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
-

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

First Posted Date
2015-06-08
Last Posted Date
2024-12-19
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
6452
Registration Number
NCT02465060
Locations
🇺🇸

Alaska Women's Cancer Care, Anchorage, Alaska, United States

🇺🇸

Anchorage Oncology Centre, Anchorage, Alaska, United States

🇺🇸

Katmai Oncology Group, Anchorage, Alaska, United States

and more 1416 locations

Single-arm Study to Evaluate the Safety and Efficacy of Sunitinib, in Subjects With RET Fusion Positive or FGFR2 Amplification, Refractory Solid Tumors

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2015-05-21
Last Posted Date
2022-06-15
Lead Sponsor
Samsung Medical Center
Target Recruit Count
1
Registration Number
NCT02450123
Locations
🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

Isoquercetin as an Adjunct Therapy in Patients With Kidney Cancer Receiving First-line Sunitinib: a Phase I/II Trial

First Posted Date
2015-05-18
Last Posted Date
2017-01-18
Lead Sponsor
Consorzio Oncotech
Target Recruit Count
104
Registration Number
NCT02446795
Locations
🇮🇹

Ospedale Oncologico Regionale - Centro di Riferimento Oncologico di Basilicata U.O. di Oncologia Medica, Rionero in vulture, Potenza, Italy

🇮🇹

Fondazione G. Pascale, Naples, Italy

🇮🇹

University Federico II of Naples, Naples, Italy

and more 2 locations

Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-05-04
Last Posted Date
2022-08-22
Lead Sponsor
Mendus
Target Recruit Count
88
Registration Number
NCT02432846
Locations
🇵🇱

Military Institute of Medicine, Warsaw, Poland

🇺🇸

Rush University, Chicago, Illinois, United States

🇺🇸

University of Illinois, Chicago, Illinois, United States

and more 25 locations

A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)

First Posted Date
2015-04-20
Last Posted Date
2023-01-30
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
915
Registration Number
NCT02420821
Locations
🇺🇸

Lynn Cancer Institute/Boca Raton Regional Hospital, Boca Raton, Florida, United States

🇺🇸

Florida Cancer Specialists - Port Charlotte, Port Charlotte, Florida, United States

🇺🇸

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

and more 151 locations

CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors

First Posted Date
2015-03-30
Last Posted Date
2021-05-04
Lead Sponsor
Cogent Biosciences, Inc.
Target Recruit Count
51
Registration Number
NCT02401815
Locations
🇺🇸

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

🇺🇸

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

🇺🇸

OSU Comprehensive Cancer Center, Columbus, Ohio, United States

and more 3 locations

A Phase II Trial of Sunitinib and Nivolumab for KIT-mutated Advanced Melanoma

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2015-03-27
Last Posted Date
2017-02-01
Lead Sponsor
California Pacific Medical Center Research Institute
Registration Number
NCT02400385
Locations
🇺🇸

California Pacific Medical Center Research Institute, San Francisco, California, United States

A Phase II Trila of Sunitinib Schedule 4/2 vs. Shedule 2/1 as First Line Therapy in Metastatic Renal Cell Carcinoma.

First Posted Date
2015-03-25
Last Posted Date
2016-03-01
Lead Sponsor
Peking University Cancer Hospital & Institute
Target Recruit Count
80
Registration Number
NCT02398552
Locations
🇨🇳

Tianjin medical university cancer institute & hospital, Tianjin, Tianjin, China

🇨🇳

Chinese acadamy of medical science cancer institute & hospital, Beijing, Beijing, China

🇨🇳

Sun Yat-sen university cancer center, Guangzhou, Guangdong, China

and more 3 locations

The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors

Completed
Conditions
Interventions
First Posted Date
2014-11-04
Last Posted Date
2024-06-20
Lead Sponsor
Pfizer
Target Recruit Count
100
Registration Number
NCT02282059
Locations
🇨🇳

The Affiliated Tumour Hospital of Harbin Medical University, Haerbin, Heilongjiang, China

🇨🇳

Eastern Theater General Hospital,QinHuai District Medical Area, Nanjing, Jiangsu, China

🇨🇳

Air Force Medical University, Xi'an, Shanxi, China

and more 21 locations
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