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
-

Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-05-12
Last Posted Date
2014-06-30
Lead Sponsor
Pfizer
Target Recruit Count
12
Registration Number
NCT01121562
Locations
🇯🇵

National Cancer Center Hospital, Chuo-ku, Tokyo, Japan

🇯🇵

Kyushu University Hospital, Fukuoka, Japan

🇯🇵

Aichi Cancer Center Central Hospital, Nagoya, Aichi, Japan

and more 1 locations

Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer

First Posted Date
2010-05-06
Last Posted Date
2019-05-01
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
19
Registration Number
NCT01118351
Locations
🇺🇸

CCF-Fairview Hospital, Cleveland, Ohio, United States

🇺🇸

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Sunitinib Malate in Treating Patients With Locally Recurrent, Locally Advanced, Unresectable, or Metastatic Urinary Tract Cancer

First Posted Date
2010-05-06
Last Posted Date
2013-08-07
Lead Sponsor
Hospital del Mar
Target Recruit Count
41
Registration Number
NCT01118039
Locations
🇪🇸

Hospital Universitario San Carlos, Madrid, Spain

🇪🇸

Hospital Del Mar, Barcelona, Spain

🇪🇸

Hospital de la Santa Cruz i Sant Pau, Barcelona, Spain

and more 1 locations

Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma

First Posted Date
2010-04-22
Last Posted Date
2018-01-16
Lead Sponsor
Duke University
Target Recruit Count
131
Registration Number
NCT01108445
Locations
🇬🇧

The Royal Marsden NHS, London, England, United Kingdom

🇬🇧

Weston Park Hospital, Sheffield, England, United Kingdom

🇺🇸

Duke Univeristy Medical Center, Durham, North Carolina, United States

and more 15 locations

Study of Sunitinib Before and During Radiotherapy in Newly Diagnosed Biopsy-only Glioblastoma Patients

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-04-08
Last Posted Date
2013-03-11
Lead Sponsor
Grupo Español de Investigación en Neurooncología
Target Recruit Count
12
Registration Number
NCT01100177
Locations
🇪🇸

Grupo Español de Investigacion en Neurooncologia, Madrid, Spain

Gemcitabine Hydrochloride, Cisplatin, and Sunitinib Malate as First-Line Therapy in Treating Patients With Locally Advanced And/or Metastatic Transitional Cell Carcinoma of the Urothelium (SUCCINCT)

First Posted Date
2010-03-18
Last Posted Date
2018-10-26
Lead Sponsor
Cardiff University
Target Recruit Count
63
Registration Number
NCT01089088
Locations
🇬🇧

Royal Shrewsbury Hospital, Shrewsbury, Shropshire, United Kingdom

🇬🇧

Royal Bournemouth Hospital, Bournemouth, England, United Kingdom

🇬🇧

The Royal Marsden Hospitals (Surrey), Sutton, Surrey, United Kingdom

and more 13 locations

Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-03-09
Last Posted Date
2014-05-14
Lead Sponsor
Samsung Medical Center
Target Recruit Count
59
Registration Number
NCT01082809
Locations
🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients

First Posted Date
2010-02-23
Last Posted Date
2013-07-04
Lead Sponsor
Pfizer
Target Recruit Count
3
Registration Number
NCT01073644
Locations
🇵🇭

Chong Hua Hospital, Cebu City, Philippines

🇵🇭

Private Clinic, Manila, Philippines

Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma

First Posted Date
2010-02-17
Last Posted Date
2012-07-31
Lead Sponsor
Jonsson Comprehensive Cancer Center
Registration Number
NCT01070186

Neoadjuvant Sunitinib Treatment for Metastatic Clear Cell Renal Cell Carcinoma (RCC)

First Posted Date
2010-02-17
Last Posted Date
2011-06-23
Lead Sponsor
Korean Urological Oncology Society
Target Recruit Count
32
Registration Number
NCT01069770
Locations
🇰🇷

Chungbuk University Hospital, Cheonju, Korea, Republic of

🇰🇷

National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of

🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

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