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Last Updated: November 27, 2022

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.
NCT02013219 ↗ A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer (NSCLC) Completed Hoffmann-La Roche Phase 1 2014-04-03 This open-label, multicenter study will assess the safety, tolerability, and pharmacokinetics of intravenous (IV) dosing of atezolizumab in combination with oral erlotinib or alectinib in participants with NSCLC. This study has two stages. In the erlotinib group, the combination treatment will be given to participants with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-treatment-naive, advanced (nonresectable) NSCLC in a safety-evaluation stage and to participants with previously untreated EGFR mutation-positive, advanced NSCLC in an expansion stage (Stage 2). In the alectinib group, for both the safety-evaluation and expansion stages (Stages 1 and 2), the combination will be given to participants who are treatment-naive with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. In Stage 1, erlotinib will be given at a starting dose of 150 milligrams (mg) by mouth (PO) once daily (QD) and the starting dose of alectinib will be 600 mg twice daily (BID), for 28 consecutive days during Cycle 1 and on Days 1 through 21 of each cycle thereafter. The starting dose of atezolizumab will be 1200 mg, administered every 3 weeks (q3W) starting on Day 8 of Cycle 1. If the starting regimen for a combination treatment is not tolerated, alternative doses and/or schedules of erlotinib and atezolizumab or alectinib and atezolizumab may be tested to determine potential recommended Phase 2 dose (RP2D) for that combination treatment. In Stage 2, a potential RP2D and schedule for each combination treatment will be investigated in an expansion cohort. For both stages, continuation of treatment beyond Cycle 1 will be at the discretion of the treating investigator. Study treatment will be discontinued in participants who experience disease progression or unacceptable toxicity, are not compliant with the study protocol, or, in their opinion or in the opinion of the investigator, are not benefiting from study treatment. However, in the absence of unacceptable toxicity, participants with second-line or greater NSCLC who are still receiving atezolizumab at the time of radiographic disease progression may be permitted to continue study treatment.
>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
Solid Tumors 3
Carcinoma, Non-Small-Cell Lung 3
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Condition MeSH

Condition MeSH for Alectinib Hydrochloride
Intervention Trials
Carcinoma, Non-Small-Cell Lung 30
Lung Neoplasms 26
Neoplasms 8
Lymphoma 5
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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 1
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Clinical Trial Status

Clinical Trial Status for Alectinib Hydrochloride
Clinical Trial Phase Trials
Recruiting 28
Completed 11
Not yet recruiting 6
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Clinical Trial Sponsors for Alectinib Hydrochloride

Sponsor Name

Sponsor Name for Alectinib Hydrochloride
Sponsor Trials
Hoffmann-La Roche 22
Genentech, Inc. 8
Ariad Pharmaceuticals 3
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Sponsor Type

Sponsor Type for Alectinib Hydrochloride
Sponsor Trials
Other 64
Industry 62
NIH 1
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