Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss Without PIK3CA Mutation

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation

ClinicalTrials.gov Identifier: NCT04251533

Novartis Reference Number: CBYL719H12301

Last Update: Feb 26, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss without PIK3CA mutation (Study Parts B1 and B2)

Condition 
Triple Negative Breast Neoplasms
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
566 participants
Start date 
Mar 12, 2020
Completion date 
Nov 24, 2025
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
alpelisib
300 mg orally once per day (QD)
Drug
placebo
300 mg orally once per day (QD)
Drug
nab-paclitaxel
100 mg/m² as IV infusion on Days 1, 8 and 15 of a 28-day cycle

Eligibility Criteria

Inclusion Criteria:

Subject has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy, or metastatic (stage IV)) TNBC
Subject has either a measurable disease per RECIST 1.1 criteria or, if no measurable disease is present, then at least one predominantly lytic bone lesion or mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be evaluated by CT/MRI) must be present Part B1: patients must have measurable disease
Subject has adequate tumor tissue to identify the PIK3CA mutation status (either carrying a mutation or without a mutation) and the PTEN loss status; both of which will determine whether the subject can be allocated to Part A - PIK3CA mutation regardless of PTEN status; or to Part B - PTEN loss without a PIK3CA mutation
Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Subject has received no more than one line of therapy for metastatic disease.
Subject has adequate bone marrow and organ function

Exclusion Criteria:

Subject has received prior treatment with any PI3K, mTOR or AKT inhibitor
Subject has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of their excipients
Subject has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤1; with the exception of alopecia
Subject has central nervous system (CNS) involvement
Subject with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on Fasting Plasma Glucose and HbA1c
Subject has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) based on investigator discretion
Subject has a history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis
Subject has currently documented pneumonitis/interstitial lung disease
Subject has a history of severe cutaneous reactions, such as Steven-Johnson Syndrome (SJS), erythema multiforme (EM),Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS)
Subject with unresolved osteonecrosis of the jaw

Other protocol-defined inclusion/exclusion criteria apply.

Study Locations

United States
University of California at Los Angeles Santa Monica Location
Recruiting
Los Angeles, 90095
California
United States
Fort Wayne Medical Oncology/Hematology, Inc. Jefferson Blvd
Recruiting
Fort Wayne, 46815
Indiana
United States
University of Kansas Hospital and Medical Center DeptofUofKansas CancerCenter-2
Recruiting
Kansas City, 66160
Kansas
United States
Hematology and Oncology Clinic SC
Recruiting
Baton Rouge, 70809
Louisiana
United States
Sinai Hospital of Baltimore Dept of Sinai Hospital - 2
Recruiting
Baltimore, 21215
Maryland
United States
Mayo Clinic Rochester Mayo - Roch.
Recruiting
Rochester, 55905
Minnesota
United States
Research Medical Center HCA Midwest Division
Recruiting
Kansas City, 64132
Missouri
United States
Comprehensive Cancer Centers of Nevada CCC of Nevada (1)
Recruiting
Las Vegas, 89109
Nevada
United States
New York Oncology Hematology, P.C.
Recruiting
Albany, 12206
New York
United States
Cleveland Clinic Foundation Taussig Cancer Center
Recruiting
Cleveland, 44195
Ohio
United States
Tennessee Oncology Tennessee Oncology (3)
Recruiting
Nashville, 37203
Tennessee
United States
Texas Oncology, P.A. Austin
Recruiting
Bedford, 76022
Texas
United States
Texas Oncology PA Dallas Presbyterian Hospital SC
Recruiting
Dallas, 75231
Texas
United States
Texas Oncology Texas Oncology - Denton
Recruiting
Dallas, 75246
Texas
United States
El Paso, Texas Oncology
Recruiting
El Paso, 79902
Texas
United States
Texas Oncology Houston Memorial City SC
Recruiting
Houston, 77024
Texas
United States
Cancer Care Centers of South Texas HOAST CCC of So. TX- San Antonio
Recruiting
San Antonio, 78229
Texas
United States
US Oncology P A
Recruiting
Tyler, 75702
Texas
United States
Virginia Oncology Associates
Recruiting
Norfolk, 23502
Virginia
United States
Northwest Medical Specialties Northwest Medical - Puyallup
Recruiting
Tacoma, 98405
Washington
United States
Australia
Novartis Investigative Site
Recruiting
Melbourne, 3000
Victoria
Australia
Novartis Investigative Site
Recruiting
Murdoch, 6150
Western Australia
Australia
Novartis Investigative Site
Recruiting
Nedlands, 6009
Western Australia
Australia
Austria
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Recruiting
Innsbruck, 6020
Tyrol
Austria
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Salzburg, 5020
-
Austria
Brazil
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Recruiting
Caxias do Sul, 95070-560
RS
Brazil
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Barretos, 14784 400
SP
Brazil
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Sao Paulo, 01317-002
SP
Brazil
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Sao Paulo, 03102-002
SP
Brazil
Bulgaria
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Plovdiv, 4004
-
Bulgaria
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Varna, 9010
-
Bulgaria
Croatia
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Zagreb, 10000
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Croatia
France
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Saint-Cloud, 92210
Hauts De Seine
France
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Angers Cedex 02, 49055
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France
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Besancon Cedex, 25030
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France
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Clermont-Ferrand, 63011
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France
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Creteil, 94010
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France
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Dijon, 21034
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France
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Le Mans, 72000
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France
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Metz, 57085
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France
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Nimes Cedex 9, 30029
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France
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Paris Cedex 10, 75475
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France
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Poitiers, 86000
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France
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Reims, 51100
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France
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Saint-Herblain Cédex, 44805
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France
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Villejuif Cedex, 94800
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France
Germany
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Ravensburg, 88212
Baden-Wuerttemberg
Germany
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Muenchen, 80637
Bavaria
Germany
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Essen, 45136
Nordrhein-Westfalen
Germany
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Velbert, 42551
North Rhine-westphalia
Germany
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Luebeck, 23563
Schleswig-holstein
Germany
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Dresden, 01307
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Germany
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Erlangen, 91054
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Germany
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Hamburg, 20357
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Germany
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Heidelberg, 69120
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Germany
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Leipzig, 04103
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Germany
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Rostock, 18059
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Germany
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Tübingen, 72076
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Germany
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Ulm, 89081
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Germany
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Hungary
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Hungary
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Hungary
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Kecskemet, 6000
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Hungary
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Tatabanya, H 2800
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India
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Faridabad, 121 001
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India
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Mumbai, 400056
Maharashtra
India
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Telangana
India
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Hyderabad, 500082
Telangana
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Israel
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Be'er Sheva, 84101
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Israel
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Ramat Gan, 52621
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Israel
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Tel Aviv, 6423906
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Ancona, 60126
AN
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Meldola, 47014
FC
Italy
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Messina, 98158
ME
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Rionero in Vulture, 85028
PZ
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Roma, 00128
RM
Italy
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Napoli, 80131
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Korea, Republic of
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Seoul, 03080
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Korea, Republic of
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Seoul, 05505
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Korea, Republic of
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Seoul, 06351
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Korea, Republic of
Malaysia
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Petaling Jaya, 46050
Selangor
Malaysia
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Kuala Lumpur, 59100
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Malaysia
Norway
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Oslo, NO 0450
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Norway
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Stavanger, 4019
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Norway
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Tromsoe, 9038
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Norway
Poland
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Gdynia, 81 519
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Poland
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Opole, 45-061
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Poland
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Poznan, 61 485
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Poland
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Rzeszow, 35-021
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Poland
Russian Federation
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Arkhangelsk, 163045
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Russian Federation
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Chelyabinsk, 454048
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Russian Federation
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Moscow, 117997
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Russian Federation
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Moscow, 123056
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Russian Federation
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Moscow, 143423
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Russian Federation
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Pushkin Saint Petersburg, 196603
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Russian Federation
Slovakia
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Bratislava, 812 50
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Slovakia
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Kosice, 041 91
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Slovakia
Spain
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Almeria, 04009
Andalucia
Spain
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Sabadell, 08208
Barcelona
Spain
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Alicante, 03010
Comunidad Valenciana
Spain
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Valencia, 46017
Comunidad Valenciana
Spain
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Badajoz, 06080
Extremadura
Spain
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Palma De Mallorca, 07120
Islas Baleares
Spain
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Ferrol, 15405
-
Spain
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Madrid, 28009
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Spain
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Madrid, 28041
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Spain
Switzerland
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Aarau, 5000
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Switzerland
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Lausanne, 1011
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Switzerland
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Zurich, 8008
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Switzerland
Taiwan
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Taichung, 40447
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Taiwan
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Taipei, 10002
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Taiwan
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Taipei, 10449
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Taiwan
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Taoyuan, 33305
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Taiwan
Turkey
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Istanbul, 34722
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Turkey
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Istanbul, 35100
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Turkey
United Kingdom
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Nottingham, NG5 1PB
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United Kingdom
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Oxford, OX3 7LJ
-
United Kingdom
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Swansea, SA2 8QA
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United Kingdom

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Phone: 
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