TKI258

(Dovitinib)

Phase 3Small molecule

Dovitinib is used to treat certain types of cancer, particularly advanced renal cell carcinoma (kidney cancer) and other cancers where specific protein signals that help cancer cells grow need to be blocked.[1] TKI258 is currently being investigated across 28 indications[3], with its most advanced program in Phase 3.[1]

TKI258 is one of 586 small molecule programs targeting Clear Cell Renal Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

585

Competitors

Pipeline

Status by Indication[3][1]

Indication

Clear Cell Renal CarcinomaActive, not recruiting

Malignant Pleural MesotheliomaActive, not recruiting

Adenoid Cystic CarcinomaActive, not recruiting

Urogenital NeoplasmActive, not recruiting

Adrenal Gland PheochromocytomaActive, not recruiting

Von Hippel-Lindau DiseaseActive, not recruiting

Adult GlioblastomaActive, not recruiting

Triple-Negative Breast CancerActive, not recruiting

GliosarcomaActive, not recruiting

Adrenal Cortex CarcinomaActive, not recruiting

Clear Cell Renal CarcinomaPhase 2

Active, not recruiting

Malignant Pleural MesotheliomaPhase 2

Active, not recruiting

Adenoid Cystic CarcinomaPhase 2

Active, not recruiting

Urogenital NeoplasmPhase 2

Active, not recruiting

Adrenal Gland PheochromocytomaPhase 2

Active, not recruiting

Von Hippel-Lindau DiseasePhase 2

Active, not recruiting

Adult GlioblastomaPhase 2

Active, not recruiting

Triple-Negative Breast CancerPhase 2

Active, not recruiting

GliosarcomaPhase 2

Active, not recruiting

Adrenal Cortex CarcinomaPhase 2

Active, not recruiting

Showing 10 of 28 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

TKI258

Novartis

Phase 3

3 2

Tecentriq

Roche

Preclinical

36 3

Adriamycin

GGynecologic Oncology Group

Preclinical

87 4

Avastin

BBio-Thera Solutions

Preclinical

153 5

Gemzar

GGynecologic Oncology Group

Preclinical

22 6

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 7

Voltaren

Novartis

Preclinical

1 8

Zolymbus

AbbVie

Preclinical

1 9

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 10

Spravato

WWim Janssens

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Breast Cancer3 trials

Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer

Terminated· Novartis logo

Novartis·Phase 2·NCT01528345·97 enrolled

TKI258 for Metastatic Inflammatory Breast Cancer Patients

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01262027·22 enrolled

Dovitinib Plus an Aromatase Inhibitor for Metastatic Breast Cancer

Terminated·GGeorgetown University·Phase 1/2·NCT01484041·12 enrolled

Patients With Solid Tumors2 trials

Determination of Dose of Antiangiogenic Multitargeted DOVITINIB (TKI258) Plus Paclitaxel in Patients With Solid Tumors

Terminated·CCentro Nacional de Investigaciones Oncologicas CARLOS III·Phase 1·NCT01548924·13 enrolled

An Open Label Multi-center Extension Study to Evaluate Long-term Safety/ Tolerability of Dovitinib in Patients With Solid Tumors Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored Single Agent Dovitinib Studies Which Fulfilled the Requirements for the Primary Objective

Completed· Novartis logo

Novartis·Phase 2/3·NCT02116803·12 enrolled

Non-Small Cell Lung Cancer2 trials

Phase II Study of Dovitinib for FGFR1 Amplified Squamous Non-small Cell Lung Cancer

Unknown status·SSamsung Medical Center·Phase 2·NCT01861197·27 enrolled

Study of Dovitinib and Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer

Completed·UUniversity of California, Davis·Phase 2·NCT01676714·10 enrolled

Adenoid Cystic Carcinoma2 trials

A Phase II Study of Dovitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands

Completed·OOntario Clinical Oncology Group (OCOG)·Phase 2·NCT01678105·21 enrolled

Study of Dovitinib (TKI258) in Adenoid Cystic Carcinoma

Completed·UUniversity of Virginia·Phase 2·NCT01524692·35 enrolled

Glioblastoma2 trials

Dovitinib (TKI258) in the Treatment of Patients With Relapsed Glioblastoma

Unknown status·PPD Dr. Martin Glas·Phase 1·NCT01972750·12 enrolled

Dovitinib in Treating Patients With Recurrent or Progressive Glioblastoma

Completed·—·Phase 2·NCT01753713·33 enrolled

19 more indications

Gastrointestinal Stromal Tumor2 trials

Dovitinib for Imatinib/Sumitinib-failed Gastrointestinal Stromal Tumors (GIST): TKI258

Completed·—·Phase 2·NCT01440959·30 enrolled

Efficacy and Safety of Dovitinib in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib

Completed· Novartis logo

Novartis·Phase 2·NCT01478373·39 enrolled

Prostate Cancer1 trial

Dovitinib (TKI258) and Abiraterone Acetate in Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT01994590·4 enrolled

Hepatic Function1 trial

Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function

Completed· Novartis logo

Novartis·Phase 1·NCT01443481·38 enrolled

Pancreas Cancer1 trial

Maintenance Dovitinib for Colorectal and Pancreas Cancer

Terminated·GGeorgetown University·Phase 2·NCT01888965·9 enrolled

Malignant Pleural Mesothelioma1 trial

A Phase II Study of Single-agent DOVitinib in Advanced Malignant PlEural Mesothelioma Which Has Progressed Following Prior Platinum-Antifolate Chemotherapy

Terminated·OOntario Clinical Oncology Group (OCOG)·Phase 2·NCT01769547·12 enrolled

RCC1 trial

1st-line Activity of Dovitinib and Correlation With Genetic Changes in RCC

Unknown status·AAuckland District Health Board·Phase 2·NCT01791387·30 enrolled

Clear Cell Renal Cancer1 trial

Dose Escalation Study Investigating Everolimus and Dovitinib in Metastatic Clear Cell Renal Cancer

Completed·QQueen Mary University of London·Phase 1·NCT01714765·17 enrolled

Urothelial Carcinoma1 trial

Dovitinib in BCG Refractory Urothelial Carcinoma With FGFR3 Mutations or Over-expression

Terminated·NNoah Hahn, M.D.·Phase 2·NCT01732107·13 enrolled

Adrenocortical Carcinoma1 trial

Clinical Trial of Dovitinib in First-line Metastatic or Locally Advanced Non-resectable Adrenocortical Carcinoma

Completed·SSpanish Oncology Genito-Urinary Group·Phase 2·NCT01514526·17 enrolled

Renal Cell Carcinoma1 trial

Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma

Completed· Novartis logo

Novartis·Phase 3·NCT01223027·564 enrolled

Metastatic Prostate Cancer1 trial

A Study of Dovitinib With Androgen Deprivation Therapy (ADT) in Patients With Metastatic Prostate Cancer Receiving Primary ADT

Withdrawn·OOscar Goodman, Jr.·Phase 2·NCT02065323

Gastric Cancer1 trial

Dovitinib for Gastric Cancer With FGFR2 Amplification: GASDOVI-1

Completed·—·Phase 2·NCT01719549·19 enrolled

Thyroid Cancer1 trial

An Open-label, Multicenter, Phase II Study of Dovitinib in Advanced Thyroid Cancer

Completed·YYonsei University·Phase 2·NCT01964144·40 enrolled

Multiple Myeloma1 trial

Dovitinib Combined With Bortezomib and Dexamethasone for Relapsed/Refractory Multiple Myeloma

Withdrawn·UUniversity of Florida·Phase 1·NCT01680796

Hepatocellular Carcinoma1 trial

A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment

Completed· Novartis logo

Novartis·Phase 2·NCT01232296·162 enrolled

Neuroendocrine Tumors1 trial

Dovitinib in Neuroendocrine Tumors

Completed·—·Phase 2·NCT01635907·8 enrolled

Von Hippel-Lindau Syndrome1 trial

TKI 258 in Von Hippel-Lindau Syndrome (VHL)

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT01266070·6 enrolled

Tumor1 trial

Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib

Completed· Novartis logo

Novartis·Phase 2·NCT01831726·80 enrolled

Patients With Advanced Solid Tumors1 trial

Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors.

Completed· Novartis logo

Novartis·Phase 1·NCT01700270·45 enrolled

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Dovitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dovitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dovitinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Fibroblast Growth Factor Receptor 3 Inhibitor; Platelet-Derived Growth Factor Receptor Inhibitor; Stem Cell Growth Factor Receptor Inhibitor; Tyrosine-Protein Kinase Receptor FLT3 Inhibitor; Vascular Endothelial Growth Factor Receptor Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Novartis

TKI258

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Breast Cancer3 trials

Patients With Solid Tumors2 trials

Non-Small Cell Lung Cancer2 trials

Adenoid Cystic Carcinoma2 trials

Glioblastoma2 trials

Gastrointestinal Stromal Tumor2 trials

Prostate Cancer1 trial

Hepatic Function1 trial

Pancreas Cancer1 trial

Malignant Pleural Mesothelioma1 trial

RCC1 trial

Clear Cell Renal Cancer1 trial

Urothelial Carcinoma1 trial

Adrenocortical Carcinoma1 trial

Renal Cell Carcinoma1 trial

Metastatic Prostate Cancer1 trial

Gastric Cancer1 trial

Thyroid Cancer1 trial

Multiple Myeloma1 trial

Hepatocellular Carcinoma1 trial

Neuroendocrine Tumors1 trial

Von Hippel-Lindau Syndrome1 trial

Tumor1 trial

Patients With Advanced Solid Tumors1 trial

References

Drug Info

Quick Facts

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