Spots Global Cancer Trial Database for Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Placebo Plus Erlotinib in Patients With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy
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Trial Identification
Brief Title: Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Placebo Plus Erlotinib in Patients With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy
Official Title: A Randomized, Double-Blind, Placebo-controlled Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Erlotinib Plus Placebo in Patients With Nonprogression Following Four Cycles of 1st-line Platinum-based Chemotherapy for Advanced NSCLC
Study ID: NCT01186861
Study Description
Brief Summary: A multicenter, randomized, double-blind, placebo-controlled, phase 2 study with a 1:1 randomization scheme.
Detailed Description: Adult patients with advanced Non-small Cell Lung Cancer (NSCLC) and nonprogression after platinum-based chemotherapy will be randomized 1:1 to receive either OSI-906 plus erlotinib or placebo plus erlotinib.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Site US10007, Jacksonville, Florida, United States
Site US10001, Port Saint Lucie, Florida, United States
Site US10002, Albany, Georgia, United States
Site US10008, Chicago, Illinois, United States
Site US10011, Scarborough, Maine, United States
Site US10004, Greensboro, North Carolina, United States
Site US10010, Winston-Salem, North Carolina, United States
Site BR55005, Barretos, , Brazil
Site BR55004, Brasilia, , Brazil
Site BR55015, Cachoeiro de Itapemirim, , Brazil
Site BR55011, Florianopolis, , Brazil
Site BR55003, Fortaleza, , Brazil
Site BR55016, Goiania, , Brazil
Site BR55006, Ijui, , Brazil
Site BR55001, Itajai, , Brazil
Site BR55008, Piracicaba, , Brazil
Site BR55013, Porto Alegre, , Brazil
Site BR55014, Porto Alegre, , Brazil
Site BR55012, Ribeirao Preto, , Brazil
Site BR55002, Rio de Janeiro, , Brazil
Site BR55007, Sao Paulo, , Brazil
Site CA11001, Oshawa, , Canada
Site CA11004, Ottawa, , Canada
Site CA11006, Toronto, , Canada
Site CA11002, Toronto, , Canada
Site DE49014, Berlin, , Germany
Site DE49011, Dortmund, , Germany
Site DE49003, Grosshansdorf, , Germany
Site DE49001, Heidelberg, , Germany
Site DE49002, Hemer, , Germany
Site DE49009, Homburg/Saar, , Germany
Site DE49006, Immenhausen, , Germany
Site DE49012, Karlsruhe, , Germany
Site DE49015, Kassel, , Germany
Site DE49008, Koln, , Germany
Site DE49010, Lubeck, , Germany
Site DE49013, Mainz, , Germany
Site DE49005, Minden, , Germany
Site KR82007, Busan, , Korea, Republic of
Site KR82006, Hwasun, , Korea, Republic of
Site KR82008, Incheon, , Korea, Republic of
Site KR82004, Seongnam-si, , Korea, Republic of
Site KR82003, Seoul, , Korea, Republic of
Site KR82005, Seoul, , Korea, Republic of
Site KR82002, Seoul, , Korea, Republic of
Site KR82001, Suwon, , Korea, Republic of
Site PL48002, Elblag, , Poland
Site PL48005, Szczecin, , Poland
Site PL48008, Torun, , Poland
Site PL48006, Wroclaw, , Poland
Site RO40005, Alba Iulia, , Romania
Site RO40001, Baia Mare, , Romania
Site RO40007, Brasov, , Romania
Site RO40002, Cluj-Napoca, , Romania
Site RO40003, Cluj-Napoca, , Romania
Site RO40006, Craiova, , Romania
Site RO40004, Hunedoara, , Romania
Site RU70002, Chelaybinsk, , Russian Federation
Site RU70010, Kazan, , Russian Federation
Site RU70007, Saint Petersburg, , Russian Federation
Site RU70009, Saint Petersburg, , Russian Federation
Site RU70011, Saint Petersburg, , Russian Federation
Site GB44007, Bristol, , United Kingdom
Site GB44006, Dundee, , United Kingdom
Site GB44003, Leeds, , United Kingdom
Site GB44002, Leicester, , United Kingdom
Site GB44005, London, , United Kingdom
Site GB44001, Manchester, , United Kingdom
Site GB44004, Southampton, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Astellas Pharma Global Development
Role: STUDY_DIRECTOR
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