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

CRAFT: The NCT-PMO-1602 Phase II Trial

First Posted Date
2020-09-16
Last Posted Date
2025-01-08
Lead Sponsor
German Cancer Research Center
Target Recruit Count
72
Registration Number
NCT04551521
Locations
🇩🇪

Charité - Universitätsmedizin Berlin, Berlin, Germany

🇩🇪

Nationales Centrum für Tumorerkrankungen (NCT), Heidelberg, Germany

🇩🇪

Universitätsklinikum Freiburg, Freiburg, Germany

and more 5 locations

Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns

Completed
Conditions
Non-Small-Cell Lung Carcinoma
Interventions
First Posted Date
2020-04-17
Last Posted Date
2023-03-27
Lead Sponsor
Pfizer
Target Recruit Count
1
Registration Number
NCT04351334
Locations
🇺🇸

Pfizer Inc, New York, New York, United States

ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling

First Posted Date
2020-04-10
Last Posted Date
2022-10-26
Lead Sponsor
Ulrik Lassen
Target Recruit Count
300
Registration Number
NCT04341181
Locations
🇩🇰

Aarhus University Hospital, Aarhus, Denmark

🇩🇰

Rigshospitalet, Copenhagen, Denmark

🇩🇰

Odense University Hospital, Odense, Denmark

and more 4 locations

Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation

Phase 2
Recruiting
Conditions
MET Gene Mutation
Non Small Cell Lung Cancer
ALK Gene Mutation
ROS1 Gene Mutation
EGFR Gene Mutation
Interventions
Drug: Savolitinib, Crizotinib.
Drug: Chemotherapy
First Posted Date
2020-03-26
Last Posted Date
2024-10-22
Lead Sponsor
Hunan Province Tumor Hospital
Target Recruit Count
6000
Registration Number
NCT04322890
Locations
🇨🇳

Yongchang Zhang, Changsha, Hunan, China

A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer

First Posted Date
2020-03-10
Last Posted Date
2025-05-18
Lead Sponsor
Genentech, Inc.
Target Recruit Count
125
Registration Number
NCT04302025
Locations
🇺🇸

University of California Los Angeles - Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

Ellis Fischel Cancer Center, Columbia, Missouri, United States

🇺🇸

UCSF Helen Diller Family CCC, San Francisco, California, United States

and more 35 locations

A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/characteristics in Advanced / Metastatic Tumors.

First Posted Date
2019-10-04
Last Posted Date
2024-12-12
Lead Sponsor
Centre Leon Berard
Target Recruit Count
455
Registration Number
NCT04116541
Locations
🇫🇷

Institut Bergonié, Bordeaux, France

🇫🇷

Centre Léon Bérard, Lyon, France

🇫🇷

Institut Paoli Calmettes, Marseille, France

and more 5 locations

Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)

First Posted Date
2019-05-10
Last Posted Date
2025-01-30
Lead Sponsor
AstraZeneca
Target Recruit Count
247
Registration Number
NCT03944772
Locations
🇸🇪

Research Site, Stockholm, Sweden

Alectinib in Combination With Bevacizumab in ALK Positive NSCLC

Phase 2
Completed
Conditions
Non-Squamous Non-Small Cell Neoplasm of Lung
ALK Gene Rearrangement Positive
Interventions
First Posted Date
2018-12-19
Last Posted Date
2023-07-06
Lead Sponsor
Instituto Nacional de Cancerologia de Mexico
Target Recruit Count
41
Registration Number
NCT03779191
Locations
🇲🇽

Instituto Nacional de Cancerologia, Mexico City, Mexico

A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

First Posted Date
2018-12-07
Last Posted Date
2025-05-04
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1000
Registration Number
NCT03768063
Locations
🇩🇪

Universitaets-Hautklinik Tuebingen, Tübingen, Germany

🇩🇪

Universitaettsklinikum Tübingen, Tübingen, Germany

🇩🇪

Universitätsklinik Tübingen, Tübingen, Germany

and more 83 locations
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