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NCT01871805 · ClinicalTrials.gov registry record · Phase 1
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 134
- Enrollment target
NCT01871805: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT01871805 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 134 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01871805, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 134 participants
- Enrollment target
Study 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.
Primary Outcome
The DLTs were defined as any which included Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or Grade 4 neutropenia continuing for greater than equal to (\>=) 7 consecutive days, non-hematological toxicity of Grade 3 or higher (excluding transient electrolyte abnormalities, diarrhea, nausea, and vomiting that recovers to Grade 2 or lower with appropriate treatment and participants having Grade 2 aspartate transaminase (AST) and/or alanine transaminase (ALT) at baseline must hav
Interventions
- DRUG Alectinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2013-09-30 |
| Est. Completion | 2017-08-31 |
| Phase | Phase 1 |
What the finished NCT01871805 record still lists
NCT01871805 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 1 intervention - of which Alectinib is the first listed.
NCT01871805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01871805 about?
NCT01871805 is a clinical study titled "A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)". 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 ...
What is the current status of trial NCT01871805?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 134 participants. The study started on 2013-09-30. Estimated completion is 2017-08-31.
What interventions are being tested in trial NCT01871805?
The interventions under investigation include: Alectinib (DRUG).
Who is sponsoring clinical trial NCT01871805?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01871805's enrollment target sits among peer trials
134 427th of 2000 higher than 1,569 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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