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 Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer

Phase 2

Completed

Conditions: Endometrial Adenocarcinoma
Endometrial Serous Adenocarcinoma
Uterine Carcinosarcoma
Endometrial Endometrioid Adenocarcinoma
Stage IVB Uterine Corpus Cancer AJCC v7
Uterine Corpus Carcinosarcoma
Recurrent Uterine Corpus Carcinoma
Stage IVA Uterine Corpus Cancer AJCC v7

Interventions: Drug: Sunitinib Malate

First Posted Date: 2007-05-24

Last Posted Date: 2020-02-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 34

Registration Number: NCT00478426

Locations: 🇨🇦
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
🇺🇸
Loyola University Medical Center, Maywood, Illinois, United States
🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

and more 26 locations

Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas

Phase 2

Completed

Conditions: Desmoid Tumor
Endometrial Cancer
Adult Malignant Fibrous Histiocytoma of Bone
Ovarian Cancer
Sarcoma
Small Intestine Cancer

Interventions: Drug: sunitinib malate

First Posted Date: 2007-05-17

Last Posted Date: 2016-01-20

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 53

Registration Number: NCT00474994

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States

Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer

Phase 2

Completed

Conditions: Breast Neoplasms

Interventions: Drug: sunitinib

First Posted Date: 2007-05-09

Last Posted Date: 2011-07-25

Lead Sponsor: Pfizer

Target Recruit Count: 83

Registration Number: NCT00471276

Locations: 🇺🇸
Pfizer Investigational Site, Everett, Washington, United States

Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer

Phase 2

Completed

Conditions: Renal Cell Cancer
Kidney Cancer

Interventions: Drug: Sunitinib Malate

First Posted Date: 2007-04-24

Last Posted Date: 2016-06-07

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 61

Registration Number: NCT00465179

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma

Phase 2

Completed

Conditions: Kidney Cancer
Melanoma (Skin)
Metastatic Cancer

Interventions: Drug: sunitinib malate

First Posted Date: 2007-04-19

Last Posted Date: 2015-12-30

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 8

Registration Number: NCT00462982

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

Sunitinib and Gemcitabine in Treating Patients With Pancreatic Cancer or Other Solid Tumors

Phase 1

Completed

Conditions: Adenocarcinoma of the Pancreas
Stage IV Pancreatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Recurrent Pancreatic Cancer
Stage III Pancreatic Cancer

Interventions: Drug: sunitinib malate
Drug: gemcitabine hydrochloride

First Posted Date: 2007-04-19

Last Posted Date: 2014-02-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 37

Registration Number: NCT00462553

Locations: 🇺🇸
Case Western Reserve University, Cleveland, Ohio, United States

Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery

Phase 2

Completed

Conditions: Kidney Cancer

Interventions: Drug: sunitinib malate
Procedure: conventional surgery

First Posted Date: 2007-04-13

Last Posted Date: 2014-03-07

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 30

Registration Number: NCT00459979

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

Phase 2

Completed

Conditions: Kidney Cancer

Interventions: Drug: sunitinib malate

First Posted Date: 2007-04-13

Last Posted Date: 2015-11-26

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 24

Registration Number: NCT00459875

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

A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone

Phase 3

Completed

Conditions: Carcinoma, Non-Small Cell Lung

Interventions: Drug: erlotinib
Drug: placebo
Drug: sunitinib

First Posted Date: 2007-04-06

Last Posted Date: 2013-10-29

Lead Sponsor: Pfizer

Target Recruit Count: 960

Registration Number: NCT00457392

Locations: 🇬🇧
Pfizer Investigational Site, Yeovil, Somerset, United Kingdom

Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer

Phase 3

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: 5 fluorouracil
Drug: irinotecan
Drug: levo- leucovorin
Drug: placebo
Drug: sunitinib

First Posted Date: 2007-04-06

Last Posted Date: 2015-03-30

Lead Sponsor: Pfizer

Target Recruit Count: 768

Registration Number: NCT00457691

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

Drug Development Updates

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