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

Phase II Trial of Sunitinib in BAC or Never-Smokers With Any Lung Adenocarcinoma

Phase 2

Completed

Conditions: Lung Cancer
Adenocarcinoma

First Posted Date: 2007-02-01

Last Posted Date: 2010-10-06

Lead Sponsor: Swedish Medical Center

Target Recruit Count: 20

Registration Number: NCT00430261

Locations: 🇺🇸
Swedish Cancer Institute, Seattle, Washington, United States

A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors

Phase 3

Terminated

Conditions: Carcinoma, Islet Cell
Carcinoma, Pancreas

Interventions: Drug: Placebo
Drug: sunitinib malate

First Posted Date: 2007-01-30

Last Posted Date: 2010-10-11

Lead Sponsor: Pfizer

Target Recruit Count: 171

Registration Number: NCT00428597

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

A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.

Not Applicable

Completed

Conditions: Pancreatic Islet Cell Carcinoma
Advanced/Metastatic Non-Small Cell Lung Cancer
Metastatic Breast Cancer
Advanced Breast Cancer
Thyroid Cancer
Hepatocellular Carcinoma
Metastatic Castration Resistant Prostate Cancer
Metastatic Renal Cell Cancer
Non-Small Cell Lung Cancer
Advanced Gastric Cancer

Interventions: Drug: sunitinib

First Posted Date: 2007-01-29

Last Posted Date: 2019-06-27

Lead Sponsor: Pfizer

Target Recruit Count: 223

Registration Number: NCT00428220

Locations: 🇨🇳
Chi-Mei Medical Center, YungKang City, Tainan, Taiwan
🇨🇴
Fundacion Centro de Investigacion Clinica CIC, Medellin, Anquioquia, Colombia
🇦🇺
Austin Health, Heidelberg, Victoria, Australia

and more 109 locations

Sunitinib and Erlotinib in Treating Patients With Unresectable or Metastatic Kidney Cancer

Phase 2

Completed

Conditions: Kidney Cancer

Interventions: Drug: erlotinib hydrochloride
Drug: sunitinib malate
Procedure: biopsy

First Posted Date: 2007-01-23

Last Posted Date: 2017-05-03

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 60

Registration Number: NCT00425386

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
🇺🇸
University of Southern California, Los Angeles, California, United States
🇺🇸
Salem Hospital, Salem, Oregon, United States

and more 1 locations

A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer

Phase 1

Terminated

Conditions: Breast Neoplasms

Interventions: Drug: exemestane
Drug: sunitinib malate

First Posted Date: 2007-01-04

Last Posted Date: 2010-09-21

Lead Sponsor: Pfizer

Target Recruit Count: 6

Registration Number: NCT00417885

Locations: 🇨🇦
Pfizer Investigational Site, Montreal, Quebec, Canada

Study of Combination of Sirolimus and Sutent in Patients With Advanced Solid Tumors Non-Curable With Standard Therapy

Phase 1

Terminated

Conditions: Tumors

Interventions: Drug: Sunitinib malate
Drug: Rapamycin

First Posted Date: 2006-11-22

Last Posted Date: 2013-12-18

Lead Sponsor: Yale University

Target Recruit Count: 18

Registration Number: NCT00402415

Locations: 🇺🇸
Yale Comprehensive Cancer Center at Yale University School of Medicine, New Haven, Connecticut, United States

Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer

Phase 2

Completed

Conditions: Esophageal Cancer

Interventions: Drug: Irinotecan
Drug: Cisplatin
Procedure: Radiation
Procedure: Surgery
Drug: sunitinib (Sutent)

First Posted Date: 2006-11-16

Last Posted Date: 2017-05-08

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 36

Registration Number: NCT00400114

Locations: 🇨🇦
University Health Network (Princess Margaret & Toronto General Hospitals), Toronto, Ontario, Canada
🇨🇦
The Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada

Perifosine + Sunitinib Malate for Patients With Advanced Cancers

Phase 1

Completed

Conditions: Renal Cancer
GIST

Interventions: Drug: Perifosine
Drug: Sunitinib Malate

First Posted Date: 2006-11-14

Last Posted Date: 2014-02-19

Lead Sponsor: AEterna Zentaris

Target Recruit Count: 15

Registration Number: NCT00399152

Sunitinib in Treating Patients With Metastatic Pancreatic Cancer That Progressed After First-Line Therapy With Gemcitabine

Phase 2

Completed

Conditions: Recurrent Pancreatic Cancer
Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Stage IV Pancreatic Cancer

Interventions: Drug: sunitinib malate

First Posted Date: 2006-11-10

Last Posted Date: 2013-06-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 64

Registration Number: NCT00397787

Locations: 🇺🇸
Cancer and Leukemia Group B, Chicago, Illinois, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

Sunitinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase 2

Completed

Conditions: B-cell Chronic Lymphocytic Leukemia
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia

Interventions: Drug: sunitinib malate
Other: pharmacological study
Other: laboratory biomarker analysis

First Posted Date: 2006-11-10

Last Posted Date: 2014-05-14

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 18

Registration Number: NCT00398112

Locations: 🇺🇸
North Central Cancer Treatment Group, Rochester, Minnesota, United States

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