Spots Global Cancer Trial Database for Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)
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Trial Identification
Brief Title: Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)
Official Title: Randomized, Open Label, Multicenter Phase III Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 Tablets Versus Best Available Care (The RESPONSE Trial)
Study ID: NCT01243944
Conditions
Study Description
Brief Summary: This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Birmingham, Alabama, United States
, Scottsdale, Arizona, United States
, Pomona, California, United States
, Sacramento, California, United States
, San Diego, California, United States
, Bridgeport, Connecticut, United States
, New Haven, Connecticut, United States
, Boynton Beach, Florida, United States
, Fort Myers, Florida, United States
, Jacksonville, Florida, United States
, Winter Park, Florida, United States
, Boise, Idaho, United States
, Chicago, Illinois, United States
, Lafayette, Louisiana, United States
, Scarborough, Maine, United States
, Baltimore, Maryland, United States
, Columbia, Maryland, United States
, Southfield, Michigan, United States
, Jefferson City, Missouri, United States
, Saint Louis, Missouri, United States
, Omaha, Nebraska, United States
, Morristown, New Jersey, United States
, Somerville, New Jersey, United States
, Charleston, South Carolina, United States
, Greenville, South Carolina, United States
, Nashville, Tennessee, United States
, Houston, Texas, United States
, Seattle, Washington, United States
, Buenos Aires, , Argentina
, Brisbane, , Australia
, Parkville, , Australia
, Tweed Heads, , Australia
, Antwerp, , Belgium
, Brugge, , Belgium
, Bruxelles, , Belgium
, Leuven, , Belgium
, Hamilton, , Canada
, Montreal, , Canada
, Toronto, , Canada
, Beijing, , China
, Hangzhou, , China
, Avignon, , France
, Bayonne, , France
, Brest, , France
, Lille, , France
, Nantes, , France
, Paris, , France
, Vandœuvre-lès-Nancy, , France
, Aachen, , Germany
, Berlin, , Germany
, Bonn, , Germany
, Freiburg, , Germany
, Hamburg, , Germany
, Jena, , Germany
, Magdeburg, , Germany
, Mannheim, , Germany
, Minden, , Germany
, Munchen, , Germany
, Ulm, , Germany
, Budapest, , Hungary
, Kecskemet, , Hungary
, Szeged, , Hungary
, Szombathely, , Hungary
, Bari, , Italy
, Bergamo, , Italy
, Bologna, , Italy
, Firenze, , Italy
, Milano, , Italy
, Napoli, , Italy
, Orbassano, , Italy
, Pavia, , Italy
, Reggio Calabria, , Italy
, Roma, , Italy
, Varese, , Italy
, Vicenza, , Italy
, Chiba, , Japan
, Chuo-city Yamanashi, , Japan
, Maebashi, , Japan
, Nagoya-city Aichi, , Japan
, Osaka, , Japan
, Tokyo, , Japan
, Seoul, , Korea, Republic of
, Enschede, , Netherlands
, Rotterdam, , Netherlands
, Moscow, , Russian Federation
, St. Petersburg, , Russian Federation
, Barcelona, , Spain
, Coruña, , Spain
, Las Palmas de Gran Canaria, , Spain
, Madrid, , Spain
, Majadahonda, , Spain
, Malaga, , Spain
, Pamplona, , Spain
, Salamanca, , Spain
, Valencia, , Spain
, Bangkok, , Thailand
, Ankara, , Turkey
, Istanbul, , Turkey
, Izmir, , Turkey
, Bournemouth, , United Kingdom
, Cardiff, , United Kingdom
, London, , United Kingdom
Contact Details
Name: Srdan Verstovsek, MD,PhD
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_DIRECTOR
Name: Mark Jones, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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