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 in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium

Phase 2

Completed

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

Interventions: Drug: sunitinib malate

First Posted Date: 2006-11-09

Last Posted Date: 2016-01-25

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 78

Registration Number: NCT00397488

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer

Phase 3

Completed

Conditions: Breast Neoplasms

Interventions: Drug: Taxotere
Drug: Sunitinib malate

First Posted Date: 2006-10-31

Last Posted Date: 2012-07-19

Lead Sponsor: Pfizer

Target Recruit Count: 594

Registration Number: NCT00393939

Locations: 🇬🇧
Pfizer Investigational Site, Wolverhampton, United Kingdom

Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma

Phase 2

Completed

Conditions: Advanced Malignant Mesothelioma
Recurrent Malignant Mesothelioma

Interventions: Drug: sunitinib malate

First Posted Date: 2006-10-26

Last Posted Date: 2014-05-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 39

Registration Number: NCT00392444

Locations: 🇨🇦
National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario, Canada

Sunitinib in Treating Patients With Relapsed or Refractory Diffuse or Mediastinal Large B-Cell Lymphoma

Phase 2

Completed

Conditions: Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma

Interventions: Drug: sunitinib malate

First Posted Date: 2006-10-26

Last Posted Date: 2014-05-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 19

Registration Number: NCT00392496

Locations: 🇨🇦
National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario, Canada

Sunitinib Malate in Treating Patients With Uterine Cervical Cancer That is Stage IVB, Recurrent, or Cannot Be Removed By Surgery

Phase 2

Completed

Conditions: Cervical Adenocarcinoma
Cervical Adenosquamous Cell Carcinoma
Recurrent Cervical Cancer
Stage IVB Cervical Cancer
Cervical Squamous Cell Carcinoma

Interventions: Drug: sunitinib malate

First Posted Date: 2006-10-19

Last Posted Date: 2015-02-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 19

Registration Number: NCT00389974

Locations: 🇨🇦
National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario, Canada

Sunitinib in Treating Young Patients With Refractory Solid Tumors

Phase 1

Completed

Conditions: Childhood Central Nervous System Embryonal Tumor
Childhood Central Nervous System Germinoma
Childhood Central Nervous System Germ Cell Tumor
Childhood Central Nervous System Mixed Germ Cell Tumor
Childhood Central Nervous System Teratoma
Central Nervous System Metastases
Childhood Central Nervous System Choriocarcinoma
Childhood Central Nervous System Yolk Sac Tumor
Recurrent Childhood Central Nervous System Embryonal Tumor
Unspecified Childhood Solid Tumor, Protocol Specific

Interventions: Drug: sunitinib malate
Other: pharmacological study
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Other: laboratory biomarker analysis

First Posted Date: 2006-10-13

Last Posted Date: 2014-01-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 35

Registration Number: NCT00387920

Locations: 🇨🇦
Hospital for Sick Children, Toronto, Ontario, Canada
🇺🇸
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
🇺🇸
Children's National Medical Center, Washington, District of Columbia, United States

and more 14 locations

Sunitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

Phase 2

Completed

Conditions: Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Larynx
Stage IV Squamous Cell Carcinoma of the Oropharynx
Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Squamous Cell Carcinoma of the Nasopharynx
Recurrent Squamous Cell Carcinoma of the Larynx

Interventions: Drug: sunitinib malate

First Posted Date: 2006-10-13

Last Posted Date: 2014-07-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 22

Registration Number: NCT00387335

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States

Sunitinib in Treating Patients With Idiopathic Myelofibrosis

Phase 2

Terminated

Conditions: Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Mast Cell Leukemia
Meningeal Chronic Myelogenous Leukemia
Primary Myelofibrosis
Progressive Hairy Cell Leukemia, Initial Treatment
Accelerated Phase Chronic Myelogenous Leukemia
Acute Undifferentiated Leukemia
Adult Acute Myeloid Leukemia in Remission

Interventions: Drug: sunitinib malate

First Posted Date: 2006-10-13

Last Posted Date: 2014-05-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 14

Registration Number: NCT00387426

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Sunitinib Malate in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Phase 2

Completed

Conditions: Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Stage IIIA Ovarian Epithelial Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Epithelial Cancer
Stage IV Primary Peritoneal Cavity Cancer
Stage IIIA Fallopian Tube Cancer
Stage IIIA Primary Peritoneal Cavity Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Primary Peritoneal Cavity Cancer

Interventions: Drug: sunitinib malate
Other: laboratory biomarker analysis

First Posted Date: 2006-10-13

Last Posted Date: 2015-01-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 31

Registration Number: NCT00388037

Locations: 🇨🇦
National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario, Canada

Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery

Phase 2

Active, not recruiting

Conditions: Stage III Thyroid Gland Medullary Carcinoma AJCC v7
Stage IV Thyroid Gland Papillary Carcinoma AJCC v7
Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7
Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7
Unresectable Thyroid Gland Carcinoma
Stage IV Thyroid Gland Medullary Carcinoma AJCC v7
Stage IVC Thyroid Gland Medullary Carcinoma AJCC v7
Thyroid Gland Oncocytic Carcinoma
Differentiated Thyroid Gland Carcinoma
Stage III Thyroid Gland Follicular Carcinoma AJCC v7

Interventions: Other: Laboratory Biomarker Analysis
Other: Pharmacogenomic Study
Drug: Sunitinib
Drug: Sunitinib Malate

First Posted Date: 2006-09-28

Last Posted Date: 2024-08-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 63

Registration Number: NCT00381641

Locations: 🇺🇸
Illinois CancerCare-Peoria, Peoria, Illinois, United States
🇺🇸
Southern Illinois University School of Medicine, Springfield, Illinois, United States
🇺🇸
Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States

and more 14 locations

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