Lung Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

134

Study ID:

NCT01871805

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 41 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35233, United States
University of California Irvine
Irvine California, 92697, United States
UCSD Moores Cancer Center
La Jolla California, 92093, United States
Loma Linda Cancer Center
Loma Linda California, 92354, United States
UCLA
Los Angeles California, 90095, United States
Univ of Colorado Canc Ctr
Aurora Colorado, 80045, United States
National Jewish Health
Denver Colorado, 80206, United States
Lynn Regional Cancer Center West
Boca Raton Florida, 33486, United States
Florida Hospital Cancer Inst
Orlando Florida, 32804, United States
UF Health Orlando
Orlando Florida, 32806, United States
H. Lee Moffitt Cancer Center and Research Inst.
Tampa Florida, 33612, United States
University of Illinois Cancer Center
Chicago Illinois, 60612, United States
Monroe Medical Associates; Ingalls Memorial Hosp
Harvey Illinois, 60426, United States
Massachussets General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana Farber Can Ins
Boston Massachusetts, 02215, United States
Newton-Wellesley Hospital
Newton Massachusetts, 02462, United States
St. Joseph Mercy Hospital; Cancer Care Center.
Ann Arbor Michigan, 48106, United States
Wayne State Uni ; Karmanos Cancer Center
Detroit Michigan, 48201, United States
Hackensack Univ Med Ctr
Hackensack New Jersey, 07601, United States
Roswell Park Cancer Inst.
Buffalo New York, 14263, United States
Memorial Sloan-Kettering Cancer Center
Commack New York, 11725, United States
Richmond University Medical Center; Pharmacy Department
Staten Island New York, 10310, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
The Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Providence Portland Med Ctr
Portland Oregon, 97213, United States
Oregon Health & Science Uni
Portland Oregon, 97239, United States
St. Luke's Hospital; Pharmacy Department
Bethlehem Pennsylvania, 18015, United States
Penn State Hershey Cancer Institute
Hershey Pennsylvania, 17033, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
University of Pittsburgh Cancer Pavillion
Pittsburgh Pennsylvania, 15232, United States
MUSC Hollings Cancer Center
Charleston South Carolina, 29425, United States
Center for Biomedical Research LLC
Knoxville Tennessee, 37909, United States
Texas Oncology-Baylor Sammons Cancer Center
Dallas Texas, 75246, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Swedish Cancer Inst.
Seattle Washington, 98104, United States
University of Wisconsin
Madison Wisconsin, 53792, United States
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Lakeridge Health Oshawa; Oncology
Oshawa Ontario, L1G 2, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal Quebec, H3T 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

134

Study ID:

NCT01871805

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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