Spots Global Cancer Trial Database for Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma
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Trial Identification
Brief Title: Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma
Official Title: A Multicenter, Open Label, Randomized Phase II Trial of the MEK Inhibitor Pimasertib or Dacarbazine in Previously Untreated Subjects With N-Ras Mutated Locally Advanced or Metastatic Malignant Cutaneous Melanoma
Study ID: NCT01693068
Study Description
Brief Summary: This is a Phase 2, multicenter, randomized, controlled, open-label trial of pimasertib versus dacarbazine aimed to confirm the activity of pimasertib in previously untreated subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma by comparing the progression-free survival (PFS) of subjects treated with either pimasertib or dacarbazine and by getting a better understanding of the efficacy, safety, pharmacogenomics (PGx) and their relationship with pimasertib exposure.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Birmingham, Alabama, United States
Research Site, Tucson, Arizona, United States
Research Site, San Francisco, California, United States
Research Site, Miami Beach, Florida, United States
Research Site, Orlando, Florida, United States
Research Site, Maywood, Illinois, United States
Research Site, Indianapolis, Indiana, United States
Research Site, Boston, Massachusetts, United States
Please contact the US Medical Information in, Rockland, Massachusetts, United States
Research Site, Saint Louis, Missouri, United States
Research Site, Morristown, New Jersey, United States
Research Site, New York, New York, United States
Research Site, Columbus, Ohio, United States
Research Site, Dallas, Texas, United States
Research Site, Madison, Wisconsin, United States
Research Site, Adelaide, SA, , Australia
Research Site, Albury/Wodonga, , Australia
Research Site, Auchenflower, , Australia
Research Site, Box Hill, , Australia
Research Site, Greenslopes, , Australia
Research Site, Herston, , Australia
Research Site, Malvern, , Australia
Research Site, North Sydney, , Australia
Research Site, Prahran, , Australia
Research Site, Wendouree, , Australia
Research Site, Woodville South, , Australia
Research site, Woolloongabba, , Australia
Research Site, Brussel, , Belgium
Research Site, Bruxelles, , Belgium
Research Site, Edegem, , Belgium
Research Site, Bordeaux, , France
Research Site, Brest, , France
Research Site, Dijon, , France
Research Site, Lille, , France
Research Site, Lyon, , France
Research Site, Marseille, , France
Research Site, Montpellier, , France
Research Site, Nantes, , France
Research Site, Paris, , France
Research Site, Pierre Benite, , France
Research Site, Rennes, , France
Research Site, Toulouse, , France
Research Site, Villejuif, , France
Research Site, Augsburg, , Germany
Research Site, Berlin, , Germany
Research Site, Bonn, , Germany
Research Site, Buxtehude, , Germany
Research site, Düsseldorf, , Germany
Research Site, Erlangen, , Germany
Research Site, Essen, , Germany
Research Site, Frankfurt am Main, , Germany
Research Site, Hamburg, , Germany
Research Site, Hannover, , Germany
Research Site, Kiel, , Germany
Research Site, Köln, , Germany
Research Site, Leipzig, , Germany
Research Site, Magdeburg, , Germany
Research Site, Mainz, , Germany
Research site, München, , Germany
Research Site, Münster, , Germany
Research Site, Plauen, , Germany
Research Site, Tübingen, , Germany
Research Site, Würzburg, , Germany
Research Site, Jerusalem, , Israel
Research Site, Ramat-Gan, , Israel
Research Site, Tel-Aviv, , Israel
Research Site, Bari, , Italy
Research Site, Genova, , Italy
Research Site, Meldola - FC, , Italy
Research Site, Milano, , Italy
Research Site, Napoli, , Italy
Research Site, Padova, , Italy
Research Site, Roma, , Italy
Research Site, Siena, , Italy
Research Site, Groningen, , Netherlands
Research Site, Rotterdam, , Netherlands
Research Site, Utrecht, , Netherlands
Research Site, Christchurch, , New Zealand
Research Site, Hamilton, , New Zealand
Research Site, Palmerston North, , New Zealand
Research Site, Tauranga, , New Zealand
Research Site, Durban, , South Africa
Research Site, Johannesburg, , South Africa
Research Site, Pietermaritzburg, , South Africa
Research Site, Pretoria, , South Africa
Research Site, Badalona, , Spain
Research Site, Barcelona, , Spain
Research Site, l'Hospitalet de Llobregat, , Spain
Research Site, Madrid, , Spain
Research Site, Majadahonda, , Spain
Research Site, Málaga, , Spain
Research Site, Pamplona, , Spain
Research Site, Sevilla, , Spain
Research Site, Göteborg, , Sweden
Research Site, Stockholm, , Sweden
Research Site, Basel, , Switzerland
Research Site, Zürich, , Switzerland
Research Site, Cambridge, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Newcastle upon Tyne, , United Kingdom
Research Site, Southampton, , United Kingdom
Contact Details
Name: Study Director
Affiliation: EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR
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