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

Trial Of Sunitinib In Advanced Non-Clear Cell Type Renal Cell Carcinoma

Phase 2

Conditions: Metastatic Renal Cell Carcinoma

Interventions: Drug: Sunitinib

First Posted Date: 2010-10-13

Last Posted Date: 2011-06-17

Lead Sponsor: Asan Medical Center

Target Recruit Count: 35

Registration Number: NCT01219751

Locations: 🇰🇷
Asan Medical Center, Seoul, Korea, Republic of

Trial of Single Agent Sunitinib for Patients With Chemo-refractory Metastatic Melanoma

Phase 2

Terminated

Conditions: Chemo-refractory Melanoma

Interventions: Drug: Sunitinib

First Posted Date: 2010-10-07

Last Posted Date: 2013-06-04

Lead Sponsor: Krankenhaus Nordwest

Target Recruit Count: 7

Registration Number: NCT01216657

Locations: 🇩🇪
Krankenhaus Nordwest, Frankfurt/Main, Germany

Resection of Pulmonary Metastasis in Clear Cell Renal Cell Carcinoma +/-Adjuvant Sunitinib Therapy (SMAT)

Phase 2

Conditions: Renal Cell Carcinoma
Pulmonary Metastases

Interventions: Drug: Placebo
Drug: Sunitinib

First Posted Date: 2010-10-07

Last Posted Date: 2012-02-13

Lead Sponsor: Association of Urologic Oncology (AUO)

Target Recruit Count: 60

Registration Number: NCT01216371

Locations: 🇩🇪
university hospital of Freiburg, Freiburg, Germany
🇩🇪
Universitätsmedizin Charité Berlin, Berlin, Germany
🇩🇪
university hospital of Essen, Essen, Germany

and more 8 locations

Everolimus Versus Sunitinib in Non-Clear Cell Renal Cell Carcinoma

Phase 2

Terminated

Conditions: Kidney Cancer

Interventions: Drug: Everolimus
Drug: Sunitinib

First Posted Date: 2010-08-19

Last Posted Date: 2021-04-28

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 73

Registration Number: NCT01185366

Locations: 🇺🇸
Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Huntsman Cancer Institute - University of Utah, Salt Lake City, Utah, United States

and more 1 locations

Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease

Phase 2

Completed

Conditions: Von Hippel-Lindau Disease

First Posted Date: 2010-07-23

Last Posted Date: 2012-09-13

Lead Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Target Recruit Count: 5

Registration Number: NCT01168440

Locations: 🇫🇷
Hôpital Européen Georges Pompidou - Service d'Oncologie Médicale, Paris, France
🇫🇷
Hospital Saint André - Service de cancérologie, Bordeaux, France
🇫🇷
Hopital Kremlin-Bicêtre, Kremlin-Bicêtre, France

Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery

Phase 2

Completed

Conditions: Kidney Cancer

Interventions: Drug: Gemcitabine
Drug: Sunitinib

First Posted Date: 2010-07-16

Last Posted Date: 2023-06-15

Lead Sponsor: ECOG-ACRIN Cancer Research Group

Target Recruit Count: 87

Registration Number: NCT01164228

Locations: 🇺🇸
CCOP - Christiana Care Health Services, Newark, Delaware, United States
🇺🇸
North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville, Illinois, United States
🇺🇸
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States

and more 96 locations