A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment
NCT ID: NCT01801111
Last Updated: 2018-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
138 participants
INTERVENTIONAL
2013-06-20
2017-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Alectinib
Participants will receive alectinib treatment continuously starting from Day 1 Cycle 1 (in 28-day cycles) until disease progression, death, or withdrawal for any other reasons, whichever occurs first. After PD, participants without EGFR mutation will continue treatment with alectinib alone and participants with EGFR mutation will receive alectinib in combination with erlotinib as per discretion of the treating physician.
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.
Alectinib
Alectinib will be administered at a dose of 600 milligrams (mg) via capsule, orally, twice daily.
Interventions
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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.
Alectinib
Alectinib will be administered at a dose of 600 milligrams (mg) via capsule, orally, twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Documented ALK rearrangement based on Food and Drug Administration (FDA)-approved test
* Prior treatment with crizotinib and progression according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria. Participants had to have a minimum 1-week wash-out period between the last dose of crizotinib and the first dose of study treatment. Participants can either be chemotherapy-naïve or have received at least one line of platinum-based chemotherapy
* Adequate hematologic, hepatic, and renal function
* Participants with brain or leptomeningeal metastases are allowed if protocol defined criteria are met
* Measurable disease according to RECIST v1.1 prior to administration of first dose of study drug
Exclusion Criteria
* Receipt of any prior cytotoxic chemotherapy for ALK-positive NSCLC within 4 weeks prior to the first dose of study drug
* Participants who received crizotinib or any other tyrosine kinase inhibitors need to have a minimum 1-week washout period before the first dose of study drug
* Active or uncontrolled infectious diseases requiring treatment
* National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) Grade 3 or higher toxicities due to prior therapy that have not shown improvement and are considered to interfere with current study medication
* History of organ transplant
* Co-administration of anti-cancer therapies other than those administered in this study
* Baseline corrected Q-T interval (QTc) greater than (\>) 470 milliseconds, or baseline symptomatic bradycardia (less than 45 heart beats per minute)
* Pregnant or breastfeeding women
* Known Human Immunodeficiency Virus (HIV) positivity or Acquired Immunodeficiency Syndrome (AIDS)-related illness
* History of hypersensitivity to any of the additives in the alectinib formulation
* Any clinically significant concomitant disease or condition that could interfere with, or for which treatment might interfere with, the conduct of the study, or absorption of oral medications, or that would, in the opinion of the principal investigator, pose an unacceptable risk to the participant in the study
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
St 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
Ghent, , Belgium
AZ Delta (Campus Wilgenstraat)
Roeselare, , Belgium
University Hospital Herlev
Herlev, , Denmark
CHU Angers - Hôpital Hôtel Dieu
Angers, , France
Hopital Morvan
Brest, , France
Centre Francois Baclesse
Caen, , France
Centre Georges François Leclerc; Service Pharmacie, Bp 77980
Dijon, , France
CHU de Grenoble - Hôpital Nord; Service d'Oncologie Thoracique
Grenoble, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Hôpital Nord - AP-HM Marseille#; Gastroenterology and Hepatology
Marseille, , France
Groupe Hospitalier Sud - Hôpital Haut Lévêque
Pessac, , France
Hopital Pontchaillou - CHU de Rennes
Rennes, , France
ICO Rene Gauducheau; CEC
Saint-Herblain, , France
Nouvel Hopital Civil - CHU Strasbourg
Strasbourg, , France
CHU de Toulouse - Hôpital Larrey
Toulouse, , France
Charité Campus Virchow-Klinikum; Department of Cardiology
Berlin, , Germany
Klinikum Koeln-Merheim
Cologne, , Germany
Diakonie Kaiserswerth; Florence-Nightingale-Krankenhaus
Düsseldorf, , Germany
LungenClinic Großhansdorf
Großhansdorf, , Germany
Lungenklinik Hemer
Hemer, , 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
Rome, Lazio, Italy
AO San Camillo Forlanini
Rome, Lazio, Italy
Ospedale San Raffaele
Milan, Lombardy, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Ospedale Versilia
Lido di Camaiore, Tuscany, Italy
Presidio Ospedaliero Campo di Marte
Lucca, Tuscany, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia, Umbria, Italy
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, Moscow Oblast, Russia
National University Hospital; Investigational Medicine Unit
Singapore, , Singapore
Johns Hopkins Singapore
Singapore, , Singapore
National Cancer Center
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System; Pharmacy
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital General Univ. de Alicante
Alicante, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitario Quiron Dexeus
Barcelona, , Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hosp Clinico Univ Lozano Blesa
Zaragoza, , Spain
Karolinska
Stockholm, , Sweden
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung Univ Hosp
Tainan City, , 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
Countries
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References
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Ou SI, Gadgeel SM, Barlesi F, Yang JC, De Petris L, Kim DW, Govindan R, Dingemans AM, Crino L, Lena H, Popat S, Ahn JS, Dansin E, Mitry E, Muller B, Bordogna W, Balas B, Morcos PN, Shaw AT. Pooled overall survival and safety data from the pivotal phase II studies (NP28673 and NP28761) of alectinib in ALK-positive non-small-cell lung cancer. Lung Cancer. 2020 Jan;139:22-27. doi: 10.1016/j.lungcan.2019.10.015. Epub 2019 Oct 14.
Morcos PN, Nueesch E, Jaminion F, Guerini E, Hsu JC, Bordogna W, Balas B, Mercier F. Exposure-response analysis of alectinib in crizotinib-resistant ALK-positive non-small cell lung cancer. Cancer Chemother Pharmacol. 2018 Jul;82(1):129-138. doi: 10.1007/s00280-018-3597-5. Epub 2018 May 10.
Gadgeel SM, Shaw AT, Govindan R, Gandhi L, Socinski MA, Camidge DR, De Petris L, Kim DW, Chiappori A, Moro-Sibilot DL, Duruisseaux M, Crino L, De Pas T, Dansin E, Tessmer A, Yang JC, Han JY, Bordogna W, Golding S, Zeaiter A, Ou SI. Pooled Analysis of CNS Response to Alectinib in Two Studies of Pretreated Patients With ALK-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Dec;34(34):4079-4085. doi: 10.1200/JCO.2016.68.4639. Epub 2016 Oct 31.
Other Identifiers
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2012-004455-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NP28673
Identifier Type: -
Identifier Source: org_study_id
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