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Last Updated: March 1, 2024

CLINICAL TRIALS PROFILE FOR ALECTINIB HYDROCHLORIDE


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All Clinical Trials for Alectinib Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01588028 ↗ 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.
NCT01801111 ↗ 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.
NCT01871805 ↗ 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.
NCT01984229 ↗ A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers Completed Hoffmann-La Roche Phase 1 2013-12-01 This open-label study will investigate whether multiple oral doses of posaconazole affect the single dose pharmacokinetics of alectinib in healthy volunteers.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Alectinib Hydrochloride

Condition Name

Condition Name for Alectinib Hydrochloride
Intervention Trials
Non-Small Cell Lung Cancer 16
Neoplasms 4
Cancer 3
Solid Tumor 3
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Condition MeSH

Condition MeSH for Alectinib Hydrochloride
Intervention Trials
Carcinoma, Non-Small-Cell Lung 31
Lung Neoplasms 27
Neoplasms 10
Lymphoma 6
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Clinical Trial Locations for Alectinib Hydrochloride

Trials by Country

Trials by Country for Alectinib Hydrochloride
Location Trials
United States 313
Italy 79
Spain 39
Australia 30
Canada 26
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Trials by US State

Trials by US State for Alectinib Hydrochloride
Location Trials
California 22
Texas 19
New York 16
Florida 15
Michigan 14
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Clinical Trial Progress for Alectinib Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Alectinib Hydrochloride
Clinical Trial Phase Trials
Phase 4 2
Phase 3 7
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Alectinib Hydrochloride
Clinical Trial Phase Trials
Recruiting 32
Completed 11
Active, not recruiting 6
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Clinical Trial Sponsors for Alectinib Hydrochloride

Sponsor Name

Sponsor Name for Alectinib Hydrochloride
Sponsor Trials
Hoffmann-La Roche 24
Genentech, Inc. 8
Ariad Pharmaceuticals 3
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Sponsor Type

Sponsor Type for Alectinib Hydrochloride
Sponsor Trials
Other 74
Industry 64
NIH 1
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