis Investigative Site
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city: Offenbach
country: Germany
facility: Novartis Investigative Site
city: Oldenburg
country: Germany
facility: Novartis Investigative Site
city: Oldenburg
country: Germany
facility: Novartis Investigative Site
city: Olpe
country: Germany
facility: Novartis Investigative Site
city: Osnabrueck
country: Germany
facility: Novartis Investigative Site
city: Ostfildern
country: Germany
facility: Novartis Investigative Site
city: Porta Westfalica
country: Germany
facility: Novartis Investigative Site
city: Radebeul
country: Germany
facility: Novartis Investigative Site
city: Ravensburg
country: Germany
facility: Novartis Investigative Site
city: Rendsburg
country: Germany
facility: Novartis Investigative Site
city: Reutlingen
country: Germany
facility: Novartis Investigative Site
city: Rheinfelden
country: Germany
facility: Novartis Investigative Site
city: Rodewisch
country: Germany
facility: Novartis Investigative Site
city: Rosenheim
country: Germany
facility: Novartis Investigative Site
city: Rostock
country: Germany
facility: Novartis Investigative Site
city: Rotenburg
country: Germany
facility: Novartis Investigative Site
city: Saarbruecken
country: Germany
facility: Novartis Investigative Site
city: Schkeuditz
country: Germany
facility: Novartis Investigative Site
city: Schwaebisch Hall
country: Germany
facility: Novartis Investigative Site
city: Sigmaringen
country: Germany
facility: Novartis Investigative Site
city: Stade
country: Germany
facility: Novartis Investigative Site
city: Stadthagen
country: Germany
facility: Novartis Investigative Site
city: Stendal
country: Germany
facility: Novartis Investigative Site
city: Stralsund
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Torgau
country: Germany
facility: Novartis Investigative Site
city: Trier
country: Germany
facility: Novartis Investigative Site
city: Troisdorf
country: Germany
facility: Novartis Investigative Site
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Vechta
country: Germany
facility: Novartis Investigative Site
city: Velbert
country: Germany
facility: Novartis Investigative Site
city: Villingen-Schwenningen
country: Germany
facility: Novartis Investigative Site
city: Weissenfels
country: Germany
facility: Novartis Investigative Site
city: Wesel
country: Germany
facility: Novartis Investigative Site
city: Westerstede
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Witten
country: Germany
facility: Novartis Investigative Site
city: Wuerselen
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
city: Wuppertal
country: Germany
facility: Novartis Investigative Site
city: Wuppertal
country: Germany
facility: Novartis Investigative Site
city: Zittau
country: Germany
facility: Novartis Investigative Site
city: Zwickau
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Heraklion
country: Greece
facility: Novartis Investigative Site
city: Patra
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Kowloon
country: Hong Kong
facility: Novartis Investigative Site
city: Tuen Mun
country: Hong Kong
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Gyor
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Gurgaon
country: India
facility: Novartis Investigative Site
city: Hyderabad
country: India
facility: Novartis Investigative Site
city: Kolkatta
country: India
facility: Novartis Investigative Site
city: Mumbai
country: India
facility: Novartis Investigative Site
city: Nagpur
country: India
facility: Novartis Investigative Site
city: New Delhi
country: India
facility: Novartis Investigative Site
city: New Delhi
country: India
facility: Novartis Investigative Site
city: Trivandrum
country: India
facility: Novartis Investigative Site
city: Cork
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Galway
country: Ireland
facility: Novartis Investigative Site
city: Beer-Sheva
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Holon
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Netanya
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
city: Zrifin
country: Israel
facility: Novartis Investigative Site
city: Asti
country: Italy
facility: Novartis Investigative Site
city: Avellino
country: Italy
facility: Novartis Investigative Site
city: Aviano
country: Italy
facility: Novartis Investigative Site
city: Bergamo
country: Italy
facility: Novartis Investigative Site
city: Biella
country: Italy
facility: Novartis Investigative Site
city: Brescia
country: Italy
facility: Novartis Investigative Site
city: Brescia
country: Italy
facility: Novartis Investigative Site
city: Brindisi
country: Italy
facility: Novartis Investigative Site
city: Candiolo
country: Italy
facility: Novartis Investigative Site
city: Carpi
country: Italy
facility: Novartis Investigative Site
city: Cosenza
country: Italy
facility: Novartis Investigative Site
city: Cremona
country: Italy
facility: Novartis Investigative Site
city: Fano
country: Italy
facility: Novartis Investigative Site
city: Fermo
country: Italy
facility: Novartis Investigative Site
city: Firenze
country: Italy
facility: Novartis Investigative Site
city: Genova
country: Italy
facility: Novartis Investigative Site
city: Lecce
country: Italy
facility: Novartis Investigative Site
city: Lecco
country: Italy
facility: Novartis Investigative Site
city: Lido di Camaiore
country: Italy
facility: Novartis Investigative Site
city: Livorno
country: Italy
facility: Novartis Investigative Site
city: Mantova
country: Italy
facility: Novartis Investigative Site
city: Meldola
country: Italy
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
city: Monserrato
country: Italy
facility: Novartis Investigative Site
city: Monza
country: Italy
facility: Novartis Investigative Site
city: Pavia
country: Italy
facility: Novartis Investigative Site
city: Poggibonsi
country: Italy
facility: Novartis Investigative Site
city: Potenza
country: Italy
facility: Novartis Investigative Site
city: Prato
country: Italy
facility: Novartis Investigative Site
city: Ragusa
country: Italy
facility: Novartis Investigative Site
city: Ravenna
country: Italy
facility: Novartis Investigative Site
city: Rimini
country: Italy
facility: Novartis Investigative Site
city: Rozzano
country: Italy
facility: Novartis Investigative Site
city: San Fermo della Battaglia
country: Italy
facility: Novartis Investigative Site
city: Saronno
country: Italy
facility: Novartis Investigative Site
city: Sassari
country: Italy
facility: Novartis Investigative Site
city: Trento
country: Italy
facility: Novartis Investigative Site
city: Treviglio
country: Italy
facility: Novartis Investigative Site
city: Udine
country: Italy
facility: Novartis Investigative Site
city: Varese
country: Italy
facility: Novartis Investigative Site
city: Viterbo
country: Italy
facility: Novartis Investigative Site
city: Aichi
country: Japan
facility: Novartis Investigative Site
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Ehime
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Ibaraki
country: Japan
facility: Novartis Investigative Site
city: Kanagawa
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novartis Investigative Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novartis Investigative Site
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Chihuahua
country: Mexico
facility: Novartis Investigative Site
city: Mexico City
country: Mexico
facility: Novartis Investigative Site
city: Mexico
country: Mexico
facility: Novartis Investigative Site
city: Toluca
country: Mexico
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Arnhem
country: Netherlands
facility: Novartis Investigative Site
city: Delft
country: Netherlands
facility: Novartis Investigative Site
city: Den Haag
country: Netherlands
facility: Novartis Investigative Site
city: Den Haag
country: Netherlands
facility: Novartis Investigative Site
city: Eindhoven
country: Netherlands
facility: Novartis Investigative Site
city: Gouda
country: Netherlands
facility: Novartis Investigative Site
city: Hilversum
country: Netherlands
facility: Novartis Investigative Site
city: Hoogeveen
country: Netherlands
facility: Novartis Investigative Site
city: Leeuwarden
country: Netherlands
facility: Novartis Investigative Site
city: Leiden
country: Netherlands
facility: Novartis Investigative Site
city: Leidschendam
country: Netherlands
facility: Novartis Investigative Site
city: Purmerend
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Sittard-Geleen
country: Netherlands
facility: Novartis Investigative Site
city: Tilburg
country: Netherlands
facility: Novartis Investigative Site
city: Utrecht
country: Netherlands
facility: Novartis Investigative Site
city: Hamilton
country: New Zealand
facility: Novartis Investigative Site
city: Palmerston North
country: New Zealand
facility: Novartis Investigative Site
city: Wellington
country: New Zealand
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Tromso
country: Norway
facility: Novartis Investigative Site
city: Karachi
country: Pakistan
facility: Novartis Investigative Site
city: Karachi
country: Pakistan
facility: Novartis Investigative Site
city: Lahore
country: Pakistan
facility: Novartis Investigative Site
city: Lahore
country: Pakistan
facility: Novartis Investigative Site
city: Rawalpindi
country: Pakistan
facility: Novartis Investigative Site
city: Callao
country: Peru
facility: Novartis Investigative Site
city: Lima
country: Peru
facility: Novartis Investigative Site
city: Lima
country: Peru
facility: Novartis Investigative Site
city: Lima
country: Peru
facility: Novartis Investigative Site
city: Cebu
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Sampaloc
country: Philippines
facility: Novartis Investigative Site
city: San Juan
country: Philippines
facility: Novartis Investigative Site
city: Bydgoszcz
country: Poland
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Gliwice
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Olsztyn
country: Poland
facility: Novartis Investigative Site
city: Olsztyn
country: Poland
facility: Novartis Investigative Site
city: Opole
country: Poland
facility: Novartis Investigative Site
city: Rzeszow
country: Poland
facility: Novartis Investigative Site
city: Szczecin
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Cluj-Napoca
country: Romania
facility: Novartis Investigative Site
city: Iasi
country: Romania
facility: Novartis Investigative Site
city: Arkhangelsk
country: Russian Federation
facility: Novartis Investigative Site
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Irkutsk
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Kirov
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Novosibirsk
country: Russian Federation
facility: Novartis Investigative Site
city: Omsk
country: Russian Federation
facility: Novartis Investigative Site
city: Orenburg
country: Russian Federation
facility: Novartis Investigative Site
city: Ryazan
country: Russian Federation
facility: Novartis Investigative Site
city: Samara
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Voronezh
country: Russian Federation
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Poprad
country: Slovakia
facility: Novartis Investigative Site
city: Zilina
country: Slovakia
facility: Novartis Investigative Site
city: Ljubljana
country: Slovenia
facility: Novartis Investigative Site
city: Capital Park
country: South Africa
facility: Novartis Investigative Site
city: Groenkloof
country: South Africa
facility: Novartis Investigative Site
city: Johannesburg
country: South Africa
facility: Novartis Investigative Site
city: Observatory
country: South Africa
facility: Novartis Investigative Site
city: Panorama
country: South Africa
facility: Novartis Investigative Site
city: Parktown
country: South Africa
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Alcoy
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Burgos
country: Spain
facility: Novartis Investigative Site
city: Cadiz
country: Spain
facility: Novartis Investigative Site
city: Castellon
country: Spain
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
city: Elda
country: Spain
facility: Novartis Investigative Site
city: Granada
country: Spain
facility: Novartis Investigative Site
city: Lerida
country: Spain
facility: Novartis Investigative Site
city: Lugo
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
city: Mataro
country: Spain
facility: Novartis Investigative Site
city: Mostoles
country: Spain
facility: Novartis Investigative Site
city: Murcia
country: Spain
facility: Novartis Investigative Site
city: Palma de Mallorca
country: Spain
facility: Novartis Investigative Site
city: Palma de Mallorca
country: Spain
facility: Novartis Investigative Site
city: Pamplona
country: Spain
facility: Novartis Investigative Site
city: Salamanca
country: Spain
facility: Novartis Investigative Site
city: San Sebastian
country: Spain
facility: Novartis Investigative Site
city: Santa Cruz de Tenerife
country: Spain
facility: Novartis Investigative Site
city: Santander
country: Spain
facility: Novartis Investigative Site
city: Santiago
country: Spain
facility: Novartis Investigative Site
city: Segovia
country: Spain
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
city: Tarrasa, Barcelona
country: Spain
facility: Novartis Investigative Site
city: Toledo
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Vizcaya
country: Spain
facility: Novartis Investigative Site
city: Zamora
country: Spain
facility: Novartis Investigative Site
city: Aarau
country: Switzerland
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Bellinzona
country: Switzerland
facility: Novartis Investigative Site
city: Chur
country: Switzerland
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
city: Locarno
country: Switzerland
facility: Novartis Investigative Site
city: St Gallen
country: Switzerland
facility: Novartis Investigative Site
city: Thun
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Zurich
country: Switzerland
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Tainan County
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiangmai
country: Thailand
facility: Novartis Investigative Site
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
city: Phitsanulok
country: Thailand
facility: Novartis Investigative Site
city: Songkhla
country: Thailand
facility: Novartis Investigative Site
city: Chernivtsi
country: Ukraine
facility: Novartis Investigative Site
city: Donetsk
country: Ukraine
facility: Novartis Investigative Site
city: Kharkiv
country: Ukraine
facility: Novartis Investigative Site
city: Kyiv
country: Ukraine
facility: Novartis Investigative Site
city: Lviv
country: Ukraine
facility: Novartis Investigative Site
city: Simferopol
country: Ukraine
facility: Novartis Investigative Site
city: Uzhgorod
country: Ukraine
facility: Novartis Investigative Site
city: Uzhorod
country: Ukraine
facility: Novartis Investigative Site
city: Canterbury
country: United Kingdom
facility: Novartis Investigative Site
state: Kent
city: Blackpool
country: United Kingdom
facility: Novartis Investigative Site
city: Bournemouth
country: United Kingdom
facility: Novartis Investigative Site
city: Brighton
country: United Kingdom
facility: Novartis Investigative Site
city: Cardiff
country: United Kingdom
facility: Novartis Investigative Site
city: Chelmsford
country: United Kingdom
facility: Novartis Investigative Site
city: Cheltenham
country: United Kingdom
facility: Novartis Investigative Site
city: Cottingham
country: United Kingdom
facility: Novartis Investigative Site
city: Dorchester
country: United Kingdom
facility: Novartis Investigative Site
city: Edinburgh
country: United Kingdom
facility: Novartis Investigative Site
city: Exeter
country: United Kingdom
facility: Novartis Investigative Site
city: Grimsby
country: United Kingdom
facility: Novartis Investigative Site
city: Guildford
country: United Kingdom
facility: Novartis Investigative Site
city: Gwynedd
country: United Kingdom
facility: Novartis Investigative Site
city: Huddersfield
country: United Kingdom
facility: Novartis Investigative Site
city: Ipswich
country: United Kingdom
facility: Novartis Investigative Site
city: Lancaster
country: United Kingdom
facility: Novartis Investigative Site
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Maidstone
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
city: Northwood
country: United Kingdom
facility: Novartis Investigative Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
city: Oxford
country: United Kingdom
facility: Novartis Investigative Site
city: Plymouth
country: United Kingdom
facility: Novartis Investigative Site
city: Poole
country: United Kingdom
facility: Novartis Investigative Site
city: Portsmouth
country: United Kingdom
facility: Novartis Investigative Site
city: Preston
country: United Kingdom
facility: Novartis Investigative Site
city: Prittlewell Chase
country: United Kingdom
facility: Novartis Investigative Site
city: Romford
country: United Kingdom
facility: Novartis Investigative Site
city: Sheffield
country: United Kingdom
facility: Novartis Investigative Site
city: Shrewsbury
country: United Kingdom
facility: Novartis Investigative Site
city: St Helens
country: United Kingdom
facility: Novartis Investigative Site
city: Stoke on Trent
country: United Kingdom
facility: Novartis Investigative Site
city: Sutton
country: United Kingdom
facility: Novartis Investigative Site
city: Swansea
country: United Kingdom
facility: Novartis Investigative Site
city: Worthing
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
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