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 to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- First Posted Date
- 2023-04-28
- Last Posted Date
- 2025-03-30
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 5279
- Registration Number
- NCT05834348
- Locations
- 🇳🇴
Pfizer Norway, Oslo, Norway
DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers
- Conditions
- Haematological MalignancyMalignant NeoplasmLymphoproliferative DisordersNeoplasms by Histologic TypeNeoplasms by SiteCancerAnaplastic Large Cell LymphomaLymphomaRenal Cell CarcinomaNeuroblastoma
- Interventions
- First Posted Date
- 2023-03-15
- Last Posted Date
- 2025-05-20
- Lead Sponsor
- Cancer Research UK
- Target Recruit Count
- 30
- Registration Number
- NCT05770037
- Locations
- 🇬🇧
Belfast City Hospital, Belfast, United Kingdom
🇬🇧University Hospital Birmingham, Birmingham, United Kingdom
🇬🇧Birmingham Children's Hospital, Birmingham, United Kingdom
Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- First Posted Date
- 2023-02-13
- Last Posted Date
- 2023-02-21
- Lead Sponsor
- Oslo University Hospital
- Target Recruit Count
- 40
- Registration Number
- NCT05725200
- Locations
- 🇳🇴
Oslo University Hospital, Oslo, Norway
DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol
- Conditions
- Haematological MalignancySolid Tumor
- Interventions
- First Posted Date
- 2023-02-10
- Last Posted Date
- 2024-03-20
- Lead Sponsor
- Cancer Research UK
- Target Recruit Count
- 825
- Registration Number
- NCT05722886
- Locations
- 🇬🇧
Belfast City Hospital, Belfast, United Kingdom
🇬🇧Bristol Royal Hospital for Children, Bristol, United Kingdom
🇬🇧The Beatson Hospital, Glasgow, United Kingdom
Alectinib Pharmacokinetic in Patients With NSCLC
- Conditions
- Non-small Cell Lung Cancer Stage IIIBALK Gene Mutation
- Interventions
- First Posted Date
- 2023-02-06
- Last Posted Date
- 2025-05-01
- Lead Sponsor
- Instituto Nacional de Cancerologia de Mexico
- Target Recruit Count
- 45
- Registration Number
- NCT05713006
- Locations
- 🇲🇽
Thoracic Oncology Unit and Personalized Medicine Laboratory, Instituto Nacional de Cancerología, Mexico City, Mexico
KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
- Conditions
- Solid TumorAdvanced Solid TumorMetastatic Cancer
- Interventions
- First Posted Date
- 2022-09-02
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- Seoul National University Bundang Hospital
- Target Recruit Count
- 1000
- Registration Number
- NCT05525858
- Locations
- 🇰🇷
Soonchunhyang University Hospital Bucheon, Bucheon, Korea, Republic of
🇰🇷Chungbuk National University Hospital, Chungju, Korea, Republic of
🇰🇷Keimyung University Dongsan Hospital, Daegu, Korea, Republic of
Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels
- Conditions
- Drug MonitoringCarcinoma, Non-Small-Cell LungLung CancerAnaplastic Lymphoma Kinase Gene MutationAnaplastic Lymphoma Kinase Gene Translocation
- Interventions
- 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
SMMART Adaptive Clinical Treatment (ACT) Trial
- Conditions
- Advanced Breast CarcinomaAnatomic Stage IV Breast Cancer AJCC v8Stage II Pancreatic Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Advanced Prostate CarcinomaRecurrent Adult Soft Tissue SarcomaRecurrent Breast CarcinomaStage IV Ovarian Cancer AJCC v8Advanced Malignant Solid NeoplasmAdvanced Ovarian Carcinoma
- Interventions
- Biological: AtezolizumabBiological: BevacizumabProcedure: BiopsyProcedure: Biospecimen CollectionBiological: Hyaluronidase-zzxf/Pertuzumab/TrastuzumabBiological: PertuzumabOther: Quality-of-Life AssessmentBiological: TrastuzumabBiological: Trastuzumab Emtansine
- 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)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- First Posted Date
- 2021-12-27
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 121
- Registration Number
- NCT05170204
- Locations
- 🇨🇷
Clinica CIMCA, San Jose, Costa Rica
🇮🇱Rambam Medical Center, Haifa, Israel
🇯🇵Shikoku Cancer Center, Ehime, Japan
The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs
- Conditions
- Advanced CancerSolid TumorHaematological Malignancy
- Interventions
- Drug: Trastuzumab+PertuzumabDrug: Dabrafenib+Trametinib
- 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
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.