CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy
NCT ID: NCT00257205
Last Updated: 2012-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
655 participants
INTERVENTIONAL
2006-03-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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B
Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)
dacarbazine
decarbazine 1000 mg/m2 IV Q 21 days x 12
temozolomide
temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12
A
CP-675,206
CP-675,206 15 mg/kg IV Q 90 days x 4
Interventions
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dacarbazine
decarbazine 1000 mg/m2 IV Q 21 days x 12
CP-675,206
CP-675,206 15 mg/kg IV Q 90 days x 4
temozolomide
temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Serum lactic acid dehydrogenase (LDH) \<= 2 x ULN
* ECOG performance status of 0 or 1
Exclusion Criteria
* History of brain metastases
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Bakersfield, California, United States
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Corona, California, United States
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Fullerton, California, United States
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Glendora, California, United States
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Huntington Beach, California, United States
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Long Beach, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Oxnard, California, United States
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Pasadena, California, United States
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Pomona, California, United States
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Rancho Cucamonga, California, United States
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Santa Barbara, California, United States
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Santa Maria, California, United States
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West Covina, California, United States
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Aurora, Colorado, United States
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Stamford, Connecticut, United States
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Boynton Beach, Florida, United States
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Lake Worth, Florida, United States
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Zion, Illinois, United States
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Beech Grove, Indiana, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Baltimore, Maryland, United States
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City of Saint Peters, Missouri, United States
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Creve Coeur, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Morristown, New Jersey, United States
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Albany, New York, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Canton, Ohio, United States
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Columbus, Ohio, United States
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Dover, Ohio, United States
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Bethlehem, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Dallas, Texas, United States
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Salt Lake City, Utah, United States
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Federal Way, Washington, United States
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Lakewood, Washington, United States
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Tacoma, Washington, United States
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Ciudad de Buenos Aires, Buenos Aires, Argentina
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Waratah, New South Wales, Australia
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Westmead, New South Wales, Australia
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Woolloongabba, Queensland, Australia
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Adelaide, South Australia, Australia
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Launceston, Tasmania, Australia
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East Melbourne, Victoria, Australia
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Vienna, , Austria
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Brussels, , Belgium
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Leuven, , Belgium
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Namur, , Belgium
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Roeselare, , Belgium
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Turnhout, , Belgium
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Wilrijk, , Belgium
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Yvoir, , Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Montpellier, Cedex 05, France
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Besançon, , France
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Bordeaux, , France
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Boulogne, , France
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Caen, , France
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Lille, , France
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Marseille, , France
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Nantes, , France
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Paris, , France
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Berlin, , Germany
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Frankfurt, , Germany
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Hanover, , Germany
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Kiel, , Germany
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Tübingen, , Germany
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Athens, , Greece
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Jerusalem, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Genova, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Roma, , Italy
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Siena, , Italy
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Amsterdam, North Holland, Netherlands
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Groningen, Provincie Groningen, Netherlands
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Leiden, South Holland, Netherlands
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Nijmegen, , Netherlands
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Bialystok, , Poland
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Krakow, , Poland
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Lubin, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Obninsk, Kaluga Oblast, Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Bratislava, , Slovakia
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Cape Town, , South Africa
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Pretoria, , South Africa
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Palma de Mallorca, Balearic Islands, Spain
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Barcelona, Barcelona, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Santander, Cantabria, Spain
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Madrid, Madrid, Spain
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Pamplona, Navarre, Spain
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Oviedo, Principality of Asturias, Spain
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Zaragoza, Zaragoza, Spain
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Gothenburg, , Sweden
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Lund, , Sweden
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Zurich, , Switzerland
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Truro, Cornwall, United Kingdom
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Northwood, Middlesex, United Kingdom
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Sutton, Surrey, United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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A3671009
Identifier Type: -
Identifier Source: org_study_id
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