MedPath

Alectinib

Generic Name
Alectinib
Brand Names
Alecensa, Alecensaro
Drug Type
Small Molecule
Chemical Formula
C30H34N4O2
CAS Number
1256580-46-7
Unique Ingredient Identifier
LIJ4CT1Z3Y
Background

Alectinib is a second generation oral drug that selectively inhibits the activity of anaplastic lymphoma kinase (ALK) tyrosine kinase. It is specifically used in the treatment of non-small cell lung cancer (NSCLC) expressing the ALK-EML4 (echinoderm microtubule-associated protein-like 4) fusion protein that causes proliferation of NSCLC cells. Inhibition of ALK prevents phosphorylation and subsequent downstream activation of STAT3 and AKT resulting in reduced tumour cell viability.

Approved under accelerated approval in 2015, alectinib is indicated for use in patients who have progressed on or were not tolerant of crizotinib, which is associated with the development of resistance.

Indication

Alectinib is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Associated Conditions
Refractory, metastatic Non small cell lung cancer

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants

Phase 3
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2014-03-03
Last Posted Date
2025-05-11
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
303
Registration Number
NCT02075840
Locations
🇺🇦

Kyiv Regional Oncological Dispensary, Kyiv, Ukraine

🇨🇳

Sun Yet-sen University Cancer Center, Guangzhou, China

🇫🇷

Chu Grenoble - Hopital Albert Michallon, Grenoble, France

and more 95 locations

A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers.

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
Other: High Fat and Calorie Meal
Other: Standard Meal
First Posted Date
2013-12-30
Last Posted Date
2016-10-07
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
42
Registration Number
NCT02023125

A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer (NSCLC)

Phase 1
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2013-12-17
Last Posted Date
2020-04-21
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
52
Registration Number
NCT02013219
Locations
🇺🇸

Yale University School Of Medicine, New Haven, Connecticut, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇭🇰

The Chinese University of Hong Kong, Shatin, Hong Kong

and more 14 locations

A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
First Posted Date
2013-11-14
Last Posted Date
2016-10-11
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
23
Registration Number
NCT01984229

A Study of the Elimination, Pharmacokinetics, and Metabolism of RO5424802

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
First Posted Date
2013-11-11
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
6
Registration Number
NCT01981005

A Study of the Effect of Multiple Doses of Rifampin on the Single Dose Pharmacokinetics of RO5424802

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
First Posted Date
2013-09-12
Last Posted Date
2016-12-21
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
24
Registration Number
NCT01940510

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)

Phase 1
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2013-06-07
Last Posted Date
2018-08-21
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
134
Registration Number
NCT01871805
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, Commack, New York, United States

🇺🇸

UCSD Moores Cancer Center, La Jolla, California, United States

🇺🇸

UCLA, Los Angeles, California, United States

and more 39 locations

A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment

Phase 1
Completed
Conditions
Non-Small-Cell Lung Carcinoma
Interventions
First Posted Date
2013-02-28
Last Posted Date
2018-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
138
Registration Number
NCT01801111
Locations
🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

🇺🇸

UCLA Cancer Center; Premiere Oncology, A Medical Corporation, Santa Monica, California, United States

🇺🇸

Washington University; Wash Uni. Sch. Of Med, Saint Louis, Missouri, United States

and more 81 locations
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