A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
Completed
Hoffmann-La Roche
Phase 1/Phase 2
2013-09-30
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.
A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment
Completed
Hoffmann-La Roche
Phase 1/Phase 2
2013-06-20
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.
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
Completed
Hoffmann-La Roche
Phase 1/Phase 2
2013-09-30
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.
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