Lenvatinib

Generic Name
Lenvatinib
Brand Names
Lenvima 10, Kisplyx, Lenvima
Drug Type
Small Molecule
Chemical Formula
C21H19ClN4O4
CAS Number
417716-92-8
Unique Ingredient Identifier
EE083865G2
Background

Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. These receptor tyrosine kinases (RTKs) located in the cell membrane play a central role in the activation of signal transduction pathways involved in the normal regulation of cellular processes, such as cell proliferation, migration, apoptosis and differentiation, and in pathogenic angiogenesis, lymphogenesis, tumour growth and cancer progression. In particular, VEGF has been identified as a crucial regulator of both physiologic and pathologic angiogenesis and increased expression of VEGF is associated with a poor prognosis in many types of cancers.

Lenvatinib is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer. Most patients with thyroid cancer have a very good prognosis with treatment (98% 5 year survival rate) involving surgery and hormone therapy. However, for patients with RAI-refractory thyroid cancer, treatment options are limited and the prognosis is poor, leading to a push for the development of more targeted therapies such as lenvatinib.

Indication

Lenvatinib is indicated for the treatment of the following cancerous conditions:

Differentiated Thyroid Cancer (DTC)

Renal Cell Carcinoma (RCC)

Hepatocellular Carcinoma (HCC)

Endometrial Carcinoma

Associated Conditions
Advanced Renal Cell Carcinoma, Endometrial Carcinoma, Unresectable Hepatocellular Carcinoma (HCC), Progressive, locally advanced radioactive iodine-refractory Differentiated Thyroid Cancer (DTC), Progressive, metastatic radioactive iodine-refractory Differentiated Thyroid Cancer (DTC)
Associated Therapies
-

Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma

First Posted Date
2020-05-26
Last Posted Date
2024-10-26
Lead Sponsor
BeiGene
Target Recruit Count
64
Registration Number
NCT04401800
Locations
🇨🇳

Sun Yat Sen University Cancer Center, Guangzhou, Guangdong, China

🇨🇳

Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, China

🇨🇳

The First Affiliated Hospital of Xian Jiaotong University, Xian, Shaanxi, China

and more 6 locations

Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma

First Posted Date
2020-05-19
Last Posted Date
2024-08-14
Lead Sponsor
Emory University
Target Recruit Count
22
Registration Number
NCT04393350
Locations
🇺🇸

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

Lenvatinib in Locally Advanced Invasive Thyroid Cancer

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2020-03-25
Last Posted Date
2023-11-03
Lead Sponsor
Massachusetts Eye and Ear Infirmary
Target Recruit Count
30
Registration Number
NCT04321954
Locations
🇺🇸

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

🇺🇸

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

Lenvatinib Following Liver Transplantation in Patients of Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

First Posted Date
2020-03-24
Last Posted Date
2020-03-24
Lead Sponsor
RenJi Hospital
Target Recruit Count
108
Registration Number
NCT04319484

Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)

First Posted Date
2020-03-12
Last Posted Date
2024-12-06
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
315
Registration Number
NCT04305054
Locations
🇺🇸

The Angeles Clinic and Research Institute ( Site 2009), Los Angeles, California, United States

🇺🇸

UCLA Hematology & Oncology ( Site 2004), Los Angeles, California, United States

🇺🇸

Providence Saint John's Health Center ( Site 2010), Santa Monica, California, United States

and more 57 locations

Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)

First Posted Date
2020-03-12
Last Posted Date
2024-11-19
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
200
Registration Number
NCT04305041
Locations
🇮🇱

Chaim Sheba Medical Center ( Site 1701), Ramat Gan, Israel

🇫🇷

A.P.H. Paris, Hopital Saint Louis ( Site 1107), Paris, France

🇫🇷

Hopital Saint Andre ( Site 1108), Bordeaux, Gironde, France

and more 32 locations

A Study to Assess the Safety and Efficacy of Lenvatinib as First-line Treatment in Participants With Unresectable HCC

Phase 4
Completed
Conditions
Interventions
First Posted Date
2020-03-05
Last Posted Date
2023-11-15
Lead Sponsor
Eisai Pharmaceuticals India Pvt. Ltd
Target Recruit Count
50
Registration Number
NCT04297254
Locations
🇮🇳

LMMF's Deenanath Mangeshkar Hospital & Research Center, Pune, Maharashtra, India

🇮🇳

Shatabdi Hospital, Nashik, Maharashtra, India

🇮🇳

Somani Hospital, Jaipur, Rajasthan, India

and more 7 locations

Pembrolizumab Plus Lenvatinib In Second Line and Third Line Malignant Pleural mesotheLioma Patients

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-02-27
Last Posted Date
2024-11-05
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
58
Registration Number
NCT04287829
Locations
🇳🇱

Antoni van Leeuwenhoekziekenhuis (NKI-AVL), Amsterdam, Noord-Holland, Netherlands

Lenvatinib (LEN) in Combination With Pembrolizumab (KEYtruda) in Subjects With Locally Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma (The LENKYN Trial)

First Posted Date
2020-02-12
Last Posted Date
2024-11-26
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
11
Registration Number
NCT04267120
Locations
🇺🇸

Stanford Cancer Center, Palo Alto, California, United States

🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

First Posted Date
2020-01-29
Last Posted Date
2024-11-18
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
450
Registration Number
NCT04246177
Locations
🇺🇸

University of Cincinnati Medical Center ( Site 0791), Cincinnati, Ohio, United States

🇺🇸

The Ohio State University Wexner Medical Center ( Site 0759), Columbus, Ohio, United States

🇨🇳

Anhui Provincial Hospital ( Site 0092), Heifei, Anhui, China

and more 204 locations
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