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 |
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.
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
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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4805 Northeast Glisan Street
Portland, Oregon 97213
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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1801 West Taylor, Suite 1E
Chicago, Illinois 60612
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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National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
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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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Newton-Wellesley Hospital A comprehensive medical center located right in Newton on Washington Street, Newton-Wellesley Hospital...
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355 Bard Avenue
Staten Island, New York 10310
Staten Island, New York 10310
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
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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