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

AMG 386 Phase 2 Open-Label Renal Cell Carcinoma (RCC) Study 1st Line or After Cytokine Failure in Combination With Sunitinib

Phase 2

Completed

Conditions: Advanced Renal Cell Carcinoma

Interventions: Drug: Sunitinib
Drug: Trebananib

First Posted Date: 2009-03-02

Last Posted Date: 2020-07-01

Lead Sponsor: Amgen

Target Recruit Count: 85

Registration Number: NCT00853372

Sunitinib and Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

Phase 2

Terminated

Conditions: Kidney Cancer

Interventions: Biological: therapeutic allogeneic lymphocytes
Drug: sunitinib malate

First Posted Date: 2009-03-02

Last Posted Date: 2021-04-27

Lead Sponsor: Rutgers, The State University of New Jersey

Target Recruit Count: 10

Registration Number: NCT00853125

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer

Not Applicable

Completed

Conditions: Kidney Cancer

Interventions: Drug: sunitinib malate
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery

First Posted Date: 2009-02-23

Last Posted Date: 2015-02-06

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 20

Registration Number: NCT00849186

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

Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer

Phase 2

Completed

Conditions: Bladder Cancer
Urinary Bladder

Interventions: Drug: Sunitinib
Drug: Gemcitabine
Drug: cisplatin

First Posted Date: 2009-02-19

Last Posted Date: 2016-02-29

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 18

Registration Number: NCT00847015

Locations: 🇺🇸
Memorial Sloan-Kettering at Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center @ Suffolk, Commack, New York, United States
🇺🇸
Memoral Sloan Kettering Cancer Center@Phelps, Sleepy Hollow, New York, United States

and more 2 locations

Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma

Phase 2

Completed

Conditions: Pheochromocytoma
Paraganglioma

Interventions: Drug: Sunitinib

First Posted Date: 2009-02-13

Last Posted Date: 2024-10-17

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 25

Registration Number: NCT00843037

Locations: 🇳🇱
University Medical Centre Groningen, Groningen, Netherlands
🇨🇦
University Health Network, Princess Margaret Cancer Centre, Toronto, Ontario, Canada
🇨🇦
Tom Baker Cancer Centre, Calgary, Alberta, Canada

and more 1 locations

Sunitinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Who Have Tumor Cells in the Bone Marrow

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Drug: sunitinib malate
Other: flow cytometry
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

First Posted Date: 2009-01-16

Last Posted Date: 2018-04-05

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 13

Registration Number: NCT00824538

Activity Study of Sunitinib In Metastatic Pretreated Urothelial Cancer

Phase 1

Conditions: Urinary Bladder Neoplasms

Interventions: Drug: SUNITINIB

First Posted Date: 2009-01-07

Last Posted Date: 2009-01-07

Lead Sponsor: Campania Younger Oncologists Association

Target Recruit Count: 25

Registration Number: NCT00818350

Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain

Phase 2

Completed

Conditions: Kidney Cancer
Metastatic Cancer

Interventions: Drug: sunitinib malate

First Posted Date: 2008-12-23

Last Posted Date: 2014-11-05

Lead Sponsor: Institut Claudius Regaud

Target Recruit Count: 21

Registration Number: NCT00814021

Locations: 🇫🇷
Institut Claudius Regaud, Toulouse, France

Sunitinib Malate and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Chemotherapy

Phase 1

Completed

Conditions: Adult Solid Neoplasm

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

First Posted Date: 2008-12-23

Last Posted Date: 2023-08-02

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 40

Registration Number: NCT00813423

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Rollover Protocol for Prior SU011248 Protocols

Not Applicable

Completed

Conditions: Solid Tumors

Interventions: Drug: Sunitinib

First Posted Date: 2008-11-26

Last Posted Date: 2013-01-21

Lead Sponsor: Pfizer

Target Recruit Count: 314

Registration Number: NCT00798889

Locations: 🇬🇧
Pfizer Investigational Site, Newcastle-Upon-Tyne, United Kingdom

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