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Generated: February 22, 2019

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CLINICAL TRIALS PROFILE FOR ALECTINIB HYDROCHLORIDE

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Clinical Trials for Alectinib Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT01984229 A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers Completed Hoffmann-La Roche Phase 1 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 Recruiting Hoffmann-La Roche Phase 1 This open-label, multicenter study will assess the safety, tolerability, and pharmacokinetics of intravenous (IV) dosing of MPDL3280A (Atezolizumab) in combination with oral erlotinib or alectinib in participants with non-small cell lung cancer (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 (non-resectable) 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 treatment-naive participants with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. In Stage 1, erlotinib will be given at a starting dose of 150 milligrams (mg) once daily (QD) and the starting dose of alectinib will be 600 mg twice daily (BID), for 28 consecutive days during Cycle 1 and for 21-day cycles 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. Time on study is expected to be approximately 15 months.
NCT02023125 A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers. Completed Hoffmann-La Roche Phase 1 This two-group study will investigate the effect of food (Group 1) and esomeprazole (Group 2) on the single oral dose pharmacokinetics of alectinib in healthy volunteers. Participants in Group 1 will be randomly assigned to a two period treatment sequence (AB or BA) in which they will receive a single, oral dose of alectinib per period separated by at least 10 days. Each participant will receive single, oral doses alectinib given under fasted conditions (Treatment A) or following the ingestion of a high fat, high calorie meal (Treatment B) as determined by their assigned sequence. Participants in Group 2 will be given a single, oral dose of alectinib following a standard meal. After a washout period of at least 10 days, they will receive an oral dose of esomeprazole (40 mg) once daily for 6 days. On the 6th day of esomeprazole administration, a single, oral dose alectinib will be given after ingestion of a standard meal. In all groups, pharmacokinetics will be assessed in the 4 days following alectinib administration.
NCT02074553 A Study Examining the Bioequivalence of 3 Alectinib (RO5424802) Test Formulations to a Reference Formulation of in Healthy Participants Completed Hoffmann-La Roche Phase 1 This 2-part, single center, open-label, randomized, single-dose, 4-sequence, 4-period cross-over study will compare the bioequivalence of three test alectinib capsule formulations with the reference capsule formulation in healthy adult participants. All participants in both fasted (Part 1) and fed (Part 2) conditions of the study will receive each of 4 treatments: Treatment A (alectinib with 50 percent [%] sodium lauryl sulfate [SLS] [reference]), Treatment B (alectinib with 25% SLS [test]), Treatment C (alectinib with 12.5% SLS [test]), and Treatment D (alectinib with 3% SLS [test]) in a randomized sequence. Each treatment will be given as a single 600 milligrams (mg) oral administration in an upright position on Day 1 in a fed or fasted condition, followed by a 10-day washout period.
NCT02075840 ALEX Study: A Randomized, Phase III Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants Active, not recruiting Hoffmann-La Roche Phase 3 This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, consent withdrawal or death. The study is expected to last approximately 42 months.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Alectinib Hydrochloride

Condition Name

Condition Name for Alectinib Hydrochloride
Intervention Trials
Non-small Cell Lung Cancer 9
Healthy Volunteer 3
Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer 2
ALK-positive Advanced NSCLC 2
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Condition MeSH

Condition MeSH for Alectinib Hydrochloride
Intervention Trials
Carcinoma, Non-Small-Cell Lung 19
Lung Neoplasms 14
Lymphoma 3
Neoplasms, Unknown Primary 1
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Clinical Trial Locations for Alectinib Hydrochloride

Trials by Country

Trials by Country for Alectinib Hydrochloride
Location Trials
United States 73
Italy 46
Spain 18
Australia 17
France 14
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Trials by US State

Trials by US State for Alectinib Hydrochloride
Location Trials
Massachusetts 8
California 6
Michigan 5
Illinois 5
Texas 5
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Clinical Trial Progress for Alectinib Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Alectinib Hydrochloride
Clinical Trial Phase Trials
Phase 3 6
Phase 2/Phase 3 1
Phase 2 8
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Clinical Trial Status

Clinical Trial Status for Alectinib Hydrochloride
Clinical Trial Phase Trials
Not yet recruiting 12
Recruiting 10
Completed 4
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Clinical Trial Sponsors for Alectinib Hydrochloride

Sponsor Name

Sponsor Name for Alectinib Hydrochloride
Sponsor Trials
Hoffmann-La Roche 15
Genentech, Inc. 4
Ariad Pharmaceuticals 3
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Sponsor Type

Sponsor Type for Alectinib Hydrochloride
Sponsor Trials
Industry 26
Other 18
NIH 1
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