CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy

NCT00257205 | Completed Phase 3 DMC

• 1 other identifier: A3671009
• Study Type: interventional
• Target: 655
• Locations: 20 countries
• Sites: 137

Brief Summary

This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• overall survival

  August 2010

Secondary Outcomes (9)

• adverse events

  1 year

• PFS at 6 months

  6 months

• objective tumor response

  1 year

• Durable response

  6 months

• pharmacokinetics endpoints

  15 months

Study Arms (2)

B

ACTIVE COMPARATOR

Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)

Drug: dacarbazine; Drug: temozolomide

A

EXPERIMENTAL

Drug: CP-675,206

Interventions

dacarbazine DRUG

decarbazine 1000 mg/m2 IV Q 21 days x 12

B

CP-675,206 DRUG

CP-675,206 15 mg/kg IV Q 90 days x 4

Also known as: anti-CTLA4 human monoclonal antibody

A

temozolomide DRUG

temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions.
• Serum lactic acid dehydrogenase (LDH) \<= 2 x ULN
• ECOG performance status of 0 or 1

You may not qualify if:

• Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma.
• History of brain metastases

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (143)

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Huntsville, Alabama, 35805, United States

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Mobile, Alabama, 36607, United States

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Scottsdale, Arizona, 85260, United States

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Little Rock, Arkansas, 72205, United States

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Bakersfield, California, 93309, United States

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Corona, California, 92879, United States

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Fullerton, California, 92835, United States

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Glendora, California, 91741, United States

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Huntington Beach, California, 92648, United States

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Long Beach, California, 90813, United States

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Los Alamitos, California, 90720, United States

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Los Angeles, California, 90095-6970, United States

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Los Angeles, California, 90095, United States

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Oxnard, California, 93030, United States

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Pasadena, California, 91105, United States

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Pomona, California, 91767, United States

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Rancho Cucamonga, California, 91730, United States

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Santa Barbara, California, 93105, United States

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Santa Maria, California, 93454, United States

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West Covina, California, 91790, United States

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Aurora, Colorado, 80045, United States

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Stamford, Connecticut, 06902-3628, United States

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Boynton Beach, Florida, 33426, United States

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Lake Worth, Florida, 33461-4710, United States

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Zion, Illinois, 60099, United States

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Beech Grove, Indiana, 46107, United States

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Indianapolis, Indiana, 46237, United States

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Indianapolis, Indiana, 46260, United States

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Baltimore, Maryland, 21237-3998, United States

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City of Saint Peters, Missouri, 63376, United States

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Creve Coeur, Missouri, 63141, United States

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St Louis, Missouri, 63110, United States

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Omaha, Nebraska, 68114, United States

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Henderson, Nevada, 89015, United States

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Henderson, Nevada, 89052, United States

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Las Vegas, Nevada, 89109, United States

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Las Vegas, Nevada, 89128, United States

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Las Vegas, Nevada, 89135, United States

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Las Vegas, Nevada, 89148, United States

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Morristown, New Jersey, 07962, United States

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Albany, New York, 12206, United States

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New York, New York, 10016, United States

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Chapel Hill, North Carolina, 27599-7600, United States

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Charlotte, North Carolina, 28203, United States

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Charlotte, North Carolina, 28204, United States

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Canton, Ohio, 44718, United States

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Columbus, Ohio, 43210, United States

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Dover, Ohio, 44718, United States

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Bethlehem, Pennsylvania, 18015, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Dallas, Texas, 75246, United States

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Salt Lake City, Utah, 84112, United States

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Federal Way, Washington, 98003, United States

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Lakewood, Washington, 98499, United States

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Tacoma, Washington, 98405, United States

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Ciudad de Buenos Aires, Buenos Aires, C1280AEA, Argentina

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Waratah, New South Wales, 2300, Australia

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Westmead, New South Wales, 2145, Australia

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Woolloongabba, Queensland, 4102, Australia

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Adelaide, South Australia, 5000, Australia

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Launceston, Tasmania, 7250, Australia

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East Melbourne, Victoria, 3002, Australia

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Vienna, A-1090, Austria

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Brussels, 1090, Belgium

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Leuven, 3000, Belgium

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Namur, 5000, Belgium

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Roeselare, 8800, Belgium

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Turnhout, 2300, Belgium

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Wilrijk, 2610, Belgium

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Yvoir, 5530, Belgium

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Calgary, Alberta, T2N 4N2, Canada

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Edmonton, Alberta, T6G 1Z2, Canada

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Vancouver, British Columbia, V5Z 4E6, Canada

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Victoria, British Columbia, V8R 6V5, Canada

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Winnipeg, Manitoba, R3E 0V9, Canada

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Hamilton, Ontario, L8V 5C2, Canada

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London, Ontario, N6A 4L6, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Windsor, Ontario, N8W 1L9, Canada

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Windsor, Ontario, N8W 2X3, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Québec, Quebec, G1R 2J6, Canada

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Montpellier, Cedex 05, 34280, France

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Besançon, 25030, France

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Bordeaux, 33075, France

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Boulogne, 92104, France

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Caen, 14033, France

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Lille, 59000, France

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Marseille, 13009, France

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Nantes, 44035, France

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Paris, 75010, France

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Berlin, 10117, Germany

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Frankfurt, 60488, Germany

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Hanover, 30449, Germany

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Kiel, 24105, Germany

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Tübingen, 72076, Germany

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Athens, 115 27, Greece

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Jerusalem, 91120, Israel

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Tel Aviv, 64239, Israel

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Tel Litwinsky, 52621, Israel

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Genova, 16132, Italy

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Milan, 20141, Italy

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Napoli, 80131, Italy

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Padua, 35128, Italy

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Roma, 00144, Italy

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Siena, 53100, Italy

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Mexico City, Mexico City, 06720, Mexico

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Mexico City, Mexico City, 14080, Mexico

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Amsterdam, North Holland, 1066 CX, Netherlands

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Groningen, Provincie Groningen, 9713 GZ, Netherlands

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Leiden, South Holland, 2311 JS, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Bialystok, 15-027, Poland

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Krakow, 31-115, Poland

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Lubin, 59-300, Poland

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Poznan, 61-866, Poland

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Warsaw, 02-781, Poland

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Obninsk, Kaluga Oblast, 249036, Russia

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Moscow, 115478, Russia

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Saint Petersburg, 197758, Russia

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Bratislava, 833 10, Slovakia

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Cape Town, 7500, South Africa

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Pretoria, 0181, South Africa

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Palma de Mallorca, Balearic Islands, 07014, Spain

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Barcelona, Barcelona, 08036, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Santander, Cantabria, 39008, Spain

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Madrid, Madrid, 28041, Spain

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Pamplona, Navarre, 31008, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Gothenburg, 413 45, Sweden

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Lund, 221 85, Sweden

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Zurich, 8091, Switzerland

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Truro, Cornwall, TR1 3LJ, United Kingdom

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Northwood, Middlesex, HA6 2RN, United Kingdom

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Sutton, Surrey, SM2 5PT, United Kingdom

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London, SW3 6JJ, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Newcastle upon Tyne, NE4 6BE, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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Wolverhampton, WV10 0QP, United Kingdom

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Related Publications (2)

• Friedlander P, Wood K, Wassmann K, Christenfeld AM, Bhardwaj N, Oh WK. A whole-blood RNA transcript-based gene signature is associated with the development of CTLA-4 blockade-related diarrhea in patients with advanced melanoma treated with the checkpoint inhibitor tremelimumab. J Immunother Cancer. 2018 Sep 18;6(1):90. doi: 10.1186/s40425-018-0408-9.

  PMID: 30227886 DERIVED

• Ribas A, Kefford R, Marshall MA, Punt CJ, Haanen JB, Marmol M, Garbe C, Gogas H, Schachter J, Linette G, Lorigan P, Kendra KL, Maio M, Trefzer U, Smylie M, McArthur GA, Dreno B, Nathan PD, Mackiewicz J, Kirkwood JM, Gomez-Navarro J, Huang B, Pavlov D, Hauschild A. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma. J Clin Oncol. 2013 Feb 10;31(5):616-22. doi: 10.1200/JCO.2012.44.6112. Epub 2013 Jan 7.

  PMID: 23295794 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Dacarbazine; tremelimumab; Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2005
• First Posted: November 22, 2005
• Study Start: March 1, 2006
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

CH (1); IL (3); ME (2); AU (1); NL (4); FR (9); US (55); GB (8); RU (3); SE (2); GR (1); DE (5); SL (1); CA (13); AR (1); PL (5); ZA (2); ES (8); IT (6); BE (7)