Melanoma Clinical Trial

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

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)

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

655

Study ID:

NCT00257205

Recruitment Status:

Completed

Sponsor:

AstraZeneca

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There are 139 Locations for this study

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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, 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, United States
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Boynton Beach Florida, 33426, United States
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Lake Worth Florida, 33461, 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, 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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St. Louis Missouri, 63110, United States
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St. Peters Missouri, 63376, 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, 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, C1280, 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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Wien , A-109, Austria
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Brussel , 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 4, Canada
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Edmonton Alberta, T6G 1, Canada
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Vancouver British Columbia, V5Z 4, Canada
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Victoria British Columbia, V8R 6, Canada
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Winnipeg Manitoba, R3E 0, Canada
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Hamilton Ontario, L8V 5, Canada
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London Ontario, N6A 4, Canada
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Toronto Ontario, M4N 3, Canada
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Toronto Ontario, M5G 2, Canada
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Windsor Ontario, N8W 1, Canada
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Windsor Ontario, N8W 2, Canada
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Montreal Quebec, H2L 4, Canada
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Quebec , G1R 2, Canada
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Montpellier Cedex 05, 34280, France
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Besancon , 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 Cedex 1 , 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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Hannover , 30449, Germany
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Kiel , 24105, Germany
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Tuebingen , 72076, Germany
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Athens , 115 2, Greece
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Jerusalem , 91120, Israel
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Tel Aviv , 64239, Israel
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Tel Hashomer , 52621, Israel
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Genova , 16132, Italy
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Milano , 20141, Italy
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Napoli , 80131, Italy
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Padova , 35128, Italy
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Roma , 00144, Italy
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Siena , 53100, Italy
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Mexico DF, 06720, Mexico
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Mexico DF, 14080, Mexico
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Groningen GR, 9713 , Netherlands
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Amsterdam NH, 1066 , Netherlands
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Leiden ZH, 2311 , Netherlands
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Nijmegen , 6525 , Netherlands
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Bialystok , 15-02, Poland
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Krakow , 31-11, Poland
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Lubin , 59-30, Poland
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Poznan , 61-86, Poland
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Warszawa , 02-78, Poland
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Obninsk Kaluga Region, 24903, Russian Federation
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Moscow , 11547, Russian Federation
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St. Petersburg , 19775, Russian Federation
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Bratislava , 833 1, Slovakia
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Cape Town , 7500, South Africa
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Pretoria , 0181, South Africa
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Oviedo Asturias, 33006, Spain
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Hospitalet de Llobregat Barcelona, 08907, Spain
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Santander Cantabria, 39008, Spain
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Palma de Mallorca Islas Baleares, 07014, Spain
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Pamplona Navarra, 31008, Spain
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Barcelona , 08036, Spain
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Madrid , 28041, Spain
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Zaragoza , 50009, Spain
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Goteborg , 413 4, Sweden
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Lund , 221 8, Sweden
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Zurich , 8091, Switzerland
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Truro Cornwall, TR1 3, United Kingdom
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Northwood Middlesex, HA6 2, United Kingdom
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Sutton Surrey, SM2 5, United Kingdom
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London , SW3 6, United Kingdom
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Manchester , M20 4, United Kingdom
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Newcastle upon Tyne , NE4 6, United Kingdom
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Newcastle Upon Tyne , NE7 7, United Kingdom
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Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

655

Study ID:

NCT00257205

Recruitment Status:

Completed

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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