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 Maintenance Therapy After Induction Platinum-Based Chemotherapy in Patients With ES-SCLC

Phase 2

Completed

Conditions: Extensive-Stage Small Cell Lung Cancer

Interventions: Drug: sunitinib

First Posted Date: 2008-02-15

Last Posted Date: 2014-04-21

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 16

Registration Number: NCT00616109

Locations: 🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer

Phase 2

Terminated

Conditions: Colorectal Neoplasms

Interventions: Drug: sunitinib
Drug: bevacizumab
Drug: mFOLFOX6

First Posted Date: 2008-02-07

Last Posted Date: 2012-10-11

Lead Sponsor: Pfizer

Target Recruit Count: 191

Registration Number: NCT00609622

Locations: 🇯🇵
Pfizer Investigational Site, Chuo-ku, Tokyo, Japan

A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma

Phase 2

Completed

Conditions: Anaplastic Astrocytoma
Glioblastoma

Interventions: Drug: Sunitinib Malate

First Posted Date: 2008-02-01

Last Posted Date: 2012-11-19

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 30

Registration Number: NCT00606008

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Phase II Sunitinib Prog Met AIPC

Phase 2

Completed

Conditions: Metastatic Prostate Cancer

Interventions: Drug: Sunitinib

First Posted Date: 2008-01-23

Last Posted Date: 2018-10-25

Lead Sponsor: US Oncology Research

Target Recruit Count: 36

Registration Number: NCT00599313

Locations: 🇺🇸
Maryland Oncology Hematology, P.A., Columbia, Maryland, United States
🇺🇸
Puget Sound Cancer Center-Seattle, Seattle, Washington, United States
🇺🇸
Cancer Care & Hematology Specialista of Chicagoland, Niles, Illinois, United States

and more 39 locations

Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma

Phase 2

Completed

Conditions: CNS Cancer
Intracranial Hemangiopericytoma
Meningioma
Hemangioblastoma
Neurofibromatosis

Interventions: Drug: Sunitinib

First Posted Date: 2008-01-10

Last Posted Date: 2016-01-25

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 50

Registration Number: NCT00589784

Locations: 🇺🇸
University of Virginia Health Science Center, Charlottesville, Virginia, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center at Commack, Commack, New York, United States

and more 3 locations

Interaction Study of Rapamycin and Sunitinib in Patients With Advanced Cancers

Early Phase 1

Completed

Conditions: Solid Tumors

Interventions: Drug: sunitinib
Drug: rapamycin

First Posted Date: 2007-12-31

Last Posted Date: 2013-06-12

Lead Sponsor: University of Chicago

Target Recruit Count: 23

Registration Number: NCT00583063

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States

SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

Phase 2

Completed

Conditions: Mucosal Lentiginous Melanoma
Acral Lentiginous Malignant Melanoma

Interventions: Drug: Sunitinib

First Posted Date: 2007-12-20

Last Posted Date: 2016-12-08

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 52

Registration Number: NCT00577382

Locations: 🇺🇸
Washington University in St. Louis, St. Louis, Missouri, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 2 locations

Imatinib Mesylate and Sunitinib in Treating Patients With Gastrointestinal Stromal Tumors

Phase 1

Terminated

Conditions: Gastrointestinal Stromal Tumor

Interventions: Drug: imatinib mesylate
Drug: sunitinib malate
Other: pharmacological study

First Posted Date: 2007-12-14

Last Posted Date: 2011-11-16

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 6

Registration Number: NCT00573404

Locations: 🇺🇸
Vanderbilt-Ingram Cancer Center - Cool Springs, Nashville, Tennessee, United States
🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
🇺🇸
Vanderbilt-Ingram Cancer Center at Franklin, Nashville, Tennessee, United States