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 Treating Patients With Relapsed or Refractory Esophageal or Gastroesophageal Junction Cancer

Phase 2

Completed

Conditions: Esophageal Cancer

Interventions: Drug: sunitinib malate

First Posted Date: 2008-06-20

Last Posted Date: 2017-03-21

Lead Sponsor: Tony Bekaii-Saab

Target Recruit Count: 25

Registration Number: NCT00702884

Locations: 🇺🇸
Ohio State University Medical Center, Columbus, Ohio, United States

Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer

Phase 3

Terminated

Conditions: Carcinoma, Hepatocellular

Interventions: Drug: sorafenib
Drug: sunitinib malate

First Posted Date: 2008-06-18

Last Posted Date: 2013-01-14

Lead Sponsor: Pfizer

Target Recruit Count: 1075

Registration Number: NCT00699374

Locations: 🇬🇧
Pfizer Investigational Site, London, United Kingdom

Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]

Completed

Conditions: Lymphoma, Mantle-Cell
Carcinoma, Renal Cell, Advanced
Gastrointestinal Stroma Tumors

Interventions: Drug: Sunitinib
Drug: Temsirolimus
Drug: Axitinib

First Posted Date: 2008-06-18

Last Posted Date: 2022-12-05

Lead Sponsor: Pfizer

Target Recruit Count: 1520

Registration Number: NCT00700258

Locations: 🇩🇪
Office of Detlef Muller, Bautzen, Germany
🇩🇪
Klotz, Weiden, Germany
🇩🇪
Carsten Lange, Bernburg, Germany

and more 74 locations

Pemetrexed and/or Sunitinib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Phase 2

Completed

Conditions: Recurrent Non-Small Cell Lung Carcinoma
Stage IIIB Non-Small Cell Lung Cancer AJCC v7
Stage IV Non-Small Cell Lung Cancer AJCC v7

Interventions: Other: Laboratory Biomarker Analysis
Drug: Pemetrexed Disodium
Drug: Sunitinib Malate

First Posted Date: 2008-06-17

Last Posted Date: 2022-02-08

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 130

Registration Number: NCT00698815

Locations: 🇺🇸
University of Vermont College of Medicine, Burlington, Vermont, United States
🇺🇸
Iredell Memorial Hospital, Statesville, North Carolina, United States
🇺🇸
Greenville Health System Cancer Institute-Spartanburg, Spartanburg, South Carolina, United States

and more 126 locations

Irinotecan, Carboplatin, and Sunitinib in First Line Extensive-Stage Small Cell Lung Cancer

Phase 2

Completed

Conditions: Small Cell Lung Cancer

Interventions: Drug: irinotecan
Drug: Carboplatin
Drug: sunitinib

First Posted Date: 2008-06-11

Last Posted Date: 2021-11-22

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 37

Registration Number: NCT00695292

Locations: 🇺🇸
Oncology Hematology Care, Cincinnati, Ohio, United States
🇺🇸
Florida Hospital Cancer Insitute, Orlando, Florida, United States
🇺🇸
Northeast Georgia Medical Center, Gainesville, Georgia, United States

and more 7 locations

Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response

Phase 1

Completed

Conditions: Renal Cell Cancer

Interventions: Drug: Sunitinib

First Posted Date: 2008-06-10

Last Posted Date: 2015-12-01

Lead Sponsor: University of Utah

Target Recruit Count: 25

Registration Number: NCT00694096

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States

Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy

Phase 3

Completed

Conditions: Stage IIIB Lung Non-Small Cell Cancer AJCC v7
Stage IV Non-Small Cell Lung Cancer AJCC v7

Interventions: Other: Laboratory Biomarker Analysis
Other: Placebo
Other: Quality-of-Life Assessment
Drug: Sunitinib Malate

First Posted Date: 2008-06-09

Last Posted Date: 2019-06-11

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 210

Registration Number: NCT00693992

Locations: 🇺🇸
Grant Medical Center, Columbus, Ohio, United States
🇺🇸
The Mark H Zangmeister Center, Columbus, Ohio, United States
🇺🇸
Hematology Oncology Associates of Illinois - Skokie, Skokie, Illinois, United States

and more 477 locations

Study Testing the Biologic Activity and Safety of a Immunotherapeutic in Patients With Newly Diagnosed Advanced Stage Kidney Cancer in Combination With a Marketed Renal Cell Carcinoma Treatment

Phase 2

Completed

Conditions: Renal Cell Carcinoma

Interventions: Biological: AGS-003
Drug: Sunitinib

First Posted Date: 2008-05-15

Last Posted Date: 2013-07-15

Lead Sponsor: Argos Therapeutics

Target Recruit Count: 25

Registration Number: NCT00678119

Locations: 🇺🇸
University of Kansas Hospital, Kansas City, Kansas, United States
🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
Emory University, Atlanta, Georgia, United States

and more 11 locations