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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 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 134 participants.
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.
Interventions
- DRUG Alectinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2013-09-30 |
| Est. Completion | 2017-08-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01871805
The ClinicalTrials.gov registry entry for NCT01871805 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Alectinib is the first listed.
NCT01871805 reports 0 study locations.
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.
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