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 for Refractory Malignant Ascites

Phase 2

Terminated

Conditions: Ascites

Interventions: Drug: Sunitinib

First Posted Date: 2008-11-24

Last Posted Date: 2017-12-20

Lead Sponsor: Milton S. Hershey Medical Center

Target Recruit Count: 4

Registration Number: NCT00796861

Locations: 🇺🇸
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

Bacillus Calmette-Guerin Followed by Sunitinib for the Treatment of High Risk Non-muscle Invasive Lower Urinary Tract Urothelial Carcinoma

Phase 2

Completed

Conditions: Urinary Tract Urothelial Carcinoma

Interventions: Drug: Sunitinib

First Posted Date: 2008-11-21

Last Posted Date: 2019-09-23

Lead Sponsor: University of Michigan

Target Recruit Count: 43

Registration Number: NCT00794950

Locations: 🇺🇸
Alon Weizer, MD, Ann Arbor, Michigan, United States
🇺🇸
Mark P. Schoenberg, MD, Baltimore, Maryland, United States

Sunitinib as Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Transitional Cell Cancer

Phase 2

Completed

Conditions: Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter

First Posted Date: 2008-11-17

Last Posted Date: 2011-05-17

Lead Sponsor: Institut Curie

Target Recruit Count: 80

Registration Number: NCT00792025

Locations: 🇫🇷
Centre Rene Huguenin, Saint Cloud, France
🇫🇷
Hopital Foch, Suresnes, France

Sunitinib Malate and Capecitabine in Treating Patients With Unresectable or Metastatic Liver Cancer

Phase 2

Terminated

Conditions: Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer

Interventions: Drug: sunitinib malate
Drug: capecitabine

First Posted Date: 2008-11-10

Last Posted Date: 2017-06-01

Lead Sponsor: University of Washington

Target Recruit Count: 41

Registration Number: NCT00787787

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Clinical Study of SU 11248 (Sutent) Combined With Standard Chemotherapy in Patients With FLT3 Mutated AML Over 60 Years

Phase 1

Completed

Conditions: Acute Myeloid Leukemia

First Posted Date: 2008-11-02

Last Posted Date: 2020-02-25

Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Target Recruit Count: 22

Registration Number: NCT00783653

Locations: 🇩🇪
PD Dr. med. Jürgen Krauter, Hannover, Germany
🇩🇪
Prof. Dr. med. Walter Fiedler, Hamburg, Germany
🇩🇪
Dr. Richard Schlenk, Ulm, Germany

and more 2 locations

Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma

Phase 2

Completed

Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer

Interventions: Drug: Sunitinib

First Posted Date: 2008-10-07

Last Posted Date: 2018-08-24

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 36

Registration Number: NCT00768144

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth-Israel Deaconess Medical Center, Boston, Massachusetts, United States

Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma

Phase 1

Conditions: Soft Tissue Sarcoma

First Posted Date: 2008-09-16

Last Posted Date: 2011-06-23

Lead Sponsor: Australasian Sarcoma Study Group

Target Recruit Count: 26

Registration Number: NCT00753727

Locations: 🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Sunitinib as First-Line Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

Phase 2

Withdrawn

Conditions: Lung Cancer

Interventions: Drug: paclitaxel albumin-stabilized nanoparticle formulation
Drug: sunitinib malate

First Posted Date: 2008-09-08

Last Posted Date: 2018-08-08

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Registration Number: NCT00748163

An Open-label Phase II Study With SUTENT in Patients Suffering From Hormone Refractory Prostate Cancer

Phase 2

Completed

Conditions: Prostatic Neoplasms
Neoplasms, Hormone-Dependent
Tumor Markers, Biological
Survival Rate
Disease-Free Survival

Interventions: Drug: sunitinib

First Posted Date: 2008-09-08

Last Posted Date: 2013-09-18

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 50

Registration Number: NCT00748358

Locations: 🇫🇷
Service Oncologie Médicale, Hopital Europeen Georges Pompidou, Paris, France

Sunitinib Before and After Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed By Surgery

Phase 1

Terminated

Conditions: Kidney Cancer

Interventions: Drug: sunitinib malate
Genetic: gene expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Genetic: western blotting
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery

First Posted Date: 2008-09-05

Last Posted Date: 2015-10-22

Lead Sponsor: Harry Drabkin

Target Recruit Count: 17

Registration Number: NCT00747305

Locations: 🇺🇸
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States

Drug Development Updates

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