Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Locally advanced or metastatic non-small cell lung cancer (stage IIIB or IV by American Joint Committee on Cancer [AJCC])
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 other ALK inhibitors in addition to crizotinib
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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

138

Study ID:

NCT01801111

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 82 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35233, United States
St. Jude Heritage Healthcare
Fullerton California, 92835, United States
UC Irvine Medical Center
Orange California, 92868, United States
Sharp Memorial Hospital
San Diego California, 92123, United States
Coastal Integrative Cancer Care
San Luis Obispo California, 93401, United States
UCLA Cancer Center; Premiere Oncology, A Medical Corporation
Santa Monica California, 90404, United States
Advanced Medical Specialties
Miami Florida, 33176, United States
Florida Hospital Cancer Inst
Orlando Florida, 32804, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Midwestern Regional Medical Center; Office of Research
Zion Illinois, 60099, United States
Washington University; Wash Uni. Sch. Of Med
Saint Louis Missouri, 63110, United States
Comprehensive Cancer Centers of Nevada
Henderson Nevada, 89014, United States
Columbia University Medical Center; Department of Hematology/Oncology
New York New York, 10032, United States
University Hospitals Case Medical Center
Cleveland Ohio, 44106, United States
Texas Oncology, P.A.
Dallas Texas, 75246, United States
Cancer Care Centers of South Texas
San Antonio Texas, 78217, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Royal North Shore Hospital
St. Leonards New South Wales, 2065, Australia
Prince Charles Hospital
Chermside Queensland, 4032, Australia
Townsville General Hospital
Douglas Queensland, 4184, Australia
UZ Antwerpen
Edegem , 2650, Belgium
UZ Gent
Gent , 9000, Belgium
AZ Delta (Campus Wilgenstraat)
Roeselare , 8800, Belgium
University Hospital Herlev
Herlev , 2730, Denmark
CHU Angers - Hôpital Hôtel Dieu
Angers , 49933, France
Hopital Morvan
Brest , 29200, France
Centre Francois Baclesse
Caen , 14076, France
Centre Georges François Leclerc; Service Pharmacie, Bp 77980
Dijon , 21000, France
CHU de Grenoble - Hôpital Nord; Service d'Oncologie Thoracique
Grenoble , 38043, France
Centre Oscar Lambret
Lille , 59020, France
Centre Leon Berard
Lyon , 69008, France
Hôpital Nord - AP-HM Marseille#; Gastroenterology and Hepatology
Marseille cedex 20 , 13915, France
Groupe Hospitalier Sud - Hôpital Haut Lévêque
Pessac , 33600, France
Hopital Pontchaillou - CHU de Rennes
Rennes , 35033, France
ICO Rene Gauducheau; CEC
St Herblain , 44805, France
Nouvel Hopital Civil - CHU Strasbourg
Strasbourg , 67091, France
CHU de Toulouse - Hôpital Larrey
Toulouse , 31059, France
Charité Campus Virchow-Klinikum; Department of Cardiology
Berlin , 13353, Germany
Diakonie Kaiserswerth; Florence-Nightingale-Krankenhaus
Düsseldorf , 40489, Germany
LungenClinic Großhansdorf
Großhansdorf , 22927, Germany
Lungenklinik Hemer
Hemer , 58675, Germany
Klinikum Koeln-Merheim
Koeln , 51109, Germany
Mathias-Spital Rheine
Rheine , 48431, Germany
A.O. Universitaria Di Parma
Parma Emilia-Romagna, 43100, Italy
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano Friuli-Venezia Giulia, 33081, Italy
Istituto Nazionale Tumori Regina Elena IRCCS
Roma Lazio, 00144, Italy
AO San Camillo Forlanini
Roma Lazio, 00149, Italy
Ospedale San Raffaele
Milano Lombardia, 20132, Italy
Istituto Europeo Di Oncologia
Milano Lombardia, 20141, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
Milano Lombardia, , Italy
Azienda Ospedaliera Universitaria Careggi
Firenze Toscana, 50141, Italy
Ospedale Versilia
Lido Di Camaiore Toscana, 55043, Italy
Presidio Ospedaliero Campo di Marte
Lucca Toscana, 55100, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia Umbria, 06100, Italy
National Cancer Center
Gyeonggi-do , 10408, Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-do , 13620, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System; Pharmacy
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 6351, Korea, Republic of
Centre Hospitalier de Luxembourg
Luxembourg , 1210, Luxembourg
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam , 1066 , Netherlands
Universitair Medisch Centrum Groningen
Groningen , 9713 , Netherlands
Maastricht University Medical Centre; Afdeling Klinische Farmacie en Toxicologie
Maastricht , 6229H, Netherlands
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"; Chemotherapy Departement
Moskva Moskovskaja Oblast, 11547, Russian Federation
National University Hospital; Investigational Medicine Unit
Singapore , 11907, Singapore
Johns Hopkins Singapore
Singapore , 30843, Singapore
Hospital General Univ. de Alicante
Alicante , 03010, Spain
Hospital del Mar
Barcelona , 08003, Spain
Hospital Universitario Quiron Dexeus
Barcelona , 08028, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona , 08036, Spain
Hospital Universitario La Paz
Madrid , 28014, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Regional Universitario de Malaga
Malaga , 29010, Spain
Hosp Clinico Univ Lozano Blesa
Zaragoza , 50009, Spain
Karolinska
Stockholm , 17176, Sweden
Taichung Veterans General Hospital
Taichung , 407, Taiwan
National Cheng Kung Univ Hosp
Tainan , 00704, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Aberdeen Royal Infirmary
Aberdeen , AB25 , United Kingdom
Royal Marsden Hospital;Dept of Haematology Oncology Research
London , SW3 6, United Kingdom
Royal Marsden Hospital - London
London , SW3 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

138

Study ID:

NCT01801111

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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