A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

June 20, 2013

Primary Completion Date

October 24, 2014

Study Completion Date

October 27, 2017

Conditions
Non-Small-Cell Lung Carcinoma
Interventions
DRUG

Erlotinib

Erlotinib will be administered at a dose of 100 mg via tablet, orally, once daily in combination with alectinib to participants who progressed on alectinib alone treatment as per treating physician discretion.

DRUG

Alectinib

Alectinib will be administered at a dose of 600 milligrams (mg) via capsule, orally, twice daily.

Trial Locations (84)

407

Taichung Veterans General Hospital, Taichung

1210

Centre Hospitalier de Luxembourg, Luxembourg

2065

Royal North Shore Hospital, St Leonards

2650

UZ Antwerpen, Edegem

2730

University Hospital Herlev, Herlev

4032

Prince Charles Hospital, Chermside

4184

Townsville General Hospital, Douglas

6351

Samsung Medical Center, Seoul

8800

AZ Delta (Campus Wilgenstraat), Roeselare

9000

UZ Gent, Ghent

10002

National Taiwan University Hospital, Taipei

10032

Columbia University Medical Center; Department of Hematology/Oncology, New York

10408

National Cancer Center, Gyeonggi-do

13353

Charité Campus Virchow-Klinikum; Department of Cardiology, Berlin

13620

Seoul National University Bundang Hospital, Gyeonggi-do

13915

Hôpital Nord - AP-HM Marseille#; Gastroenterology and Hepatology, Marseille

14076

Centre Francois Baclesse, Caen

17176

Karolinska, Stockholm

20132

Ospedale San Raffaele, Milan

20141

Istituto Europeo Di Oncologia, Milan

21000

Centre Georges François Leclerc; Service Pharmacie, Bp 77980, Dijon

22031

Virginia Cancer Specialists, PC, Fairfax

22927

LungenClinic Großhansdorf, Großhansdorf

28034

Hospital Universitario Ramón y Cajal, Madrid

28040

Hospital Universitario Clínico San Carlos; Servicio de Oncologia, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

29010

Hospital Regional Universitario de Malaga, Málaga

29200

Hopital Morvan, Brest

31059

CHU de Toulouse - Hôpital Larrey, Toulouse

32804

Florida Hospital Cancer Inst, Orlando

33081

Irccs Centro Di Riferimento Oncologico (CRO), Aviano

33176

Advanced Medical Specialties, Miami

33600

Groupe Hospitalier Sud - Hôpital Haut Lévêque, Pessac

35033

Hopital Pontchaillou - CHU de Rennes, Rennes

35233

University of Alabama at Birmingham, Birmingham

38043

CHU de Grenoble - Hôpital Nord; Service d'Oncologie Thoracique, Grenoble

40489

Diakonie Kaiserswerth; Florence-Nightingale-Krankenhaus, Düsseldorf

43100

A.O. Universitaria Di Parma, Parma

44106

University Hospitals Case Medical Center, Cleveland

44805

ICO Rene Gauducheau; CEC, Saint-Herblain

48431

Mathias-Spital Rheine, Rheine

49933

CHU Angers - Hôpital Hôtel Dieu, Angers

50009

Hosp Clinico Univ Lozano Blesa, Zaragoza

50141

Azienda Ospedaliera Universitaria Careggi, Florence

51109

Klinikum Koeln-Merheim, Cologne

55043

Ospedale Versilia, Lido di Camaiore

55100

Presidio Ospedaliero Campo di Marte, Lucca

58675

Lungenklinik Hemer, Hemer

59020

Centre Oscar Lambret, Lille

60099

Midwestern Regional Medical Center; Office of Research, Zion

60612

Rush University Medical Center, Chicago

63110

Washington University; Wash Uni. Sch. Of Med, St Louis

67091

Nouvel Hopital Civil - CHU Strasbourg, Strasbourg

69008

Centre Leon Berard, Lyon

75246

Texas Oncology, P.A., Dallas

78217

Cancer Care Centers of South Texas, San Antonio

89014

Comprehensive Cancer Centers of Nevada, Henderson

90404

UCLA Cancer Center; Premiere Oncology, A Medical Corporation, Santa Monica

92123

Sharp Memorial Hospital, San Diego

92835

St. Jude Heritage Healthcare, Fullerton

92868

UC Irvine Medical Center, Orange

93401

Coastal Integrative Cancer Care, San Luis Obispo

115478

"FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin; Chemotherapy Departement", Moskva

119074

National University Hospital; Investigational Medicine Unit, Singapore

280146

Hospital Universitario La Paz, Madrid

308433

Johns Hopkins Singapore, Singapore

00144

Istituto Nazionale Tumori Regina Elena IRCCS, Rome

00149

AO San Camillo Forlanini, Rome

Unknown

Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda), Milan

06100

Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia, Perugia

1066 CX

Antoni van Leeuwenhoek Ziekenhuis, Amsterdam

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

6229HX

Maastricht University Medical Centre; Afdeling Klinische Farmacie en Toxicologie, Maastricht

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System; Pharmacy, Seoul

05505

Asan Medical Center, Seoul

03010

Hospital General Univ. de Alicante, Alicante

08003

Hospital del Mar, Barcelona

08028

Hospital Universitario Quiron Dexeus, Barcelona

08036

Hospital Clínic i Provincial de Barcelona, Barcelona

00704

National Cheng Kung Univ Hosp, Tainan City

AB25 2ZN

Aberdeen Royal Infirmary, Aberdeen

SW3 6HP

Royal Marsden Hospital;Dept of Haematology Oncology Research, London

SW3 6JJ

Royal Marsden Hospital - London, London

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01801111 - A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment | Biotech Hunter | Biotech Hunter