Cabozantinib

Generic Name: Cabozantinib

Brand Names: Cabometyx, Cometriq

Drug Type: Small Molecule

Chemical Formula: C_₂₈H_₂₄FN_₃O_₅

CAS Number: 849217-68-1

Unique Ingredient Identifier: 1C39JW444G

Background: Cabozantinib was first approved in 2012 and is a non-specific tyrosine kinase inhibitor. It was initially approved in the US under the brand name Cometriq, which is indicated for the treatment of metastatic medullary thyroid cancer. In 2016, a capsule formulation (Cabometyx) was approved for the treatment of advanced renal cell carcinoma, and this same formulation gained additional approval in both the US and Canada in 2019 for the treatment of hepatocellular carcinoma in previously treated patients.

Indication: ⑴治疗进展的、不能切除的局部晚期或转移的髓性甲状腺癌。

⑵用于舒尼替尼（索坦）治疗失败的晚期肾癌。

Associated Conditions: Advanced Renal Cell Carcinoma, Hepatocellular Carcinoma, Metastatic Differentiated Thyroid Cancer, Locally advanced Differentiated Thyroid Cancer (DTC), Metastatic Clear Cell Renal Cell Carcinoma (ccRCC), Progressive, metastatic Medullary thyroid cancer

Associated Therapies: -

Clinical Trials

Adaptive Tyrosine Kinase Inhibitor (TKI) Therapy In Patients With Thyroid Cancer

Phase 2

Terminated

Conditions: Thyroid Cancer
Papillary Thyroid Cancer
Follicular Thyroid Cancer
Thyroid Cancer, Medullary
Differentiated Thyroid Cancer
Poorly Differentiated Thyroid Gland Carcinoma

Interventions: Drug: Lenvatinib
Drug: Cabozantinib
Drug: Sorafenib
Drug: Vandetanib

First Posted Date: 2018-08-14

Last Posted Date: 2021-07-14

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 6

Registration Number: NCT03630120

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Cabozantinib in Combination With 13-cis-Retinoic Acid in Children With Relapsed or Refractory Solid Tumors

Phase 1

Recruiting

Conditions: Solid Tumor

Interventions: Drug: Cabozantinib
Drug: 13-cis-retinoic acid

First Posted Date: 2018-08-02

Last Posted Date: 2024-08-05

Lead Sponsor: Peter Zage

Target Recruit Count: 18

Registration Number: NCT03611595

Locations: 🇺🇸
Rady Children's Hospital - San Diego, San Diego, California, United States
🇺🇸
Children's Healthcare of Atlanta, Atlanta, Georgia, United States

A Phase 2 Study of Cabozantinib in Japanese Participants With Advanced Hepatocellular Carcinoma

Phase 2

Completed

Conditions: Advanced Hepatocellular Carcinoma

Interventions: Drug: Cabozantinib

First Posted Date: 2018-07-16

Last Posted Date: 2023-04-18

Lead Sponsor: Takeda

Target Recruit Count: 34

Registration Number: NCT03586973

Locations: 🇯🇵
Hiroshima University Hospital, Hiroshima, Japan
🇯🇵
Okayama University Hospital, Okayama, Japan
🇯🇵
Yokohama City University Medical Center, Yokohama, Kanagawa, Japan

and more 14 locations

Cabozantinib or Sunitinib Malate in Treating Participants With Metastatic Variant Histology Renal Cell Carcinoma

Phase 2

Active, not recruiting

Conditions: Malignant Neoplasms of Urinary Tract
Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions
Stage IV Renal Cell Cancer AJCC v8
Unclassified Renal Cell Carcinoma
Chromophobe Renal Cell Carcinoma
Papillary Renal Cell Carcinoma
Sarcomatoid Renal Cell Carcinoma

Interventions: Drug: Cabozantinib
Drug: Sunitinib Malate

First Posted Date: 2018-05-31

Last Posted Date: 2025-01-09

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 32

Registration Number: NCT03541902

Locations: 🇺🇸
MD Anderson Regional Care Center-Sugar Land, Sugar Land, Texas, United States
🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸
MD Anderson Regional Care Center-Katy, Houston, Texas, United States

Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies

Phase 1

Active, not recruiting

Conditions: Esophageal Adenocarcinoma
Gastric Cancer
Hepatocellular Carcinoma
Colorectal Cancer

Interventions: Drug: Cabozantinib
Drug: Durvalumab
Drug: Tremelimumab

First Posted Date: 2018-05-29

Last Posted Date: 2024-06-07

Lead Sponsor: Anwaar Saeed

Target Recruit Count: 117

Registration Number: NCT03539822

Locations: 🇺🇸
University of Kansas Cancer Center, Westwood, Kansas, United States
🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma

Phase 2

Completed

Conditions: Bladder Cancer
Metastatic Urothelial Carcinoma

Interventions: Drug: Cabozantinib
Drug: Pembrolizumab

First Posted Date: 2018-05-23

Last Posted Date: 2024-11-26

Lead Sponsor: University of Utah

Target Recruit Count: 37

Registration Number: NCT03534804

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States
🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States

Nivolumab, Cabozantinib S-Malate, and Ipilimumab in Treating Patients With Recurrent Stage IV Non-small Cell Lung Cancer

Phase 2

Completed

Conditions: Recurrent Lung Non-Squamous Non-Small Cell Carcinoma
Metastatic Lung Non-Squamous Non-Small Cell Carcinoma
Stage IV Lung Non-Small Cell Cancer AJCC v7

Interventions: Biological: Nivolumab
Drug: Cabozantinib
Biological: Ipilimumab

First Posted Date: 2018-03-19

Last Posted Date: 2023-10-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 3

Registration Number: NCT03468985

Locations: 🇺🇸
Riverside Methodist Hospital, Columbus, Ohio, United States
🇺🇸
Grant Medical Center, Columbus, Ohio, United States
🇺🇸
The Mark H Zangmeister Center, Columbus, Ohio, United States

and more 465 locations

Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Head and Neck Carcinoma
Paranasal Sinus Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Oral Cavity Squamous Cell Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7

Interventions: Drug: Cabozantinib
Biological: Pembrolizumab

First Posted Date: 2018-03-16

Last Posted Date: 2024-12-27

Lead Sponsor: Emory University

Target Recruit Count: 36

Registration Number: NCT03468218

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Emory University Hospital Midtown, Atlanta, Georgia, United States

CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma

Phase 2

Completed

Conditions: Advanced Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma

Interventions: Drug: CB-839
Drug: Cabozantinib
Drug: Placebo

First Posted Date: 2018-02-09

Last Posted Date: 2023-03-20

Lead Sponsor: Calithera Biosciences, Inc

Target Recruit Count: 444

Registration Number: NCT03428217

Locations: 🇺🇸
NorthShore University HealthSystem, Evanston, Illinois, United States
🇺🇸
Orchard Healthcare Research, Inc., Skokie, Illinois, United States
🇺🇸
University of Maryland, Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States

and more 129 locations

Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

Phase 3

Active, not recruiting

Conditions: Carcinoid Tumor
Functioning Pancreatic Neuroendocrine Tumor
Intermediate Grade Lung Neuroendocrine Neoplasm
Locally Advanced Digestive System Neuroendocrine Neoplasm
Locally Advanced Digestive System Neuroendocrine Tumor G1
Locally Advanced Lung Neuroendocrine Neoplasm
Locally Advanced Pancreatic Neuroendocrine Tumor
Locally Advanced Unresectable Digestive System Neuroendocrine Neoplasm
Low Grade Lung Neuroendocrine Neoplasm
Lung Neuroendocrine Tumor

Interventions: Drug: Cabozantinib S-malate
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Other: Placebo Administration
Other: Quality-of-Life Assessment
Procedure: X-Ray Imaging

First Posted Date: 2017-12-18

Last Posted Date: 2024-12-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 298

Registration Number: NCT03375320

Locations: 🇺🇸
Henry Ford River District Hospital, East China Township, Michigan, United States
🇺🇸
Henry Ford Saint John Hospital - Macomb Medical, Macomb, Michigan, United States
🇺🇸
Henry Ford Health Warren Hospital, Warren, Michigan, United States

and more 432 locations

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