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, Irinotecan, Fluorouracil, and Leucovorin In Treating Patients With Advanced Stomach Cancer or Gastroesophageal Cancer

Phase 1

Terminated

Conditions: Gastric Cancer
Esophageal Cancer

Interventions: Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: sunitinib malate
Other: flow cytometry
Other: pharmacological study

First Posted Date: 2007-09-03

Last Posted Date: 2016-06-21

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 23

Registration Number: NCT00524186

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

Sunitinib and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Phase 2

Terminated

Conditions: Liver Cancer

Interventions: Drug: doxorubicin hydrochloride
Drug: sunitinib malate
Other: laboratory biomarker analysis
Procedure: hepatic artery embolization
Procedure: quality-of-life assessment

First Posted Date: 2007-09-03

Last Posted Date: 2017-05-09

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 16

Registration Number: NCT00524316

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

Study of Pegylated Alfa Interferon, Sunitinib and Tarceva in Patients With Metastatic RCC

Phase 1

Terminated

Conditions: Carcinoma, Renal Cell

Interventions: Drug: Pegylated Alfa Interferon
Drug: sunitinib
Drug: erlotinib

First Posted Date: 2007-08-29

Last Posted Date: 2016-03-17

Lead Sponsor: The Methodist Hospital Research Institute

Target Recruit Count: 10

Registration Number: NCT00522249

Locations: 🇺🇸
Baylor College of Medicine - Methodist Hospital, Houston, Texas, United States

Sunitinib Malate in Treating East African Patients With Kaposi Sarcoma

Phase 2

Withdrawn

Conditions: AIDS-related Kaposi Sarcoma
Classic Kaposi Sarcoma

Interventions: Drug: sunitinib malate
Procedure: laboratory biomarker analysis
Procedure: pharmacological study

First Posted Date: 2007-08-27

Last Posted Date: 2014-05-05

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT00521092

Study of Safety and Functional Imaging of cG250 and Sunitinib in Patients With Advanced Renal Cell Carcinoma

Phase 1

Terminated

Conditions: Renal Cell Carcinoma (RCC)

Interventions: Biological: Chimeric monoclonal antibody cG250
Drug: Sunitinib malate

First Posted Date: 2007-08-24

Last Posted Date: 2022-10-12

Lead Sponsor: Ludwig Institute for Cancer Research

Target Recruit Count: 8

Registration Number: NCT00520533

Locations: 🇦🇺
Austin Health (Ludwig Institute Oncology Unit), Heidelberg, Victoria, Australia

Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer

Phase 2

Completed

Conditions: Recurrent Thyroid Cancer
Stage IVA Follicular Thyroid Cancer
Stage IVA Papillary Thyroid Cancer
Stage IVB Follicular Thyroid Cancer
Stage IVB Papillary Thyroid Cancer
Stage IVC Follicular Thyroid Cancer
Stage IVC Papillary Thyroid Cancer
Thyroid Gland Medullary Carcinoma

Interventions: Drug: sunitinib malate

First Posted Date: 2007-08-23

Last Posted Date: 2017-04-25

Lead Sponsor: University of Washington

Target Recruit Count: 35

Registration Number: NCT00519896

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

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

Phase 2

Completed

Conditions: Liver Cancer

Interventions: Drug: sunitinib malate

First Posted Date: 2007-08-09

Last Posted Date: 2012-06-26

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 45

Registration Number: NCT00514228

Locations: 🇨🇭
Kantonsspital - St. Gallen, St. Gallen, Switzerland

Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer

Phase 2

Completed

Conditions: Stage II Breast Cancer
Inflammatory Breast Cancer
Male Breast Cancer
Stage IIIC Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer

Interventions: Drug: sunitinib malate
Drug: paclitaxel
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Biological: filgrastim
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Other: flow cytometry

First Posted Date: 2007-08-09

Last Posted Date: 2019-08-07

Lead Sponsor: University of Washington

Target Recruit Count: 68

Registration Number: NCT00513695

Locations: 🇺🇸
Skagit Valley Hospital, Mount Vernon, Washington, United States
🇺🇸
Olympic Medical Center, Port Angeles, Washington, United States
🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

and more 4 locations

Sunitinib in Treating Patients With Relapsed Multiple Myeloma

Phase 2

Completed

Conditions: Refractory Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Stage I Multiple Myeloma

Interventions: Drug: sunitinib malate

First Posted Date: 2007-08-09

Last Posted Date: 2014-05-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 13

Registration Number: NCT00514137

Locations: 🇺🇸
Mayo Clinic Cancer Research Consortium, Rochester, Minnesota, United States

Thyroid Cancer and Sunitinib

Phase 2

Completed

Conditions: Cancer
Thyroid Carcinoma

Interventions: Drug: Sunitinib

First Posted Date: 2007-08-02

Last Posted Date: 2013-02-28

Lead Sponsor: University Hospital, Bordeaux

Target Recruit Count: 71

Registration Number: NCT00510640

Locations: 🇫🇷
Centre Paul Papin - 2 rue Moll, Angers, France
🇫🇷
Département Endocrinolo-Diabéto-Nutrition - CHU d'Angers - 4 rue de Larray, Angers, France
🇫🇷
Service d'Oncologie Médicale et de Radiothérapie - Hôpital Saint André - 1 rue Jean Burguet, Bordeaux, France

and more 12 locations

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