A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment
Public ClinicalTrials.gov record NCT01801111. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Non-Randomized, Multicenter Phase I/II Trial of RO5424802 Given Orally to Non-Small Cell Lung Cancer Patients Who Have ALK Mutation and Who Have Failed Crizotinib Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01801111
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 138 participants
Conditions and interventions
Conditions
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
- Jun 19, 2013
- Primary completion
- Oct 23, 2014
- Completion
- Oct 26, 2017
- Last update posted
- Nov 1, 2018
2013 – 2017
United States locations
- U.S. sites
- 17
- U.S. states
- 10
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| St. Jude Heritage Healthcare | Fullerton | California | 92835 | — |
| UC Irvine Medical Center | Orange | California | 92868 | — |
| Sharp Memorial Hospital | San Diego | California | 92123 | — |
| Coastal Integrative Cancer Care | San Luis Obispo | California | 93401 | — |
| UCLA Cancer Center; Premiere Oncology, A Medical Corporation | Santa Monica | California | 90404 | — |
| Advanced Medical Specialties | Miami | Florida | 33176 | — |
| Florida Hospital Cancer Inst | Orlando | Florida | 32804 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Midwestern Regional Medical Center; Office of Research | Zion | Illinois | 60099 | — |
| Washington University; Wash Uni. Sch. Of Med | St Louis | Missouri | 63110 | — |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89014 | — |
| Columbia University Medical Center; Department of Hematology/Oncology | New York | New York | 10032 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Texas Oncology, P.A. | Dallas | Texas | 75246 | — |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78217 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
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 67 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01801111, 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 Nov 1, 2018 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01801111 live on ClinicalTrials.gov.