Alectinib

Generic Name: Alectinib

Brand Names: Alecensa, Alecensaro

Drug Type: Small Molecule

Chemical Formula: C_₃₀H_₃₄N_₄O_₂

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

Clinical Trials

A Study of the Efficacy and Safety of Alectinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer

Phase 2

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Alectinib

First Posted Date: 2017-05-16

Last Posted Date: 2020-02-10

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 44

Registration Number: NCT03155009

Locations: 🇫🇷
CHU Angers, Angers, France
🇫🇷
Hopital Augustin Morvan; Oncologie Thoracique, Brest, France
🇫🇷
Hopital Jean Minjoz; Pneumologie, Besancon, France

and more 13 locations

A Study of Alectinib in RET-rearranged Non-small Cell Lung Cancer or RET-mutated Thyroid Cancer

Phase 1

Terminated

Conditions: ALK-positive Non-small Cell Lung Cancer (NSCLC)
RET-positive Non-small Cell Lung Cancer (NSCLC)
RET-positive Thyroid Cancer

Interventions: Drug: Alectinib

First Posted Date: 2017-04-27

Last Posted Date: 2021-09-27

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 5

Registration Number: NCT03131206

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

and more 1 locations

The Drug Rediscovery Protocol (DRUP Trial)

First Posted Date: 2016-10-05

Last Posted Date: 2024-01-24

Lead Sponsor: The Netherlands Cancer Institute

Target Recruit Count: 1550

Registration Number: NCT02925234

Locations: 🇳🇱
Meander medisch centrum, Amersfoort, Netherlands
🇳🇱
Netherlands Cancer Institute, Amsterdam, Netherlands
🇳🇱
Amsterdam UMC, locatie AMC, Amsterdam, Netherlands

and more 33 locations

A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 3

Active, not recruiting

Conditions: Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer

Interventions: Drug: Alectinib
Drug: Crizotinib

First Posted Date: 2016-07-20

Last Posted Date: 2025-03-25

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 187

Registration Number: NCT02838420

Locations: 🇨🇳
Beijing Cancer Hospital, Beijing, China
🇨🇳
Guangdong General Hospital, Guangzhou, China
🇨🇳
Shanghai chest hospital, Shanghai, China

and more 19 locations

Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib

Phase 1

Completed

Conditions: Hepatic Impairment

Interventions: Drug: Alectinib

First Posted Date: 2015-12-03

Last Posted Date: 2018-08-24

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 28

Registration Number: NCT02621047

Locations: 🇸🇰
Summit Clinical Research s.r.o.; Oddelenie internej mediciny a klinickej farmakologie, Bratislava, Slovakia
🇨🇿
Pharmaceutical Research Associates CZ, s.r.o., Praha 7, Czechia

Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib

Phase 3

Completed

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Alectinib
Drug: Docetaxel
Drug: Pemetrexed

First Posted Date: 2015-11-13

Last Posted Date: 2019-10-29

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 119

Registration Number: NCT02604342

Locations: 🇮🇹
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica, Perugia, Umbria, Italy
🇵🇱
Medical University of Gdansk, Gdansk, Poland
🇮🇹
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1, Roma, Lazio, Italy

and more 51 locations

Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer

Phase 1

Terminated

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Interventions: Drug: Alectinib
Drug: Bevacizumab

First Posted Date: 2015-08-13

Last Posted Date: 2025-05-13

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 11

Registration Number: NCT02521051

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity

Phase 2

Active, not recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: MPDL3280A
Drug: Vemurafenib
Drug: Alectinib
Drug: Trastuzumab emtansine

First Posted Date: 2014-12-11

Last Posted Date: 2023-12-04

Lead Sponsor: University College, London

Target Recruit Count: 50

Registration Number: NCT02314481

Locations: 🇬🇧
Univeristy College London Hospital, London, United Kingdom

Expanded Access Study of Alectinib for Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy

Conditions: Non-Small Cell Lung Cancer

First Posted Date: 2014-10-22

Last Posted Date: 2017-03-09

Lead Sponsor: Genentech, Inc.

Registration Number: NCT02271139

Locations: 🇺🇸
LAC USC Medical Center, Los Angeles, California, United States
🇺🇸
University of Southern California, Los Angeles, California, United States
🇺🇸
Allegheny Cancer Center, Pittsburgh, Pennsylvania, United States

and more 41 locations

My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors

Phase 2

Completed

Conditions: Bladder Cancer
Neoplasms
Solid Tumors
Biliary Cancer
Salivary Cancer

Interventions: Drug: Atezolizumab
Drug: Trastuzumab
Drug: Vemurafenib
Drug: Vismodegib
Drug: Alectinib
Drug: Erlotinib
Drug: Pertuzumab
Drug: Cobimetinib

First Posted Date: 2014-03-19

Last Posted Date: 2024-07-23

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 673

Registration Number: NCT02091141

Locations: 🇺🇸
University Of Chicago Medical Center; Section Of Hematology/Oncology, Chicago, Illinois, United States
🇺🇸
MD Anderson, Houston, Texas, United States
🇺🇸
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

and more 57 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy