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

Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy

Phase 2

Completed

Conditions: Prostate Cancer
Prostatectomy

Interventions: Drug: Sunitinib Malate

First Posted Date: 2008-05-06

Last Posted Date: 2014-08-04

Lead Sponsor: Duke University

Target Recruit Count: 30

Registration Number: NCT00672594

Locations: 🇺🇸
MD Anderson, University of Texas, Houston, Texas, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

Study Of Sunitinib With FOLFIRI In Colorectal Cancer

Phase 2

Completed

Conditions: Unresectable or Metastatic Colorectal Cancer

Interventions: Drug: FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil)
Drug: Sunitinib

First Posted Date: 2008-04-29

Last Posted Date: 2011-10-17

Lead Sponsor: Pfizer

Target Recruit Count: 71

Registration Number: NCT00668863

Locations: 🇯🇵
Pfizer Investigational Site, Minoh/Osaka, Japan

Sunitinib in Patients With Renal Cells Carcinoma Metastasic or Locally Avanced in Patients Not Candidates to Curative Previous Nefrectomy

Phase 2

Completed

Conditions: Carcinoma Renal Cells

Interventions: Drug: Sunitinib

First Posted Date: 2008-04-22

Last Posted Date: 2014-12-18

Lead Sponsor: Spanish Oncology Genito-Urinary Group

Target Recruit Count: 59

Registration Number: NCT00663559

Locations: 🇪🇸
Hospital Parc Taulí, Sabadell, Barcelona, Spain
🇪🇸
Hospital lozano Blesa, Zaragoza, Spain
🇪🇸
Hospital CLINIC, Barcelona, Spain

and more 4 locations

Study Of Sunitinib With Capecitabine In Breast Cancer

Phase 2

Completed

Conditions: Advanced/Metastatic Breast Cancer

Interventions: Drug: Capecitabine
Drug: Sunitinib

First Posted Date: 2008-04-21

Last Posted Date: 2013-05-27

Lead Sponsor: Pfizer

Target Recruit Count: 63

Registration Number: NCT00662025

Locations: 🇯🇵
Pfizer Investigational Site, Osaka, Japan

Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer

Phase 1

Completed

Conditions: Prostate Cancer

Interventions: Drug: Leuprolide
Drug: Goserelin
Drug: Sunitinib Malate
Drug: Casodex
Radiation: Radiation Therapy (RT)

First Posted Date: 2008-03-07

Last Posted Date: 2015-01-29

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 19

Registration Number: NCT00631527

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Sunitinib Before or After Surgery in Treating Patients With Metastatic Kidney Cancer

Phase 2

Conditions: Kidney Cancer

First Posted Date: 2008-02-29

Last Posted Date: 2013-08-12

Lead Sponsor: Gruppo Italiano Carcinoma Renale

Target Recruit Count: 110

Registration Number: NCT00626509

Locations: 🇮🇹
Ospedale Sacro Cuore, Negrar, Italy

Sunitinib as a Second-line Treatment for Patients With Recurrent Small Cell Lung Cancer

Phase 2

Completed

Conditions: Lung Cancer

Interventions: Drug: sunitinib

First Posted Date: 2008-02-21

Last Posted Date: 2013-06-19

Lead Sponsor: National Cancer Center, Korea

Target Recruit Count: 25

Registration Number: NCT00620347

Locations: 🇰🇷
National Cancer Center, Korea, Goyang-si, Gyeonggi-do, Korea, Republic of

Combination of Temsirolimus and Bevacizumab in Patient With Metastatic Renal Cell Carcinoma

Phase 2

Completed

Conditions: Metastatic Renal Cell Carcinoma

Interventions: Drug: Sunitinib
Drug: Temsirolimus
Drug: Bevacizumab
Drug: Interferon alpha-2a

First Posted Date: 2008-02-20

Last Posted Date: 2013-02-15

Lead Sponsor: Centre Leon Berard

Target Recruit Count: 160

Registration Number: NCT00619268

Locations: 🇫🇷
Centre Jean Perrin, Clermont Ferrand, France
🇫🇷
Centre Hospitalier Universitaire de Bordeaux - Hôpital St André, Bordeaux, France
🇫🇷
Centre Hospitalier Universiariare Lyon, Hôpital Lyon Sud, Lyon, France

and more 26 locations