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 formul...

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

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

Phase 2

Active, not recruiting

Conditions: Advanced Malignant Solid Neoplasm
Breast Carcinoma
Cervical Carcinoma
Liver Carcinoma
Malignant Uterine Neoplasm
Recurrent Gastric Carcinoma
Recurrent Head and Neck Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Prostate Carcinoma
Recurrent Rectal Carcinoma

Interventions: Drug: Afatinib
Drug: Capivasertib
Drug: Binimetinib
Drug: Adavosertib
Procedure: Biospecimen Collection
Other: Cytology Specimen Collection Procedure
Drug: Afatinib Dimaleate
Drug: Dabrafenib
Drug: Defactinib
Drug: Fexagratinib
Drug: Dasatinib
Drug: Ipatasertib
Procedure: Biopsy
Drug: Crizotinib
Drug: Dabrafenib Mesylate
Drug: Taselisib
Drug: Sapanisertib
Drug: PI3K-beta Inhibitor GSK2636771
Drug: Defactinib Hydrochloride
Drug: Palbociclib
Biological: Nivolumab
Drug: Copanlisib
Drug: Ulixertinib
Biological: Trastuzumab Emtansine
Drug: Copanlisib Hydrochloride
Biological: Relatlimab
Procedure: Computed Tomography
Drug: Trametinib
Biological: Pertuzumab
Drug: Erdafitinib
Procedure: Radiologic Examination
Procedure: Multigated Acquisition Scan
Drug: Larotrectinib
Procedure: Echocardiography
Drug: Osimertinib
Biological: Trastuzumab
Drug: Larotrectinib Sulfate
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Drug: Vismodegib
Drug: Sunitinib Malate
Procedure: Radionuclide Imaging

First Posted Date: 2015-06-08

Last Posted Date: 2024-12-19

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 6452

Registration Number: NCT02465060

Locations: 🇺🇸
Alaska Women's Cancer Care, Anchorage, Alaska, United States
🇺🇸
Anchorage Oncology Centre, Anchorage, Alaska, United States
🇺🇸
Katmai Oncology Group, Anchorage, Alaska, United States

and more 1416 locations

Single-arm Study to Evaluate the Safety and Efficacy of Sunitinib, in Subjects With RET Fusion Positive or FGFR2 Amplification, Refractory Solid Tumors

Not Applicable

Completed

Conditions: Refractory Solid Tumors

Interventions: Drug: sunitinib

First Posted Date: 2015-05-21

Last Posted Date: 2022-06-15

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 1

Registration Number: NCT02450123

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

Isoquercetin as an Adjunct Therapy in Patients With Kidney Cancer Receiving First-line Sunitinib: a Phase I/II Trial

Phase 1

Conditions: Kidney Cancer
Renal Cell Carcinoma

Interventions: Drug: Sunitinib
Drug: Placebo
Drug: Isoquercetin

First Posted Date: 2015-05-18

Last Posted Date: 2017-01-18

Lead Sponsor: Consorzio Oncotech

Target Recruit Count: 104

Registration Number: NCT02446795

Locations: 🇮🇹
Ospedale Oncologico Regionale - Centro di Riferimento Oncologico di Basilicata U.O. di Oncologia Medica, Rionero in vulture, Potenza, Italy
🇮🇹
Fondazione G. Pascale, Naples, Italy
🇮🇹
University Federico II of Naples, Naples, Italy

and more 2 locations

Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC)

Phase 2

Completed

Conditions: Renal Cell Carcinoma, Metastatic

Interventions: Drug: Sunitinib

First Posted Date: 2015-05-04

Last Posted Date: 2022-08-22

Lead Sponsor: Mendus

Target Recruit Count: 88

Registration Number: NCT02432846

Locations: 🇵🇱
Military Institute of Medicine, Warsaw, Poland
🇺🇸
Rush University, Chicago, Illinois, United States
🇺🇸
University of Illinois, Chicago, Illinois, United States

and more 25 locations

A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)

Phase 3

Completed

Conditions: Renal Cell Carcinoma

Interventions: Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Drug: Sunitinib
Drug: Bevacizumab

First Posted Date: 2015-04-20

Last Posted Date: 2023-01-30

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 915

Registration Number: NCT02420821

Locations: 🇺🇸
Lynn Cancer Institute/Boca Raton Regional Hospital, Boca Raton, Florida, United States
🇺🇸
Florida Cancer Specialists - Port Charlotte, Port Charlotte, Florida, United States
🇺🇸
Texas Oncology-Baylor Sammons Cancer Center, Dallas, Texas, United States

and more 151 locations

CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors

Phase 1

Completed

Conditions: Gastrointestinal Stromal Tumors

Interventions: Drug: PLX9486
Drug: Sunitinib
Drug: Pexidartinib

First Posted Date: 2015-03-30

Last Posted Date: 2021-05-04

Lead Sponsor: Cogent Biosciences, Inc.

Target Recruit Count: 51

Registration Number: NCT02401815

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
OSU Comprehensive Cancer Center, Columbus, Ohio, United States

and more 3 locations

A Phase II Trial of Sunitinib and Nivolumab for KIT-mutated Advanced Melanoma

Phase 2

Withdrawn

Conditions: Melanoma

Interventions: Drug: sunitinib
Drug: nivolumab

First Posted Date: 2015-03-27

Last Posted Date: 2017-02-01

Lead Sponsor: California Pacific Medical Center Research Institute

Registration Number: NCT02400385

Locations: 🇺🇸
California Pacific Medical Center Research Institute, San Francisco, California, United States

A Phase II Trila of Sunitinib Schedule 4/2 vs. Shedule 2/1 as First Line Therapy in Metastatic Renal Cell Carcinoma.

Phase 2

Conditions: Metastatic Renal Cell Carcinoma

Interventions: Drug: Sunitinib

First Posted Date: 2015-03-25

Last Posted Date: 2016-03-01

Lead Sponsor: Peking University Cancer Hospital & Institute

Target Recruit Count: 80

Registration Number: NCT02398552

Locations: 🇨🇳
Tianjin medical university cancer institute & hospital, Tianjin, Tianjin, China
🇨🇳
Chinese acadamy of medical science cancer institute & hospital, Beijing, Beijing, China
🇨🇳
Sun Yat-sen university cancer center, Guangzhou, Guangdong, China

and more 3 locations

Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery

Phase 2

Terminated

Conditions: Neuroendocrine Tumors
Neuroendocrine Neoplasms
Carcinoma, Neuroendocrine
Neuroendocrine Carcinoma
Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas

Interventions: Drug: Sunitinib
Drug: Everolimus

First Posted Date: 2014-12-12

Last Posted Date: 2020-09-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 16

Registration Number: NCT02315625

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors

Completed

Conditions: Pancreatic Neuroendocrine Tumors

Interventions: Drug: sunitinib

First Posted Date: 2014-11-04

Last Posted Date: 2024-06-20

Lead Sponsor: Pfizer

Target Recruit Count: 100

Registration Number: NCT02282059

Locations: 🇨🇳
The Affiliated Tumour Hospital of Harbin Medical University, Haerbin, Heilongjiang, China
🇨🇳
Eastern Theater General Hospital,QinHuai District Medical Area, Nanjing, Jiangsu, China
🇨🇳
Air Force Medical University, Xi'an, Shanxi, China

and more 21 locations

Drug Development Updates

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