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

Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study

Phase 3

Active, not recruiting

Conditions: Clear Cell Renal Cell Carcinoma
Metastatic Malignant Neoplasm in the Bone
Metastatic Malignant Neoplasm in the Lymph Nodes
Metastatic Malignant Neoplasm in the Soft Tissues
Metastatic Malignant Neoplasm in the Viscera
Rhabdoid Tumor of the Kidney
Sarcomatoid Renal Cell Carcinoma
Stage III Renal Cell Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Scan
Drug: Cabozantinib
Procedure: Computed Tomography
Biological: Ipilimumab
Procedure: Magnetic Resonance Imaging
Biological: Nivolumab
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

First Posted Date: 2019-01-04

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1175

Registration Number: NCT03793166

Locations: 🇺🇸
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
🇺🇸
Sidney and Lois Eskenazi Hospital, Indianapolis, Indiana, United States
🇺🇸
Franciscan Health Indianapolis, Indianapolis, Indiana, United States

and more 862 locations

A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

Phase 3

Recruiting

Conditions: Cancer

Interventions: Drug: Atezolizumab
Drug: Cobimetinib
Drug: Bevacizumab
Drug: Vemurafenib
Drug: Alectinib
Drug: Pembrolizumab
Drug: FAP IL2V
Drug: Sunitinib
Drug: Venetoclax
Drug: Enzalutamide
Drug: Paclitaxel
Drug: Niraparib
Drug: Cabozantinib
Drug: Pemetrexed
Drug: Emactuzumab
Drug: Rucaparib

First Posted Date: 2018-12-07

Last Posted Date: 2024-12-20

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 1000

Registration Number: NCT03768063

Locations: 🇺🇸
Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr, Birmingham, Alabama, United States
🇺🇸
HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network, Scottsdale, Arizona, United States
🇺🇸
University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute, Little Rock, Arkansas, United States

and more 199 locations

Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy

Phase 3

Active, not recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Cabozantinib
Drug: Sorafenib
Drug: Atezolizumab

First Posted Date: 2018-11-28

Last Posted Date: 2024-03-22

Lead Sponsor: Exelixis

Target Recruit Count: 837

Registration Number: NCT03755791

Locations: 🇺🇸
Exelixis Clinical Site #88, Philadelphia, Pennsylvania, United States
🇦🇺
Exelixis Clinical Site #78, Camperdown, New South Wales, Australia
🇺🇸
Exelixis Clinical Site #7, Burlington, Massachusetts, United States

and more 242 locations

A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)

Phase 3

Terminated

Conditions: Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma

Interventions: Biological: bempegaldesleukin
Drug: sunitinib
Biological: nivolumab
Drug: cabozantinib

First Posted Date: 2018-11-02

Last Posted Date: 2023-04-11

Lead Sponsor: Nektar Therapeutics

Target Recruit Count: 623

Registration Number: NCT03729245

Locations: 🇺🇸
Alaska Urological, Anchorage, Alaska, United States
🇺🇸
CARTI Cancer Center, Little Rock, Arkansas, United States
🇦🇷
Centro de Investigación Pergamino S.A, Buenos Aires, Argentina

and more 92 locations

Cabozantinib in Advanced Salivary Gland Cancer Patients

Phase 2

Terminated

Conditions: Salivary Gland Cancer

Interventions: Drug: Cabozantinib

First Posted Date: 2018-11-02

Last Posted Date: 2021-03-12

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 25

Registration Number: NCT03729297

Locations: 🇳🇱
Radboudumc, Nijmegen, Gelderland, Netherlands

A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

Phase 3

Active, not recruiting

Conditions: Differentiated Thyroid Cancer

Interventions: Drug: Cabozantinib
Drug: Placebo

First Posted Date: 2018-10-01

Last Posted Date: 2024-03-22

Lead Sponsor: Exelixis

Target Recruit Count: 187

Registration Number: NCT03690388

Locations: 🇺🇸
Exelixis Clinical Site #2, Newport Beach, California, United States
🇺🇸
Exelixis Clinical Site #153, Boston, Massachusetts, United States
🇺🇸
Exelixis Clinical Site #75, Pittsburgh, Pennsylvania, United States

and more 161 locations

ANZUP - Non-clear Cell Post Immunotherapy CABozantinib (UNICAB)

Phase 2

Conditions: Renal Cell Carcinoma
Papillary Renal Cell Carcinoma Type 2
Papillary Renal Cell Carcinoma Type 1
Chromophobe Renal Cell Carcinoma
Sarcomatoid Renal Cell Carcinoma
Xp11.2 Translocation-Related Renal Cell Carcinoma

Interventions: Drug: Cabozantinib

First Posted Date: 2018-09-26

Last Posted Date: 2022-02-16

Lead Sponsor: Australian and New Zealand Urogenital and Prostate Cancer Trials Group

Target Recruit Count: 48

Registration Number: NCT03685448

Locations: 🇦🇺
Campbelltown Hospital, Campbelltown, New South Wales, Australia
🇦🇺
Box Hill Hospital - Eastern Health, Box Hill, Victoria, Australia
🇦🇺
Flinders Medical Centre, Bedford Park, South Australia, Australia

and more 8 locations

Cabozantinib in Combination With Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer

Phase 1

Completed

Conditions: Head and Neck Squamous Cell Cancer
Recurrent Head and Neck Squamous Cell Cancer
Metastatic Head and Neck Squamous Cell Cancer

Interventions: Drug: Cabozantinib
Drug: Cetuximab

First Posted Date: 2018-09-12

Last Posted Date: 2024-07-23

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 20

Registration Number: NCT03667482

Locations: 🇺🇸
Baptist Alliance MCI, Miami, Florida, United States
🇺🇸
Lehigh Valley Health Network, Allentown, Pennsylvania, United States
🇺🇸
Memorial Sloan Kettering Nassau, Uniondale, New York, United States

and more 6 locations

A Study of Nivolumab In Combination With Cabozantinib in Patients With Non-Clear Cell Renal Cell Carcinoma

Phase 2

Active, not recruiting

Conditions: Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma
Unclassified Renal Cell Carcinoma
Papillary Renal Cell Carcinoma
Fumarate Hydratase Deficient Renal Cell Carcinoma
Succinate Dehydrogenase Deficient Renal Cell Carcinoma
Collecting Duct Renal Cell Carcinoma
Chromophobe Renal Cell Carcinoma

Interventions: Drug: cabozantinib
Drug: nivolumab

First Posted Date: 2018-08-17

Last Posted Date: 2024-05-22

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 60

Registration Number: NCT03635892

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Commack, Commack, New York, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

and more 4 locations

A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)

Phase 2

Active, not recruiting

Conditions: Renal Cell Carcinoma (RCC)
Clear Cell Renal Cell Carcinoma (ccRCC)
Kidney Cancer
Renal Cancer
Renal Cell Carcinoma
Renal Cell Cancer Metastatic
Renal Cell Carcinoma Recurrent
Renal Cell Cancer, Recurrent
Kidney

Interventions: Drug: Belzutifan
Drug: Cabozantinib

First Posted Date: 2018-08-16

Last Posted Date: 2024-12-20

Lead Sponsor: Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Target Recruit Count: 118

Registration Number: NCT03634540

Locations: 🇺🇸
Tennessee Oncology, PLLC ( Site 0024), Chattanooga, Tennessee, United States
🇺🇸
Swedish Cancer Institute ( Site 0018), Seattle, Washington, United States
🇺🇸
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0035), Seattle, Washington, United States

and more 7 locations

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