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 Study of Alternating Sunitinib and Temsirolimus

Phase 2

Completed

Conditions: Metastatic Renal Cell Carcinoma

Interventions: Drug: Sunitinib
Drug: Temsirolimus

First Posted Date: 2012-01-25

Last Posted Date: 2023-09-21

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Target Recruit Count: 37

Registration Number: NCT01517243

Locations: 🇺🇸
University of Vermont, Vermont Cancer Center, Burlington, Vermont, United States
🇺🇸
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib

Phase 2

Completed

Conditions: Gastro Intestinal Stromal Tumor

Interventions: Drug: masitinib
Drug: sunitinib

First Posted Date: 2012-01-10

Last Posted Date: 2018-12-11

Lead Sponsor: AB Science

Target Recruit Count: 44

Registration Number: NCT01506336

Locations: 🇫🇷
Institute Gustave Roussy (IGR), Villejuif, France

PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma

Not Applicable

Terminated

Conditions: Renal Cell Carcinoma

Interventions: Drug: 150-Water
Drug: 62Cu-ethylglyoxal bis
Procedure: Positron Emission Tomography
Drug: Sunitinib

First Posted Date: 2011-12-30

Last Posted Date: 2019-03-05

Lead Sponsor: Indiana University

Target Recruit Count: 14

Registration Number: NCT01502228

Locations: 🇺🇸
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States

Study of Efficacy and Safety of Sunitinib Given on an Individualized Schedule

Phase 2

Completed

Conditions: Clear Cell, Metastatic Renal Cell Carcinoma

Interventions: Drug: Sunitinib

First Posted Date: 2011-12-26

Last Posted Date: 2018-03-06

Lead Sponsor: Sunnybrook Health Sciences Centre

Target Recruit Count: 117

Registration Number: NCT01499121

Locations: 🇨🇦
Cross Cancer Institute, Edmonton, Alberta, Canada
🇨🇦
Juravinski Cancer Centre, Hamilton, Ontario, Canada
🇨🇦
Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada

and more 10 locations

Safety Study of Preoperative Sunitinib and Radiation in Soft Tissue Sarcoma

Phase 1

Completed

Conditions: Soft Tissue Sarcoma

Interventions: Drug: Sunitinib

First Posted Date: 2011-12-23

Last Posted Date: 2017-08-28

Lead Sponsor: Heidelberg University

Target Recruit Count: 9

Registration Number: NCT01498835

Locations: 🇩🇪
Helios Klinikum Bad Saarow, Bad Saarow, Germany
🇩🇪
University Medical Center Mannheim, Mannheim, Germany

Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016)

Phase 1

Completed

Conditions: Renal Cell Carcinoma
Clear-cell Metastatic Renal Cell Carcinoma

Interventions: Biological: Nivolumab
Biological: Pazopanib
Biological: Ipilimumab
Drug: Sunitinib

First Posted Date: 2011-11-16

Last Posted Date: 2021-12-02

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 194

Registration Number: NCT01472081

Locations: 🇺🇸
City Of Hope, Duarte, California, United States
🇺🇸
Memorial Sloan Kettering Nassau, New York, New York, United States
🇺🇸
Blumenthal Cancer Center, Charlotte, North Carolina, United States

and more 11 locations

Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma

Phase 2

Completed

Conditions: Childhood Cerebral Anaplastic Astrocytoma
Childhood Infratentorial Ependymoma
Childhood Oligodendroglioma
Recurrent Childhood Cerebellar Astrocytoma
Recurrent Childhood Ependymoma
Recurrent Childhood Subependymal Giant Cell Astrocytoma
Childhood Cerebral Astrocytoma
Childhood Cerebellar Anaplastic Astrocytoma
Recurrent Childhood Cerebral Astrocytoma
Childhood Mixed Glioma

Interventions: Other: Diagnostic Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Sunitinib Malate

First Posted Date: 2011-10-31

Last Posted Date: 2015-08-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 30

Registration Number: NCT01462695

Locations: 🇺🇸
Nationwide Children's Hospital, Columbus, Ohio, United States
🇺🇸
Children's Hospital Central California, Madera, California, United States
🇺🇸
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

and more 93 locations

Cytochrom p450 3A4 and 1A2 Phenotyping for the Individualization of Treatment With Sunitinib or Erlotinib in Cancer Patients

Phase 4

Completed

Conditions: Gastrointestinal Stroma Tumor
Non Small-cell Lung Cancer
Renal-cell Cancer

First Posted Date: 2011-07-26

Last Posted Date: 2016-02-02

Lead Sponsor: Markus Joerger

Target Recruit Count: 54

Registration Number: NCT01402089

Locations: 🇨🇭
Cantonal Hospital St.Gallen, St.Gallen, Switzerland

A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor

Phase 2

Completed

Conditions: Gastrointestinal Stromal Tumors

Interventions: Drug: sunitinib malate dose escalation
Drug: sunitinib malate

First Posted Date: 2011-07-18

Last Posted Date: 2019-03-27

Lead Sponsor: Pfizer

Target Recruit Count: 6

Registration Number: NCT01396148

Locations: 🇺🇸
Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Los Angeles, California, United States
🇨🇿
Fakultni nemocnice Brno, Brno, Czechia
🇨🇿
FN Brno, Brno, Czechia

and more 6 locations

A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours

Phase 2

Active, not recruiting

Conditions: Advanced Rare Tumours

Interventions: Drug: Sunitinib
Drug: Temsirolimus

First Posted Date: 2011-07-18

Last Posted Date: 2024-02-26

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 137

Registration Number: NCT01396408

Locations: 🇨🇦
Hospital for Sick Children, Toronto, Ontario, Canada
🇨🇦
Tom Baker Cancer Centre, Calgary, Alberta, Canada
🇨🇦
Cross Cancer Institute, Edmonton, Alberta, Canada

and more 14 locations

Drug Development Updates

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