At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 134 enrolled
Drug / intervention
Alectinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Alectinib for Non-Small Cell Lung Cancer. Completed, enrolled 134 participants across 42 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 2013
Enrollment StartSep 2013
Primary CompletionOct 2014
Study CompletionAug 2017
TodayJul 2026
First PostedJun 7, 2013
Enrollment StartSep 30, 2013
Primary CompletionOct 24, 2014
Study CompletionAug 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.1 years ago
Interventions
Alectinibdrug
Participants will receive alectinib as described in the arm descriptions.