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Completed Phase 1Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT01871805

Public ClinicalTrials.gov record NCT01871805. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 2:38 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01871805
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
134 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2013 (Actual)
Primary completion
Oct 24, 2014 (Actual)
Completion
Aug 31, 2017 (Actual)
Last update posted
Aug 21, 2018

2013 – 2017

United States locations

U.S. sites
39
U.S. states
19
U.S. cities
35
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 —
University of California Irvine Irvine California 92697 —
UCSD Moores Cancer Center La Jolla California 92093 —
Loma Linda Cancer Center Loma Linda California 92354 —
UCLA Los Angeles California 90095 —
Univ of Colorado Canc Ctr Aurora Colorado 80045 —
National Jewish Health Denver Colorado 80206 —
Lynn Regional Cancer Center West Boca Raton Florida 33486 —
Florida Hospital Cancer Inst Orlando Florida 32804 —
UF Health Orlando Orlando Florida 32806 —
H. Lee Moffitt Cancer Center and Research Inst. Tampa Florida 33612 —
University of Illinois Cancer Center Chicago Illinois 60612 —
Monroe Medical Associates; Ingalls Memorial Hosp Harvey Illinois 60426 —
Massachussets General Hospital Boston Massachusetts 02114 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Dana Farber Can Ins Boston Massachusetts 02215 —
Newton-Wellesley Hospital Newton Massachusetts 02462 —
St. Joseph Mercy Hospital; Cancer Care Center. Ann Arbor Michigan 48106 —
Wayne State Uni ; Karmanos Cancer Center Detroit Michigan 48201 —
Hackensack Univ Med Ctr Hackensack New Jersey 07601 —
Roswell Park Cancer Inst. Buffalo New York 14263 —
Memorial Sloan-Kettering Cancer Center Commack New York 11725 —
Richmond University Medical Center; Pharmacy Department Staten Island New York 10310 —
Wake Forest University Health Sciences Winston-Salem North Carolina 27157 —
Gabrail Cancer Center Canton Ohio 44718 —
The Ohio State University Comprehensive Cancer Center Columbus Ohio 43210 —
Providence Portland Med Ctr Portland Oregon 97213 —
Oregon Health & Science Uni Portland Oregon 97239 —
St. Luke's Hospital; Pharmacy Department Bethlehem Pennsylvania 18015 —
Penn State Hershey Cancer Institute Hershey Pennsylvania 17033 —
Fox Chase Cancer Center Philadelphia Pennsylvania 19111 —
University of Pittsburgh Cancer Pavillion Pittsburgh Pennsylvania 15232 —
MUSC Hollings Cancer Center Charleston South Carolina 29425 —
Center for Biomedical Research LLC Knoxville Tennessee 37909 —
Texas Oncology-Baylor Sammons Cancer Center Dallas Texas 75246 —
MD Anderson Cancer Center Houston Texas 77030 —
Virginia Cancer Specialists, PC Fairfax Virginia 22031 —
Swedish Cancer Inst. Seattle Washington 98104 —
University of Wisconsin Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01871805, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 21, 2018 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01871805 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →