A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)



Status:Completed
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/23/2018
Start Date:September 30, 2013
End Date:August 31, 2017

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A Phase I/II Study of the ALK Inhibitor CH5424802/ RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer Previously Treated With Crizotinib

This non-randomized, open-label, multicenter study will evaluate the safety and efficacy of
alectinib in participants with ALK-rearranged non-small cell lung cancer who failed
crizotinib treatment. In Phase I, cohorts of participants will receive escalating doses of
alectinib orally twice daily. In Phase II, patients who failed crizotinib treatment will
receive the recommended phase II dose.


Inclusion Criteria:

- Histologically confirmed, locally advanced, not amenable to curative therapy, or
metastatic NSCLC

- ALK-rearrangement confirmed by the Food and Drug Administration (FDA) approved test

- NSCLC that has failed crizotinib treatment

- Measurable disease as defined by RECIST v1.1

- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
(<=) 2

- Adequate hematologic, hepatic and renal function

Exclusion Criteria:

- Prior therapy with ALK inhibitor other than crizotinib

- Brain or leptomeningeal metastases that are symptomatic and/or requiring treatment

- History of serious cardiac dysfunction

- History of or current active infection with hepatitis B, hepatitis C or human
immunodeficiency virus (HIV)

- Clinically significant gastrointestinal abnormality that would affect absorption of
the drug

- Pregnant or lactating women
We found this trial at
40
sites
Los Angeles, California 90095
(310) 825-4321
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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Ann Arbor, MI
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1665 Aurora Court
Aurora, Colorado 80045
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801 Ostrum Street
Bethlehem, Pennsylvania 18015
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Boca Raton, Florida 33428
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Boston, Massachusetts 02114
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450 Brookline Avenue
Boston, Massachusetts 02215
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Buffalo, New York 14263
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Charleston, South Carolina 29425
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1801 West Taylor, Suite 1E
Chicago, Illinois 60612
312.355.1625
University of Illinois Cancer Center The University of Illinois Cancer Center is dedicated to reducing...
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Commack, New York 11725
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Edmonton, Alberta
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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1 Ingalls Drive
Harvey, Illinois 60426
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Hershey, Pennsylvania 17033
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Houston, Texas 77030
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Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Knoxville, Tennessee 37909
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La Jolla, California 92093
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Loma Linda, California 92354
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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2014 Washington St
Newton, Massachusetts 02462
(617) 243-6000
Newton-Wellesley Hospital A comprehensive medical center located right in Newton on Washington Street, Newton-Wellesley Hospital...
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2501 North Orange Avenue
Orlando, Florida 32804
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Orlando, Florida 32806
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Philadelphia, Pennsylvania 19111
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5150 Centre Avenue
Pittsburgh, Pennsylvania 15232
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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Seattle, Washington 98104
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355 Bard Avenue
Staten Island, New York 10310
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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