Sunitinib

Generic Name: Sunitinib

Brand Names: Sutent, Sunitinib Accord

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₇FN_₄O_₂

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: -

Clinical Trials

Sunitinib in Refractory Adrenocortical Carcinoma

Phase 2

Completed

Conditions: Adrenocortical Carcinoma

Interventions: Drug: Sunitinib

First Posted Date: 2007-03-29

Last Posted Date: 2019-01-31

Lead Sponsor: University of Wuerzburg

Target Recruit Count: 39

Registration Number: NCT00453895

Locations: 🇩🇪
Charite Berlin, Berlin, Germany
🇩🇪
Dept. of Medicine I, University of Wuerzburg, Wuerzburg, Germany

Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment

Phase 2

Completed

Conditions: Ovarian Cancer
Teratoma
Extragonadal Germ Cell Tumor
Testicular Germ Cell Tumor

Interventions: Drug: sunitinib malate

First Posted Date: 2007-03-28

Last Posted Date: 2015-10-27

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 10

Registration Number: NCT00453310

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Cisplatin or Carboplatin, and Etoposide With or Without Sunitinib Malate in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Phase 1

Completed

Conditions: Extensive Stage Lung Small Cell Carcinoma
Recurrent Lung Small Cell Carcinoma

Interventions: Drug: Carboplatin
Drug: Cisplatin
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Other: Placebo Administration
Drug: Sunitinib Malate

First Posted Date: 2007-03-28

Last Posted Date: 2023-04-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 156

Registration Number: NCT00453154

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
Heartland Cancer Research NCORP, Decatur, Illinois, United States
🇺🇸
Illinois CancerCare-Princeton, Princeton, Illinois, United States

and more 122 locations

Sunitinib in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

Phase 2

Completed

Conditions: Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndromes
Myelodysplastic Syndromes
Secondary Myelodysplastic Syndromes

Interventions: Drug: sunitinib malate

First Posted Date: 2007-03-22

Last Posted Date: 2018-09-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 10

Registration Number: NCT00451048

Locations: 🇨🇦
Odette Cancer Centre- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States
🇨🇦
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada

and more 1 locations

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

Completed

Conditions: Gastrointestinal Stromal Tumors

Interventions: Drug: sunitinib malate

First Posted Date: 2007-03-08

Last Posted Date: 2017-02-01

Lead Sponsor: Pfizer

Target Recruit Count: 520

Registration Number: NCT00444795

Locations: 🇰🇷
Hwasun Hospital, Chonnam National University, Cheonnam, Korea, Republic of
🇰🇷
Soonchunhyang University Bucheon Hospital, Bucheon, Gyeonggi-do, Korea, Republic of
🇰🇷
Chosun University Hospital, Gwang Joo, Korea, Republic of

and more 41 locations

Phase 2 Study of Panzem® NCD Alone and Combined With Sunitinib Malate in Patients With Metastatic Renal Cell Carcinoma

Phase 2

Completed

Conditions: Metastatic Renal Cell Carcinoma

Interventions: Drug: Panzem® NCD
Drug: Sunitinib Malate

First Posted Date: 2007-03-07

Last Posted Date: 2011-08-04

Lead Sponsor: CASI Pharmaceuticals, Inc.

Target Recruit Count: 82

Registration Number: NCT00444314

Locations: 🇺🇸
Indiana University Cancer Center, Indianapolis, Indiana, United States
🇺🇸
Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
🇺🇸
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States