Spots Global Cancer Trial Database for Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without Pictilisib in Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer
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Trial Identification
Brief Title: Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without Pictilisib in Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer
Official Title: A Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without GDC-0941 in Patients With Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer
Study ID: NCT01493843
Conditions
Study Description
Brief Summary: This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and without pictilisib in particpants with previously untreated advanced or recurrent non-small cell lung cancer (NSCLC). Particpants will be randomized to receive 4 cycles of carboplatin (C)/paclitaxel (P) and either pictilisib or placebo, with (participants with non-squamous NSCLC) or without (participants with squamous NSCLC) bevacizumab (B). Anticipated time on study treatment is until disease progression or intolerable toxicity occurs. Participants in placebo arms with disease progression may cross over to open-label active pictilisib.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alabama Oncology, Birmingham, Alabama, United States
Highlands Oncology Group, Rogers, Arkansas, United States
cCare, Encinitas, California, United States
Kaiser Permanente - Oakland, Oakland, California, United States
Desert Hematology Oncology Group, Rancho Mirage, California, United States
Kaiser Permanente - Roseville, Roseville, California, United States
Kaiser Permanente Sacramento Medical Center, Sacramento, California, United States
Southern CA Permanente Med Grp, San Diego, California, United States
Kaiser Permanente, San Francisco, California, United States
K. Permanente - Santa Clara, Santa Clara, California, United States
Stockton Hema Onc Med Grp Inc, Stockton, California, United States
Kaiser Permanente - Vallejo, Vallejo, California, United States
K. Permanente - Walnut Creek, Walnut Creek, California, United States
Hematology Oncology PC; Bennett Cancer Center, Stamford, Connecticut, United States
Lynn Regional Cancer Center West, Boca Raton, Florida, United States
Florida Cancer Specialists - Fort Myers (Colonial Center Dr), Fort Myers, Florida, United States
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy), Jacksonville, Florida, United States
Advanced Medical Specialties, Miami, Florida, United States
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building), Saint Petersburg, Florida, United States
University Cancer & Blood Center, LLC, Athens, Georgia, United States
Peachtree Hematology & Oncology Consultants, Pc, Atlanta, Georgia, United States
Georgia Cancer Specialists, Atlanta, Georgia, United States
Hematology-Oncology of Indiana, Pc, Indianapolis, Indiana, United States
Franklin Square Hospital, Baltimore, Maryland, United States
Massachusetts General Hospital., Boston, Massachusetts, United States
Dana Farber Cancer Inst., Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Wayne State University; Hemat/Onc, 4HW CRC, Detroit, Michigan, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Va Sierra Nevada Health Care System, Reno, Nevada, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
Roswell Park Cancer Inst., Buffalo, New York, United States
Piedmont Hematology Oncology Associates, Winston-Salem, North Carolina, United States
Gabrail Cancer Center, Canton, Ohio, United States
The Christ Hospital, Cincinnati, Ohio, United States
Univ Hosp Case Medical Center, Cleveland, Ohio, United States
Center for Biomedical Research LLC, Knoxville, Tennessee, United States
The Sarah Cannon Research Inst, Nashville, Tennessee, United States
Vanderbilt, Nashville, Tennessee, United States
University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
Wellmonth Physician Services, Bristol, Virginia, United States
Blue Ridge Cancer Care - Roanoke, Roanoke, Virginia, United States
VA Puget Sound Health Care Sys, Seattle, Washington, United States
Northwest Medical Specialties, Tacoma, Washington, United States
Clinica Universitaria Reina Fabiola, Cordoba, , Argentina
Instituto FIDES, La Plata, , Argentina
Isis Centro Especializado de Luces; Oncology, Santa Fe, , Argentina
Royal Prince Alfred Hospital; Sydney Cancer Centre, Camperdown, New South Wales, Australia
St Vincent'S Hospital, Darlinghurst, New South Wales, Australia
Calvary Mater Newcastle; Medical Oncology, Waratah, New South Wales, Australia
Flinders Medical Centre; Medical Oncology, Bedford Park, South Australia, Australia
Royal Hobart Hospital; Medical Oncology, Hobart, Tasmania, Australia
Footscray Hospital, Footscray, Victoria, Australia
Royal Melbourne Hospital; Hematology and Medical Oncology, Parkville, Victoria, Australia
Centro de Oncologia da Bahia - CENOB, Salvador, BA, Brazil
Clinica de Tratamento e Pesquisa Oncologica - Oncotek, Brasilia, DF, Brazil
Instituto Nacional de Cancer - INCa; Oncologia, Rio de Janeiro, RJ, Brazil
Liga Norte Riograndense Contra O Câncer, Natal, RN, Brazil
Santa Casa de Misericordia de Porto Alegre, Porto Alegre, RS, Brazil
Hospital Mae de Deus, Porto Alegre, RS, Brazil
Centro de Pesquisas Oncologicas - CEPON, Florianopolis, SC, Brazil
Hospital Amaral Carvalho, Jau, SP, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
Instituto de Oncologia de Sorocaba - CEPOS, Sorocaba, SP, Brazil
Mcgill University - Royal Victoria Hospital; Oncology, Montreal, Quebec, Canada
Hopital du Sacre-Coeur, Montreal, Quebec, Canada
Clinica Santa Maria, Santiago, , Chile
Fundacion Arturo Lopez Perez, Santiago, , Chile
Instituto Oncologico del sur, Temuco, , Chile
Hospital Clinico Vina del Mar, ViĂąa del Mar, , Chile
Hopital Morvan, Brest, , France
Clinique Victor Hugo; Radiotherapie, Le Mans, , France
Clinique Catherine de Sienne; Service de cancĂŠrologie, Nantes, , France
Ico Rene Gauducheau; Oncologie, Saint Herblain, , France
Centre Hospitalier de Villefranche sur Saone, Villefranche-sur-Saone, , France
Institut Gustave Roussy; Departement Oncologie Medicale, Villejuif, , France
Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie, Bad Berka, , Germany
Asklepios-Fachkliniken Muenchen-Gauting; Onkologie, Gauting, , Germany
Krankenhaus Grosshansdorf;Pneumologie & Thoraxchirurgie, Grosshansdorf, , Germany
St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie, Karlsruhe, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie, Mainz, , Germany
Universitätsklinikum Regensburg; Klinik und Poliklinik fßr Innere Medizin II, Pneumologie, Regensburg, , Germany
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo., Ulm, , Germany
Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie, Villingen-Schwenningen, , Germany
Orszagos Koranyi TBC es Pulmonologiai Intezet, Budapest, , Hungary
Koch Robert Korhaz, Edeleny, , Hungary
Veszprem Megyei Onkormanyzat Tudogyogyintezet, Farkasgyepu, , Hungary
Vas Megyei Markusovszky Korhaz ; Pulmonology, Szombathely, , Hungary
Tudogyogyintezet Torokbalint, Torokbalint, , Hungary
Zala Megyei Korhaz; Dept of Pulmonary Medicine, Zalaegerszeg, , Hungary
Shaare Zedek Medical Center; Oncology Dept, Jerusalem, , Israel
Meir Medical Center; Oncology, Kfar-Saba, , Israel
Chaim Sheba Medical Center; Oncology Dept, Ramat Gan, , Israel
Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica, Bologna, Emilia-Romagna, Italy
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica, Aviano, Friuli-Venezia Giulia, Italy
ASST DI MONZA; Oncologia Medica, Monza, Lombardia, Italy
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico, Orbassano, Piemonte, Italy
A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U., Verona, Veneto, Italy
Amphia Ziekenhuis, Breda, , Netherlands
Catharina-ziekenhuis; Longgeneeskunde en Tuberculose, Eindhoven, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Regional Oncology Center, Chelyabinsk, , Russian Federation
Moscow city oncology hospital #62 of Moscow Healthcare Department, Moscow, , Russian Federation
City Oncology Hospital; Chemotherapy Dept, Nizhny Novgorod, , Russian Federation
Leningrad Regional Clinical Hospital, St Petersburg, , Russian Federation
Rsrch Onc Inst of Rosmed Tech; n.a. prof. N.N. Petrov; Dept of Surgery, St. Petersburg, , Russian Federation
Hospital Nuestra SeĂąora de Sonsoles; servicio de Oncologia, Avila, , Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Barcelona, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Puerta de Hierro; Servicio de Oncologia, Madrid, , Spain
Kiev City Clinical Oncology Center, Kiev, , Ukraine
Volyn Regional Oncology Dispensary, Lutsk, , Ukraine
State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department, Lviv, , Ukraine
Crimean Republican Institute; Oncology Clin Dispensary; Chemotherapy Dept, Simferopol, , Ukraine
Sumy Reg. Clin. Oncological Dispensary; Thoracall Department, Sumy, , Ukraine
Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University, Zaporizhzhya, , Ukraine
Royal Surrey County Hospital; St. Lukes Cancer Centre, Guildford, , United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology, Leicester, , United Kingdom
Christie Hospital Nhs Trust; Medical Oncology, Manchester, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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