Sunitinib

Generic Name
Sunitinib
Brand Names
Sutent, Sunitinib Accord
Drug Type
Small Molecule
Chemical Formula
C22H27FN4O2
CAS Number
557795-19-4
Unique Ingredient Identifier
V99T50803M
Background

Sunitinib is a small-molecule multi-targeted receptor tyrosine kinase (RTK) inhibitor. On January 26, 2006, the agent was formally approved by the US FDA for the indications of treating renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GIST). For these purposes, sunitinib is generally available as an orally administered formulation. Sunitinib inhibits cellular signaling by targeting multiple RTKs. These include all platelet-derived growth factor receptors (PDGF-R) and vascular endothelial growth factor receptors (VEGF-R). Sunitinib also inhibits KIT (CD117), the RTK that drives the majority of GISTs. In addition, sunitinib inhibits other RTKs including RET, CSF-1R, and flt3.

Indication

Sunitinib is indicated for the following conditions:

Associated Conditions
Gastrointestinal Stromal Tumor (GIST), Renal Cell Carcinoma (RCC), Renal Cell Carcinoma Recurrent, Unresectable, locally advanced Progressive Neuroendocrine Tumors of pancreatic origin, Unresectable, metastatic Progressive Neuroendocrine Tumors of pancreatic origin
Associated Therapies
-

OPALINE : A Study Of Morbidity And Mortality At 2 Years

First Posted Date
2014-10-15
Last Posted Date
2023-11-13
Lead Sponsor
Pfizer
Target Recruit Count
144
Registration Number
NCT02264665
Locations
🇫🇷

Groupe Hospitalier Cochin, Paris Cedex, France

🇫🇷

CHU de Strasbourg - Hopital de Hautepierre / Service de Medecine Interne et Nutrition, Strasbourg Cedex, France

🇫🇷

Hopital Foch, Onco Hermatologie, Suresnes cedex, France

and more 31 locations

HGG-TCP (High Grade Glioma - Tumor Concentrations of Protein Kinase Inhibitors)

First Posted Date
2014-09-15
Last Posted Date
2020-10-08
Lead Sponsor
Amsterdam UMC, location VUmc
Target Recruit Count
15
Registration Number
NCT02239952
Locations
🇳🇱

VU University Medical Center, Amsterdam, Noord-Holland, Netherlands

Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

First Posted Date
2014-09-04
Last Posted Date
2023-11-15
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
1390
Registration Number
NCT02231749
Locations
🇮🇱

Local Institution - 0120, Haifa, Israel

🇺🇸

Local Institution - 0057, La Jolla, California, United States

🇺🇸

Local Institution - 0067, Stanford, California, United States

and more 186 locations

Phase Ib Study of SUnitinib Alternating With REgorafenib in Patients With Metastatic and/or Unresectable GIST

First Posted Date
2014-06-16
Last Posted Date
2021-06-14
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
14
Registration Number
NCT02164240
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Phase II Study of Sunitinib Rechallenge in Patients With Metastatic Renal Cell Carcinoma

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2014-02-26
Last Posted Date
2017-04-07
Lead Sponsor
Amsterdam UMC, location VUmc
Target Recruit Count
5
Registration Number
NCT02071641
Locations
🇳🇱

VU Medical Center, Amsterdam, Netherlands

Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)

First Posted Date
2014-02-12
Last Posted Date
2020-02-27
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
60
Registration Number
NCT02060370
Locations
🇺🇸

Stanford University Medical Center, Stanford, California, United States

🇺🇸

Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, United States

🇺🇸

Lineberger Cancer Center, Chapel Hill, North Carolina, United States

and more 2 locations

Study of High-dose, Intermittent Sunitinib in Patients With Solid Tumors.

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-02-10
Last Posted Date
2019-07-17
Lead Sponsor
Amsterdam UMC, location VUmc
Target Recruit Count
101
Registration Number
NCT02058901
Locations
🇳🇱

VU University Medical Center, Amsterdam, Netherlands

A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) as Monotherapy or in Combination With Bevacizumab (Avastin®) Compared to Sunitinib (Sutent®) in Participants With Untreated Advanced Renal Cell Carcinoma

First Posted Date
2013-11-14
Last Posted Date
2019-12-23
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
305
Registration Number
NCT01984242
Locations
🇺🇸

The University of Chicago, Chicago, Illinois, United States

🇺🇸

Texas Oncology-Baylor Sammons Cancer Center, Dallas, Texas, United States

🇺🇸

University of California, San Francisco, California, United States

and more 42 locations
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