Clinical Trials

Dovitinib (TKI-258) has been evaluated in numerous clinical trials spanning Phase 1 through Phase 3, sponsored by pharmaceutical entities such as Novartis Pharmaceuticals and academic institutions like M.D. Anderson Cancer Center. These studies target diverse oncological indications, including advanced solid tumors, metastatic clear cell renal cancer, gastrointestinal stromal tumors, multiple myeloma, non-small cell lung cancer, and von Hippel-Lindau syndrome. The clinical landscape encompasses completed early-phase pharmacokinetic assessments, actively recruiting combination therapy trials, and several terminated or withdrawn single-agent or combination protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05571969 TERMINATED
Advanced Solid Tumors
Allarity Therapeutics
 2023-03-08 PHASE1
NCT05571969 Recruiting
Advanced Solid Tumors
Allarity Therapeutics|Amarex Clinical Research
 2023-02-20 Phase 1
NCT00831792 COMPLETED
Prostate Cancer
M.D. Anderson Cancer Center
 2010-04-07 PHASE2
NCT01994590 TERMINATED
Prostate Cancer
M.D. Anderson Cancer Center
 2014-05-19 PHASE2
NCT01732107 TERMINATED
Bladder Cancer
Noah Hahn, M.D.
 2013-03 PHASE2
NCT02116803 COMPLETED
Solid Tumors
Novartis Pharmaceuticals
 2014-05-28 PHASE2; PHASE3
NCT01972750 UNKNOWN
First or Second Recurrence of Glioblastoma
PD Dr. Martin Glas
 2013-10 PHASE1
NCT02268435 WITHDRAWN
Gastrointestinal Stromal Tumors
Asan Medical Center
 2015-03 PHASE1
NCT01921673 COMPLETED
Gastric Cancer
Asan Medical Center
 2013-08 PHASE1; PHASE2
NCT01635907 COMPLETED
Advanced Metastatic Paraganglioma; Advanced Metastatic Pheochromocytoma; Recurrent Paraganglioma; Recurrent Pheochromocytoma; Unresectable Paraganglioma; Unresectable Pheochromocytoma
Abramson Cancer Center at Penn Medicine
 2012-06 PHASE2
NCT01719549 COMPLETED
Gastric Cancer
Asan Medical Center
 2012-09 PHASE2
NCT01676714 COMPLETED
Non-Small Cell Lung Cancer; Colorectal Cancer
University of California, Davis
 2013-02 PHASE2
NCT01831726 COMPLETED
Tumor Pathway Activations Inhibited by Dovitinib
Novartis Pharmaceuticals
 2013-08 PHASE2
NCT01266070 TERMINATED
Von Hippel-Lindau Syndrome
M.D. Anderson Cancer Center
 2012-11 PHASE2
NCT01484041 TERMINATED
Breast Cancer
Georgetown University
 2012-04 PHASE1; PHASE2
NCT01262027 COMPLETED
Breast Cancer
M.D. Anderson Cancer Center
 2012-01-27 PHASE2
NCT02048943 WITHDRAWN
Duct Cell Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
Roswell Park Cancer Institute
 2015-03 PHASE1
NCT01678105 COMPLETED
Recurrent Adenoid Cystic Carcinoma of the Salivary Glands; Metastatic Adenoid Cystic Carcinoma of the Salivary Glands; Salivary Gland Cancers; ACC
Ontario Clinical Oncology Group (OCOG)
 2012-11 PHASE2
NCT01497392 COMPLETED
Adenocarcinoma of the Pancreas; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
Roswell Park Cancer Institute
 2012-03-29 PHASE1
NCT01769547 TERMINATED
Advanced Malignant Pleural Mesothelioma; MPM
Ontario Clinical Oncology Group (OCOG)
 2013-03 PHASE2
NCT01791387 UNKNOWN
Clear Cell Renal Cell Carcinoma
Auckland District Health Board
 2012-03 PHASE2
NCT02108782 WITHDRAWN
Gastrinoma; Glucagonoma; Insulinoma; Pancreatic Polypeptide Tumor; Recurrent Islet Cell Carcinoma; Somatostatinoma
Academic and Community Cancer Research United
 2014-10 PHASE2
NCT01528345 TERMINATED
Metastatic Breast Cancer
Novartis Pharmaceuticals
 2012-04 PHASE2
NCT02268435 Withdrawn
Gastrointestinal Stromal Tumors
Asan Medical Center
 2015-03 Phase 1
NCT01753713 COMPLETED
Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor
Manmeet Ahluwalia, MD
 2012-12-20 PHASE2
NCT01861197 UNKNOWN
Squamous NSCLC
Samsung Medical Center
 2013-03 PHASE2
NCT01741116 COMPLETED
Hormone Refractory Prostate Cancer
Korean Cancer Study Group
 2012-11 PHASE2
NCT01443481 COMPLETED
Solid Tumors; Hepatic Impairment
Novartis Pharmaceuticals
 2011-11 PHASE1
NCT01964144 COMPLETED
Thyroid Cancer
Yonsei University
 2013-01 PHASE2
NCT01700270 COMPLETED
Advanced Solid Tumors, Excluding Breast Cancer
Novartis Pharmaceuticals
 2013-05 PHASE1
NCT01888965 TERMINATED
Colorectal Cancer; Pancreas Cancer
Georgetown University
 2013-10 PHASE2
NCT02065323 WITHDRAWN
Prostate Cancer
Oscar Goodman, Jr.
 PHASE2
NCT01478373 COMPLETED
Gastrointestinal Stromal Tumors
Novartis Pharmaceuticals
 2012-01 PHASE2
NCT01596647 COMPLETED
Advanced Solid Tumors, Excluding Breast Cancer
Novartis Pharmaceuticals
 2012-05 PHASE1
NCT01421004 COMPLETED
Advanced Solid Tumors; Excluding Breast Cancer
Novartis Pharmaceuticals
 2011-12 PHASE1
NCT01223027 COMPLETED
Metastatic Renal Cell Carcinoma
Novartis Pharmaceuticals
 2011-03 PHASE3
NCT01232296 COMPLETED
Hepatocellular Carcinoma
Novartis Pharmaceuticals
 2011-07 PHASE2
NCT01379534 COMPLETED
Solid Tumors and Advanced Endometrial Cancer; Endometrial Cancer; Second-line Treatment; VEGF
Novartis Pharmaceuticals
 2011-11 PHASE2
NCT01524692 COMPLETED
Adenoid Cystic Carcinoma
University of Virginia
 2012-03 PHASE2
NCT01417143 COMPLETED
Adenoid Cystic Carcinoma
Seoul National University Hospital
 2011-09 PHASE2
NCT01155713 COMPLETED
Neoplasm; Cancer; Tumors
Novartis Pharmaceuticals
 2010-07 PHASE1
NCT01576380 COMPLETED
Adenocarcinoma, Scirrhous; Linitis Plastica; Stomach Neoplasms; Stomach Diseases; Neoplasms by Site; Neoplasms
Novartis Pharmaceuticals
 2012-06 PHASE2
NCT01496534 TERMINATED
Solid Tumors; Bladder Cancer
Matthew Galsky
 2012-01 PHASE1
NCT01514526 COMPLETED
Adrenocortical Carcinoma
Spanish Oncology Genito-Urinary Group
 2012-01 PHASE2
NCT01700270 Completed
Advanced Solid Tumors Excluding Breast Cancer
Novartis Pharmaceuticals|Novartis
 2013-05 Phase 1
NCT01440959 COMPLETED
Gastrointestinal Stromal Tumors
Asan Medical Center
 2011-09 PHASE2
NCT01515969 TERMINATED
Non-small Cell Lung Cancer (NSCLC), Recurrent; Non-small Cell Lung Cancer (NSCLC), Stage IV
Heather Wakelee
 2012-07 PHASE1
NCT01548924 TERMINATED
Solid Tumors
Centro Nacional de Investigaciones Oncologicas CARLOS III
 2012-04 PHASE1
NCT01680796 WITHDRAWN
Multiple Myeloma
University of Florida
 2013-02 PHASE1
NCT01058434 COMPLETED
Relapsed or Refractory Multiple Myeloma
Novartis Pharmaceuticals
 2010-05 PHASE2
NCT01680796 Withdrawn
Multiple Myeloma
University of Florida|Novartis Pharmaceuticals
 2013-02 Phase 1
NCT01266070 Terminated
Von Hippel-Lindau Syndrome
M.D. Anderson Cancer Center|Novartis
 2012-11 Phase 2
NCT01714765 COMPLETED
Metastatic Clear Cell Renal Cancer
Queen Mary University of London
 2011-04 PHASE1
NCT00715182 COMPLETED
Advanced/ Metastatic Renal Cell Cancer
Novartis Pharmaceuticals
 2008-07 PHASE1
NCT01030055 COMPLETED
Neoplasms; Cancer; Tumors
Novartis Pharmaceuticals
 2010-02 PHASE1
NCT01471548 COMPLETED
Advanced Solid Tumors
Novartis Pharmaceuticals
 2008-09 PHASE1
NCT00790426 COMPLETED
Urothelial Cancer
Novartis Pharmaceuticals
 2010-03 PHASE2
NCT02720926 TERMINATED
Colorectal Cancer; Gastric Cancer
National Cancer Centre, Singapore
 2011-09 PHASE1
NCT00958971 COMPLETED
Metastatic Breast Cancer
Novartis Pharmaceuticals
 2009-07 PHASE2
NCT00669097 COMPLETED
Advanced Solid Malignancies
Novartis Pharmaceuticals
 2008-04 PHASE1
NCT00303251 COMPLETED
Melanoma
Novartis Pharmaceuticals
 2006-04 PHASE1; PHASE2
NCT00279773 TERMINATED
Acute Myeloid Leukemia
Novartis Pharmaceuticals
 2004-09 PHASE1
NCT01270906 TERMINATED
Neoplasms; Cancer; Tumors
Novartis Pharmaceuticals
 2003-12 PHASE1
NCT00243763 TERMINATED
Multiple Myeloma
Novartis
 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-01)

Check the Dovitinib (TKI-258) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dovitinib binds potently to class III, IV, and V receptor tyrosine kinases including FLT3, c-KIT, FGFR, and VEGFR, thereby inhibiting receptor autophosphorylation and downstream ERK1/2 signaling cascades to suppress cell proliferation and induce cytotoxicity. By disrupting these essential pro-angiogenic and oncogenic pathways, this multi-kinase blockade halts tumor vascularization and cell survival, providing therapeutic rationale for its clinical investigation in advanced solid tumors, renal cell carcinoma, and non-small cell lung cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.