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 ...

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 ...

Associated Conditions: Refractory, metastatic Non small cell lung cancer

Associated Therapies: -

Clinical Trials

Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels

Phase 4

Recruiting

Conditions: Drug Monitoring
Carcinoma, Non-Small-Cell Lung
Lung Cancer
Anaplastic Lymphoma Kinase Gene Mutation
Anaplastic Lymphoma Kinase Gene Translocation

Interventions: Drug: Alectinib

First Posted Date: 2022-09-01

Last Posted Date: 2024-05-13

Lead Sponsor: University Medical Center Groningen

Target Recruit Count: 196

Registration Number: NCT05525338

Locations: 🇳🇱
The Netherlands Cancer Institute, Amsterdam, Noord-Holland, Netherlands
🇳🇱
Leiden University Medical Center, Leiden, Zuid-Holland, Netherlands
🇳🇱
University Medical Center Groningen, Groningen, Netherlands

and more 5 locations

SMMART Adaptive Clinical Treatment (ACT) Trial

Early Phase 1

Withdrawn

Conditions: Advanced Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
Stage II Pancreatic Cancer AJCC v8
Stage III Ovarian Cancer AJCC v8
Advanced Prostate Carcinoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Breast Carcinoma
Stage IV Ovarian Cancer AJCC v8
Advanced Malignant Solid Neoplasm
Advanced Ovarian Carcinoma

First Posted Date: 2022-02-14

Last Posted Date: 2024-01-23

Lead Sponsor: OHSU Knight Cancer Institute

Registration Number: NCT05238831

A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)

Phase 3

Recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Durvalumab
Drug: Alectinib
Drug: Entrectinib

First Posted Date: 2021-12-27

Last Posted Date: 2024-11-26

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 121

Registration Number: NCT05170204

Locations: 🇮🇳
Medanta-The Medicity, Gurgaon, Haryana, India
🇹🇷
Dicle University Faculty of Medicine, Diyarbakir, Turkey
🇺🇸
University of South Alabama; Mitchell Cancer Institute, Mobile, Alabama, United States

and more 167 locations

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Phase 2

Recruiting

Conditions: Advanced Cancer
Solid Tumor
Haematological Malignancy

Interventions: Drug: Cobimetinib
Drug: Trastuzumab+Pertuzumab
Drug: Trametinib
Drug: Dabrafenib+Trametinib
Drug: Abemaciclib
Drug: Tepotinib
Drug: Dabrafenib
Drug: Pemigatinib
Drug: Regorafenib
Drug: Alectinib
Drug: Vismodegib
Drug: Entrectinib
Drug: Atezolizumab
Drug: Vemurafenib
Drug: Apalutamide

First Posted Date: 2021-12-16

Last Posted Date: 2024-07-15

Lead Sponsor: Helsinki University Central Hospital

Target Recruit Count: 250

Registration Number: NCT05159245

Locations: 🇫🇮
Turku University Hospital Cancer Centre, Turku, Varsinais-Suomi, Finland
🇫🇮
Kuopio University Hospital, Kuopio, Finland
🇫🇮
Oulu University Hospital OYS Cancer Center, Oulu, Finland

and more 2 locations

Brazilian Lung Immunotherapy Study

Phase 2

Completed

Conditions: Lung Neoplasm

Interventions: Drug: Alectinib
Drug: Nivolumab
Drug: Erlotinib
Drug: Pembrolizumab

First Posted Date: 2021-10-18

Last Posted Date: 2023-10-11

Lead Sponsor: Hospital Israelita Albert Einstein

Target Recruit Count: 154

Registration Number: NCT05081674

Locations: 🇧🇷
Hospital Municipal Vila Santa Catarina, São Paulo, Brazil

Alectinib in Neo-adjuvant Treatment of Stage III NSCLC

Phase 2

Active, not recruiting

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Alectinib

First Posted Date: 2021-08-20

Last Posted Date: 2024-08-09

Lead Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica

Target Recruit Count: 33

Registration Number: NCT05015010

Locations: 🇮🇹
UOC Oncologia Medica Ospedale Versilia USL Toscana Nord Ovest, Lido Di Camaiore, Lucca, Italy
🇮🇹
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - I.R.S.T., Meldola, Forlì-Cesena, Italy
🇮🇹
Centro di Riferimento Oncologico (CRO) - IRCCS Aviano, Aviano, Pordenone, Italy

and more 17 locations

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors

Phase 1

Recruiting

Conditions: ALK Fusion-positive Solid or CNS Tumors

Interventions: Drug: Alectinib

First Posted Date: 2021-03-01

Last Posted Date: 2024-12-03

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 42

Registration Number: NCT04774718

Locations: 🇮🇹
Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS, Genova, Liguria, Italy
🇮🇹
Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica, Milano, Lombardia, Italy
🇮🇹
Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita, Torino, Piemonte, Italy

and more 28 locations

An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib

Active, not recruiting

Conditions: NSCLC

Interventions: Drug: Alectinib

First Posted Date: 2021-02-21

Last Posted Date: 2024-10-24

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 800

Registration Number: NCT04764188

Locations: 🇨🇴
Instituto Cancerología Medellin, Medellin, Colombia
🇦🇷
Clinica Adventista Belgrano; Oncology, Ciudad Autonoma Buenos Aires, Argentina
🇦🇺
Lifehouse, Camperdown, New South Wales, Australia

and more 112 locations

Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients

Conditions: Mutation
Lung Cancer
ALK Gene Mutation
Resistance, Disease

First Posted Date: 2021-01-14

Last Posted Date: 2021-02-02

Lead Sponsor: Aarhus University Hospital

Target Recruit Count: 40

Registration Number: NCT04708639

Locations: 🇩🇰
Aarhus University Hospital, Aarhus, Denmark

Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers.

Completed

Conditions: ALK-positive NSCLC

Interventions: Drug: crizotinib
Drug: alectinib
Drug: brigatinib
Drug: ceritinib
Drug: lorlatinib

First Posted Date: 2020-11-30

Last Posted Date: 2023-04-06

Lead Sponsor: Pfizer

Target Recruit Count: 549

Registration Number: NCT04647110

Locations: 🇸🇪
Pfizer Innovations AB, Sollentuna, Sweden

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