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NCT01801111 · ClinicalTrials.gov registry record · Phase 1
A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment
A Phase 1 study of Non-Small-Cell Lung Carcinoma, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 138
- Enrollment target
- 20
- Study locations
NCT01801111: Completed Phase 1 study of Non-Small-Cell Lung Carcinoma, sponsored by Hoffmann-La Roche.
NCT01801111 is a Phase 1 study of Non-Small-Cell Lung Carcinoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 138 participants, below the 231-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01801111, a Phase 1 study of Non-Small-Cell Lung Carcinoma, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 138 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
RP2D was to be determined based on the safety and tolerability profile of the study treatment.
Conditions Studied
Interventions
- DRUG Alectinib
- DRUG Erlotinib
Study Locations (20)
California
- St. Jude Heritage Healthcare - Fullerton
- UC Irvine Medical Center - Orange
- Sharp Memorial Hospital - San Diego
- Coastal Integrative Cancer Care - San Luis Obispo
- UCLA Cancer Center; Premiere Oncology, A Medical Corporation - Santa Monica
Florida
- Advanced Medical Specialties - Miami
- Florida Hospital Cancer Inst - Orlando
Illinois
- Rush University Medical Center - Chicago
- Midwestern Regional Medical Center; Office of Research - Zion
Texas
- Texas Oncology, P.A. - Dallas
- Cancer Care Centers of South Texas - San Antonio
Queensland
- Prince Charles Hospital - Chermside
- Townsville General Hospital - Douglas
Alabama
- University of Alabama at Birmingham - Birmingham
Missouri
- Washington University; Wash Uni. Sch. Of Med - St Louis
Nevada
- Comprehensive Cancer Centers of Nevada - Henderson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2013-06-20 |
| Est. Completion | 2017-10-27 |
| Phase | Phase 1 |
What the finished NCT01801111 record still lists
NCT01801111 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 231-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Non-Small-Cell Lung Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Alectinib is the first listed.
NCT01801111 names 20 study sites across 12 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT01801111 about?
NCT01801111 is a clinical study titled "A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment". 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...
What is the current status of trial NCT01801111?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 138 participants. The study started on 2013-06-20. Estimated completion is 2017-10-27.
What conditions does trial NCT01801111 study?
This clinical trial studies the following conditions: Non-Small-Cell Lung Carcinoma.
What interventions are being tested in trial NCT01801111?
The interventions under investigation include: Alectinib (DRUG), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT01801111?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01801111 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01801111's enrollment target sits among peer trials
138 14th of 30 higher than 17 of 30 other Non-Small-Cell Lung Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small-Cell Lung Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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