Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC
- Trial number:
- NCT05043090
- Trial phase:
- 3
- Study type:
- Immunotherapy, Targeted therapy
- Overall status:
- Recruiting
Study start date
October, 2021
Scientific title
A Phase III, Open Label, Randomised, 3-Arm, Multi-Centre Study of Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (SAMETA)
Summary
A clinical trial to compare the effectiveness of savolitinib plus durvalumab versus sunitinib in MET-driven (hepatocyte growth factor receptor), unresectable and locally advanced or metastatic PRCC (Papillary Renal Cell Carcinoma).
* Histologically confirmed unresectable and locally advanced or metastatic PRCC* PRCC must be centrally confirmed as MET-driven using a sponsor-designated central laboratory validated NGS assay * No prior systemic anti-cancer treatment in the metastatic setting; no prior exposure to MET inhibitors, Durvalumab or Sunitinib in any setting * Karnofsky Score \>70 * At least one lesion, not previously irradiated, that can be accurately measured at baseline * Adequate organ and bone marrow function * Life expectancy ≥12weeks at Day 1
Study design
Primary purpose:
TREATMENT, Allocation:
RANDOMIZED, Intervention model:
PARALLEL, Masking:
NONE,
Conditions
Papillary Renal Cell Carcinoma
Other study ID numbers
2022-503105-38-00; 2021-000336-55; D5086C00001
Choose trial site (237)
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San Miguel de Tucumán, Tucumán, Argentina
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176 Hawkesbury Rd, Westmead NSW 2145, Australia
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R. Ramiro Barcelos, 2350 - Rio Branco, Porto Alegre - RS, 90035-007, Brazil
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Palachovo nám. 5, 625 00 Brno-Starý Lískovec, Czechia
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Zborovská 2089, 500 03 Hradec Králové, Czechia
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Olomouc, Czechia
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Prague 10, Czechia
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Voršilská 144, Staré Město, 110 00 Praha-Praha 1, Czechia
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Prague 8, Czechia
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Prague, Czechia
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Nice, France
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16 Av. Paul Vaillant Couturier, 94800 Villejuif, France
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Piazza della Indipendenza, 18/b, 50129 Firenze FI, Italy
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Seoul, South Korea
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Eduardo Hay 77, Villas de la Convención, 20280 Aguascalientes, Ags., Mexico
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Delicias 1721-A, Mitras Centro, 64460 Monterrey, N.L., Mexico
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Tlaxcala Núm. 151 - 1º Piso Oficina B119, Hipódromo Condesa, Cuauhtémoc, 06100 Ciudad de México, CDMX, Mexico
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Av Fray Luis de León 8071, Centro Sur, 76090 Santiago de Querétaro, Qro., Mexico
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Gdańsk, Poland
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Łużycka 3C, 81-537 Gdynia, Poland
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Andrzeja Sołtana 7, 05-400 Otwock, Poland
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Carrer de Wellington, 30, 08005 Barcelona, Spain
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Tainan City, Taiwan
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Ankara, Turkey
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Charterhouse Square Barts and the London School of Medicine and Dentistry Queen Mary University of London, Barbican, London EC1M 6BQ, UK
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15111 Whittier Blvd #216, Whittier, CA 90603, USA
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6475 Washington St #103, Gurnee, IL 60031, USA
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800 Irving Ave, Syracuse, NY 13210, USA
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Buenos Aires, Argentina
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Córdoba, Cordoba, Argentina
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La Plata, Buenos Aires Province, Argentina
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Rosario, Santa Fe Province, Argentina
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8 Arnold St, Box Hill VIC 3128, Australia
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Suite 1/2-6 Glenferrie Rd, Malvern VIC 3144, Australia
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8/201 Pacific Hwy, St Leonards NSW 2065, Australia
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Belo Horizonte, State of Minas Gerais, Brazil
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Rua Mário Imperial, 39, 2º andar Bairro - Ferroviários, Cachoeiro de Itapemirim - ES, 29308-014, Brazil
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R. Evaristo F. Ferreira da Costa, 383-391 - Jardim das Américas, Curitiba - PR, 82590-300, Brazil
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R. Menino Deus - Centro, Florianópolis - SC, 88020-210, Brazil
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R. Mal. Deodoro - Colina do Sol, Pelotas - RS, 96020-780, Brazil
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Praça Conselheiro Almeida Couto, 376-2147483647 - Nazaré, Salvador - BA, 40050-410, Brazil
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Av. Paulista, 1499 - Bela Vista, São Paulo - SP, 01310-200, Brazil
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Av. Nove de Julho, 5109 - 8° andar - Itaim Bibi, São Paulo - SP, 01406-200, Brazil
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Av. Brg. Faria Lima, 5416 - Vila Sao Pedro, São José do Rio Preto - SP, 15090-000, Brazil
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Av. Mal. Campos, 1133-2147483647 - Santa Cecilia, Vitória - ES, 29043-260, Brazil
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GD01, TRW Building, 3280 Hospital Dr NW, Calgary, AB T2N 4Z6, Canada
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3755 Chem. de la Côte-Sainte-Catherine, Montréal, QC H3T 1E2, Canada
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Av. Apoquindo 2827, piso 12, Las Condes, Región Metropolitana, Chile
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Santiago, Santiago Metropolitan Region, Chile
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Francisco Salazar 1145, Temuco, Araucanía, Chile
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146 Rue Léo Saignat 11, 33076 Bordeaux, France
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Toulouse, France
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Hamburg, Germany
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Feodor-Lynen-Straße 15, 30625 Hannover, Germany
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Max-Lebsche-Platz 31, 81377 München, Germany
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Schleichstraße 6, 72076 Tübingen, Germany
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Prittwitzstraße 10/C26, 89075 Ulm, Germany
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9/F & 10/F, Department of Economics, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong, Ma Liu Shui, Hong Kong
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SSKM Hospital Rd, Bhowanipore, Kolkata, West Bengal 700020, India
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J Merwanji St, Parel East, Parel, Mumbai, Maharashtra 400012, India
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No 30, Gangapur Rd, Balwant Nagar, Satpur Colony, Nashik, Maharashtra 422002, India
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Jerusalem, Israel
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Jerusalem, Israel
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Petah Tikva, Israel
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Tel Aviv University, Ramat Aviv, Tel Aviv-Yafo, 6997801, Israel
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52100 Arezzo, Province of Arezzo, Italy
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Via Roma, 64, 83100 Avellino AV, Italy
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Largo Ignazio Ciaia, 13, 70125 Bari BA, Italy
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47014 Meldola, Province of Forlì-Cesena, Italy
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Via Olgettina, 58, 20132 Milano MI, Italy
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Via Giuseppe Orus, 2, 35131 Padova PD, Italy
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Via Lecce, 73039 Tricase LE, Italy
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Via S. Giovanni Lupatoto, 24, 37134 Verona VR, Italy
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Daejeon, South Korea
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Goyang-si, Gyeonggi-do, South Korea
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Incheon, South Korea
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Meibergdreef 9, 1105 AZ Amsterdam, Netherlands
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Mesdaglaan 85, 6813 GN Arnhem, Netherlands
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Poznańska 3, 60-848 Poznań, Poland
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al. Jana Pawła II 61/212, 01-031 Warszawa, Poland
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Str. Clinicilor 5-7, Cluj-Napoca 400006, Romania
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Bulevardul Mamaia 300, Constanța, Romania
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Craiova, Romania
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Yekaterinburg, Sverdlovsk Oblast, Russia, 620102
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Kuzmolovsky, Leningrad Oblast, Russia, 188663
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Kashira Hwy, 23, Moskva, Russia, 115478
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Vysokovol'tnaya Ulitsa, 9, Ryazan', Ryazanskaya oblast', Russia, 390026
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University Embankment, 7-9, Sankt-Peterburg, Russia, 199034
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Carrer de la Diputació, 180, 08011 Barcelona, Spain
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Hospital Universitario Reina Sofía, Edificio IMIBIC, Av. Menéndez Pidal, s/n, 14004 Córdoba, Spain
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15006 A Coruña, Spain
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C. Comandante Benítez, 3, 28045 Madrid, Spain
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Arquitecto Francisco Peñalosa, 18, 29010 Málaga, Spain
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Av. de Pío XII, 55, 31008 Pamplona, Navarra, Spain
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Parc del Taulí, 1 Edifici Santa Fe, ala, izquierda, planta 2, 08208 Sabadell, Barcelona, Spain
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C. Brasil, 3, 41013 Sevilla, Spain
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Avenida Fernando Abril Martorell, Torre 106 A 7planta, 46026 València, Valencia, Spain
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Kaohsiung City, Taiwan
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Dörtler, 01120 Seyhan/Adana, Turkey
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Edirne, Edirne Merkez/Edirne, Turkey
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İstanbul, Turkey
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İzmir, Turkey
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Yamanlar, 35575 Karşıyaka/İzmir, Turkey
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Chernivtsi, Chernivtsi Oblast, Ukraine, 58000
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Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76000
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Poltava, Poltava Oblast, Ukraine, 36000
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Zaporizhzhia, Zaporizhia Oblast, Ukraine, 69061
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Zaporizhzhia, Zaporizhia Oblast, Ukraine, 69061
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Leicester Royal Infirmary, Knighton St, Leicester LE1 5WW, UK
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99 Brookline Ave, Boston, MA 02215, USA
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1250 1st Ave., New York, NY 10065, USA
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Florida 8000 (Camino La Carrindanga km 7,5), Bahía Blanca, Provincia de Buenos Aires, Argentina
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QUADRA SCN QUADRA 1 BLOCO F SALA 1606 EDIFICIO AMERICA OFFICE TOWER - Asa Norte, Brasília - DF, 70711-905, Brazil
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R. Cel. Pedro Benedet, 420-2147483646 - Pio Corrêa, Criciúma - SC, 88811-508, Brazil
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R. Francisco Holanda, 285 A - Dionísio Torres, Fortaleza - CE, 60135-215, Brazil
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R. Itororó, 211 - sala 307 - Menino Deus, Porto Alegre - RS, 90110-290, Brazil
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Rio de Janeiro, State of Rio de Janeiro, Brazil
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Av. Paulista, 1499 - Bela Vista, São Paulo - SP, 01310-200, Brazil
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2, Andree Rd, Bheemanna Garden, Shanti Nagar, Bengaluru, Karnataka 560027, India
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Doddavokalgeri, k.t.street, Tilak Nagar, Mysuru, Karnataka 570001, India
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Tulum 192 Manzana 17, capilla ecumenica, Supermanzana 4, 77500 Benito Juárez, Q.R., Mexico
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C. Sor Juana I. de La C. 103, 5 de Mayo, 50090 Toluca de Lerdo, Méx., Mexico
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3045 PM Rotterdam, Netherlands
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Michała Bobrzyńskiego 14, 30-348 Kraków, Poland
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Baia Mare, Romania
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No. 48, Cluj-Napoca 400015, Romania
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Iași, Romania
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Arkhangelsk, Arkhangelsk Oblast, Russia, 163045
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Akademgorodok St, 50/28, Krasnoyarsk, Krasnoyarskiy kray, Russia, 660036
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Ulitsa Karla Marksa, 62, Kursk, Kurskaya oblast', Russia, 305029
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Moscow, Russia
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Omsk Oblast, Russia, 644013
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Октябрьская наб., 44, Sankt-Peterburg, Russia, 193230
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Leninskiy Ave, 151, Sankt-Peterburg, Russia, 196247
National Cancer Centre Singapore
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Edifici Collserola Hospital Universitari Vall d'Hebron, Passeig de la Vall d'Hebron, 129, 08035 Barcelona, Spain
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C. de Nuria, 57. 1ª, Planta, 28034 Madrid, Spain
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Av. de Gregorio del Amo, 8, 28040 Madrid, Spain
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Ctra. de Pozuelo, 28, 28222 Majadahonda, Madrid, Spain
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No. 1650號, Section 4, Taiwan Blvd, Xitun District, Taichung City, Taiwan 40705
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No:, Asmalı Mescit, Meşrutiyet Cd. No:47, 34430 Beyoğlu/İstanbul, Turkey
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İstanbul, Turkey
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Dnipro, Dnipropetrovsk Oblast, Ukraine, 49000
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Kharkiv, Kharkiv Oblast, Ukraine
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Kyiv, Ukraine, 02000
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Emmanuel Kaye Building, Manresa Rd, London SW3 6LR, UK
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Columbia, MD, USA
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Changsha, China, 410011
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China, 400030
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Harbin, Heilongjiang, China
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Jinan, China, 250012
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Donghu District, Nanchang, China, 330000
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Nanjing, China, 210029
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China, 200032
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Shenyang, China, 110042
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Xi'An, China, 710061
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Jinshui District, Zhengzhou, China, 450008
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