Spots Global Cancer Trial Database for A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment
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Trial Identification
Brief Title: A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment
Official Title: An Open-Label, Non-Randomized, Multicenter Phase I/II Trial of RO5424802 Given Orally to Non-Small Cell Lung Cancer Patients Who Have ALK Mutation and Who Have Failed Crizotinib Treatment
Study ID: NCT01801111
Conditions
Study Description
Brief Summary: This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
St. Jude Heritage Healthcare, Fullerton, California, United States
UC Irvine Medical Center, Orange, California, United States
Sharp Memorial Hospital, San Diego, California, United States
Coastal Integrative Cancer Care, San Luis Obispo, California, United States
UCLA Cancer Center; Premiere Oncology, A Medical Corporation, Santa Monica, California, United States
Advanced Medical Specialties, Miami, Florida, United States
Florida Hospital Cancer Inst, Orlando, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Midwestern Regional Medical Center; Office of Research, Zion, Illinois, United States
Washington University; Wash Uni. Sch. Of Med, Saint Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Columbia University Medical Center; Department of Hematology/Oncology, New York, New York, United States
University Hospitals Case Medical Center, Cleveland, Ohio, United States
Texas Oncology, P.A., Dallas, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Royal North Shore Hospital, St. Leonards, New South Wales, Australia
Prince Charles Hospital, Chermside, Queensland, Australia
Townsville General Hospital, Douglas, Queensland, Australia
UZ Antwerpen, Edegem, , Belgium
UZ Gent, Gent, , Belgium
AZ Delta (Campus Wilgenstraat), Roeselare, , Belgium
University Hospital Herlev, Herlev, , Denmark
CHU Angers - H么pital H么tel Dieu, Angers, , France
Hopital Morvan, Brest, , France
Centre Francois Baclesse, Caen, , France
Centre Georges Fran莽ois Leclerc; Service Pharmacie, Bp 77980, Dijon, , France
CHU de Grenoble - H么pital Nord; Service d'Oncologie Thoracique, Grenoble, , France
Centre Oscar Lambret, Lille, , France
Centre Leon Berard, Lyon, , France
H么pital Nord - AP-HM Marseille#; Gastroenterology and Hepatology, Marseille cedex 20, , France
Groupe Hospitalier Sud - H么pital Haut L茅v锚que, Pessac, , France
Hopital Pontchaillou - CHU de Rennes, Rennes, , France
ICO Rene Gauducheau; CEC, St Herblain, , France
Nouvel Hopital Civil - CHU Strasbourg, Strasbourg, , France
CHU de Toulouse - H么pital Larrey, Toulouse, , France
Charit茅 Campus Virchow-Klinikum; Department of Cardiology, Berlin, , Germany
Diakonie Kaiserswerth; Florence-Nightingale-Krankenhaus, D眉sseldorf, , Germany
LungenClinic Gro脽hansdorf, Gro脽hansdorf, , Germany
Lungenklinik Hemer, Hemer, , Germany
Klinikum Koeln-Merheim, Koeln, , Germany
Mathias-Spital Rheine, Rheine, , Germany
A.O. Universitaria Di Parma, Parma, Emilia-Romagna, Italy
Irccs Centro Di Riferimento Oncologico (CRO), Aviano, Friuli-Venezia Giulia, Italy
Istituto Nazionale Tumori Regina Elena IRCCS, Roma, Lazio, Italy
AO San Camillo Forlanini, Roma, Lazio, Italy
Ospedale San Raffaele, Milano, Lombardia, Italy
Istituto Europeo Di Oncologia, Milano, Lombardia, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda), Milano, Lombardia, Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, Toscana, Italy
Ospedale Versilia, Lido Di Camaiore, Toscana, Italy
Presidio Ospedaliero Campo di Marte, Lucca, Toscana, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia, Perugia, Umbria, Italy
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Seoul National University Bundang Hospital, Gyeonggi-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System; Pharmacy, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Centre Hospitalier de Luxembourg, Luxembourg, , Luxembourg
Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Maastricht University Medical Centre; Afdeling Klinische Farmacie en Toxicologie, Maastricht, , Netherlands
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"; Chemotherapy Departement, Moskva, Moskovskaja Oblast, Russian Federation
National University Hospital; Investigational Medicine Unit, Singapore, , Singapore
Johns Hopkins Singapore, Singapore, , Singapore
Hospital General Univ. de Alicante, Alicante, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Universitario Quiron Dexeus, Barcelona, , Spain
Hospital Cl铆nic i Provincial de Barcelona, Barcelona, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Ram贸n y Cajal, Madrid, , Spain
Hospital Universitario Cl铆nico San Carlos; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Regional Universitario de Malaga, Malaga, , Spain
Hosp Clinico Univ Lozano Blesa, Zaragoza, , Spain
Karolinska, Stockholm, , Sweden
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung Univ Hosp, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Aberdeen Royal Infirmary, Aberdeen, , United Kingdom
Royal Marsden Hospital;Dept of Haematology Oncology Research, London, , United Kingdom
Royal Marsden Hospital - London, London, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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