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

(Peak) a Phase 3 Randomized Trial of CGT9486+Sunitinib Vs. Sunitinib in Subjects with Gastrointestinal Stromal Tumors

Phase 3

Recruiting

Conditions: Advanced Gastrointestinal Stromal Tumors
Metastatic Cancer

Interventions: Drug: CGT9486 plus sunitinib
Drug: Sunitinib
Drug: CGT9486
Drug: Midazolam

First Posted Date: 2022-01-26

Last Posted Date: 2024-12-10

Lead Sponsor: Cogent Biosciences, Inc.

Target Recruit Count: 442

Registration Number: NCT05208047

Locations: 🇮🇹
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
🇮🇹
Istituto Europeo di Oncologia, Milano, Italy
🇮🇹
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Italy

and more 122 locations

Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC

Phase 3

Active, not recruiting

Conditions: Papillary Renal Cell Carcinoma

Interventions: Drug: savolitinib
Drug: sunitinib
Drug: durvalumab

First Posted Date: 2021-09-13

Last Posted Date: 2024-12-16

Lead Sponsor: AstraZeneca

Target Recruit Count: 147

Registration Number: NCT05043090

Locations: 🇬🇧
Research Site, London, United Kingdom

Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors

Phase 1

Recruiting

Conditions: Solid Tumors
Renal Cell Carcinoma
Non-small Cell Lung Cancer
Hepatocellular Carcinoma

Interventions: Drug: Lenvatinib + Envafolimab
Drug: Sunitinib

First Posted Date: 2021-08-27

Last Posted Date: 2024-08-23

Lead Sponsor: 3D Medicines (Sichuan) Co., Ltd.

Target Recruit Count: 170

Registration Number: NCT05024214

Locations: 🇨🇳
THE First Hospital of Jilin University, Changchun, Jilin, China
🇨🇳
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
🇨🇳
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

and more 20 locations

Treatment Patterns With Targeted Therapies In Mrcc In Sweden - A Retrospective Analysis Of Data From National Registries

Completed

Conditions: Kidney Neoplasms

Interventions: Drug: sunitinib
Drug: axitinib

First Posted Date: 2020-12-16

Last Posted Date: 2024-07-19

Lead Sponsor: Pfizer

Target Recruit Count: 1205

Registration Number: NCT04669366

Locations: 🇸🇪
Pfizer Innovations AB, Sollentuna, Sweden

A Study to Assess the Efficacy and Safety of DCC-2618 and Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib

Phase 2

Completed

Conditions: Gastrointestinal Stromal Tumor(GIST)

Interventions: Drug: Ripretinib
Drug: Sunitinib

First Posted Date: 2020-11-18

Last Posted Date: 2023-03-20

Lead Sponsor: Zai Lab (Shanghai) Co., Ltd.

Target Recruit Count: 108

Registration Number: NCT04633122

Locations: 🇨🇳
The 4th Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
🇨🇳
West China Hospital of Sichuan University, Chengdu, Sichuan, China
🇨🇳
The Cancer Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

and more 15 locations

A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer

Phase 3

Active, not recruiting

Conditions: Advanced Renal Cancer

Interventions: Drug: TQB2450
Drug: Sunitinib
Drug: Anlotinib

First Posted Date: 2020-08-21

Last Posted Date: 2024-10-11

Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Target Recruit Count: 528

Registration Number: NCT04523272

Locations: 🇨🇳
The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
🇨🇳
China-Japan Friendship Hospital, Beijing, Beijing, China
🇨🇳
Peking University First Hospital, Beijing, Beijing, China

and more 23 locations

Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer

Phase 3

Active, not recruiting

Conditions: Primary Disease: Unresectable or Metastatic Renal Cell Carcinoma Focus of the Study:PFS Assessed by IRC Per RECIST 1.1

Interventions: Drug: sunitinib

First Posted Date: 2020-05-20

Last Posted Date: 2024-12-31

Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Target Recruit Count: 421

Registration Number: NCT04394975

Locations: 🇨🇳
Beijing Cancer Hospital, Beijing, China

Sunitinib Treatment on Tissue Sodium Accumulation (TSS2)

Completed

Conditions: Sodium Imbalance
Renal Cell Cancer Metastatic
Hypertension

Interventions: Drug: Sunitinib

First Posted Date: 2020-04-29

Last Posted Date: 2021-01-27

Lead Sponsor: Charite University, Berlin, Germany

Target Recruit Count: 6

Registration Number: NCT04368546

Locations: 🇩🇪
Experimental and Clinical Research Center, Clinical Research Unit, Berlin, Germany

Clinical Outcomes For Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received Sunitinib After 1st Line Immune-oncology (IO) Treatments

Completed

Conditions: Metastatic Renal Cell Carcinoma (mRCC)

Interventions: Drug: sunitinib

First Posted Date: 2019-11-25

Last Posted Date: 2023-05-03

Lead Sponsor: Pfizer

Target Recruit Count: 102

Registration Number: NCT04175262

Locations: 🇨🇦
University of Calgary, Calgary, Alberta, Canada

A Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With mRCC in Latin America (LA)

Completed

Conditions: Metastatic Renal Cell Carcinoma ( mRCC)

Interventions: Drug: Sunitinib

First Posted Date: 2019-10-03

Last Posted Date: 2022-05-10

Lead Sponsor: Pfizer

Target Recruit Count: 57

Registration Number: NCT04115189

Locations: 🇧🇷
Escola Paulista de Medicina - UNIFESP, São Paulo, Brazil
🇦🇷
Instituto Médico Especializado Alexander Fleming, Buenos Aires, Argentina
🇦🇷
Sanatorio del Salvador - Cordoba, Cordoba, Argentina

and more 4 locations

Drug Development Updates

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