Trial Synopsis

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
Status: Completed
Study Phase: Phase 2
Start Date: December 2010 | Completion Date: March 2015
Condition(s): Non-Small Cell Lung Cancer (NSCLC) With Nonprogression Following 4
Cycles of Platinum-based Chemotherapy
Full Title of Study
A Randomized, Double-Blind, Placebo-controlled Phase 2 Study of Maintenance OSI906 Plus Erlotinib (Tarceva®), or Erlotinib Plus Placebo in Patients With
Nonprogression Following Four Cycles of 1st-line Platinum-based Chemotherapy for
Advanced NSCLC
Overview
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.
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver,
Investigator, Outcomes Assessor), Primary Purpose: Treatment
Investigator Details
Lead Sponsor: Astellas Pharma Inc
Study Director: Medical Director Astellas Pharma Global Development
Trial Location Details
Facility: 10007: Baptist Cancer Institute Jacksonville, United States
Facility: 10001: Hematology Oncology Associates of the Treasure Coast Port St. Lucie,
United States
Facility: 10002: Phoebe Putney Memorial Hospital Albany, United States
Facility: 10008: Rush Presbyterian-Saint Luke's Medical Center Chicago, United States
Facility: 10011: Maine Center for Cancer Medicine and Blood Disorders Scarborough,
United States
Facility: 10004: Moses H. Cone Regional Cancer Center Greensboro, United States
Facility: Site: 10010 Piedmont Hematlogy Oncology Associates, PLLC Winston - Salem,
United States
Facility: 55003: Centro Regional Integrado de Oncologia Fortaleza, Brazil
Facility: 55015: Centro de Pesquisa Clínica em Oncologia-CPCO Cachoeiro de Itapemirim,
Brazil
Facility: 55016:Centro Brasileiro de Radioterapia Oncologia e Mastologia Goiânia, Brazil
Facility: 55006: Hospital de Caridade de Ijuí Ijuí, Brazil
Facility: 55011: CEPON-Centro de pesquisas Oncologicas Porto Alegre, Brazil
Facility: 55013: Clínica de Oncologia de Porto Alegre Porto Alegre, Brazil
Facility: 55014: Hospital São Lucas - PUCRS Porto Alegre, Brazil
Facility: 55001: Clínica de Neoplasias Litoral Itajaí, Brazil
Facility: 55008: Irmandade da Santa Casa de Misericórdia de Piracicaba Piracicaba,
Brazil
Facility: 55005: Fundação Pio XII, Hospital de Câncer de Barretos Barretos, Brazil
Facility: 55012: Instituto Ribeirãopretano de Combate ao Câncer Ribeirão Preto, Brazil
Facility: 55004: Hospital Universitário de Brasília-HUB Brasilia, Brazil
Facility: 55002: Instituto Nacional do Câncer Rio de Janeiro, Brazil
Facility: 55007:Instituto do Câncer de São Paulo Octavio Frias de Oliveira São Paulo,
Brazil
Facility: 11001: RSM Durham Regional Cancer Centre Oshawa, Canada
Facility: 11004: Ottawa Regional Cancer Centre Ottawa, Canada
Facility: 11006: Mount Sinai Hospital Toronto, Canada
Facility: 11002: Saint Joseph Health Center Toronto, Canada
Facility: 49001: Thoraxklink Heidelberg Heidelberg, Germany
Facility: 49012: Saint Vincentius-Kliniken Karlsruhe Karlsruhe, Germany
Facility: 49006: Fachklinik für Lungenkrankheiten Immenhausen, Germany
Facility: 49015: Klinikum Kassel Kassel, Germany
Facility: 49011: Klinikum Dortmund gGmbH Dortmund, Germany
Facility: 49002: Lungenklinik Hemer Hemer, Germany
Facility: 49005: Johannes-Wesling-Klinikum Minden, Germany
Facility: 49013: Katholisches Klinikum Mainz, Sankt Hildegardis-Krankenhaus
Mainz, Germany
Facility: 49009: Universitätsklinikum des Saarlandes Homburg/Saar, Germany
Facility: 49003: Krankenhaus Großhansdorf Großhansdorf, Germany
Facility: 49010: Universitätsklinikum Schleswig-Holstein Lübeck, Germany
Facility: 49014: Charite Berlin Berlin, Germany
Facility: 49008: Kliniken der Stadt Köln gGmbH Koln, Germany
Facility: 82007: Dong-A University Medical Center Busan, Korea, Republic of
Facility: 82001: Saint Vincent Hospital Gyeonggi-Do, Korea, Republic of
Facility: 82006: Chonnam National University Hwasun Hospital Hwasun, Jeollanam-do, Korea,
Republic of
Facility: 82008: Inha University Hospital Incheon, Korea, Republic of
Facility: 82004: Seoul National University Bundang Hospital Seongnam, Korea, Republic of
Facility: 82003: Severance Hospital, Yonsei University Health System Seoul, Korea,
Republic of
Facility: 82005: Samsung Medical Center Seoul, Korea, Republic of
Facility: 82002: Seoul Saint Mary's Hospital Seoul, Korea, Republic of
Facility: 48006: Katedra I Klinika Chorob Pluc Slaskiej AM, Dept. of Pulmonology
Wroclaw, Poland
Facility: 48008:Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital
Dzieciecy Torun, Poland
Facility: 48002: SPZOZ, Wojewódzki Szpital Zespolony w Elblagu Elblag, Poland
Facility: 48005: Specjalistyczny Szpital im. Prof. Alfreda SokołowskiegoSzczecin, Poland
Facility: 40005: Spitalul Judetean Alba Iulia Alba Iulia, Romania
Facility: 40002: Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca, Romania
Facility: 40003: Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca, Romania
Facility: 40006: Oncolab SRL Craiova, Romania
Facility: 40001: Spitalul Judetean de Urgenta Baia Mare Baia Mare, Romania
Facility: 40007: Policlinica de Diagnostic Rapid Brasov, Romania
Facility: 40004: Spitalul Municipal "Dr. Alexandru Simionescu" Hunedoara Hunedoara,
Romania
Facility: 70010: Republican Clinical Oncologic Dispensary of Ministry of health of
Republic Tatarstan Kazan, Russian Federation
Facility: 70002: Regional Oncology Centre Chelaybinsk, Russian Federation
Facility: 70007: Leningrad Regional Clinical Hospital Saint Petersburg, Russian Federation
Facility: 70009: Saint-Petersburg State Medical University n.a. ac. I.P. Pavlov,
Dept. of Thoracal Oncology Saint-Petersburg, Russian Federation
Facility: 70011: Saint-Petersburg State Medical University n.a. ac. I.P. Pavlov,
Dept. of Thoracal Oncology Saint-Petersburg, Russian Federation
Facility: 44007: Bristol Haematology and Oncology Centre Bristol, United Kingdom
Facility: 44003: Saint James's University Hospital Leeds, United Kingdom
Facility: 44002: Leicester Royal Infirmary Leicester, United Kingdom
Facility: 44005: University College London London, United Kingdom
Facility: 44001: Christie Hospital NHS Foundation Trust Manchester, United Kingdom
Facility: 44004: Southampton General Hospital Southampton, United Kingdom
Facility: 44006: Ninewells Hospital Dundee, United Kingdom
Interventions
Drug: OSI-906
Tablet administered with food and with up to 200 mL of water
Drug: erlotinib
Tablet administered at least 2 hours after food with up to 200 mL of water
Drug: placebo
Tablet administered at least 2 hours after food with up to 200 mL of water
Information Source
ID Number: OSI-906-205
NCT Identifier: NCT01186861
Health Authority: Array
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT01186861
ClinicalTrials.gov processed this data on September 29, 2016
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