Drugs / Tivozanib
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Tivozanib

Small molecule targets KIT, PDGFRB via inhibition

Developed for
renal cell carcinoma · cancer · breast cancer · clear cell renal carcinoma · colorectal cancer · fallopian tube cancer · hepatocellular carcinoma · non-small cell lung carcinoma
+16 more · ovarian cancer · primary peritoneal carcinoma · prostate cancer · soft tissue sarcoma · adult hepatocellular carcinoma · bile duct cancer · cholangiocarcinoma · digestive system cancer · gallbladder cancer · glioblastoma · malignant epithelial tumor of ovary · neuroendocrine neoplasm · pancreatic adenocarcinoma · renal pelvis carcinoma · triple-negative breast carcinoma · vulva cancer
Investigated by
AVEO Pharmaceuticals, Inc. · National Comprehensive Cancer Network · Dana-Farber Cancer Institute · Massachusetts General Hospital · National Cancer Institute (NCI) · Astellas Pharma Inc
+17 more · Bristol-Myers Squibb · Northwestern University · Roswell Park Cancer Institute · Alliance for Clinical Trials in Oncology · AstraZeneca · Aveo Oncology Pharmaceuticals · Beth Israel Deaconess Medical Center · Brigham and Women's Hospital · City of Hope Medical Center · Emory University · Genentech, Inc. · Kyowa Kirin, Inc. · M.D. Anderson Cancer Center · Novartis · Parexel · University of Florida · University of Utah

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) FOTIVDA 2021-03-10 fda.gov
Approved EU (EMA) Fotivda 2017-08-24 europa.eu

Trials 39 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 111 trials
Phase 1 NCT01631097 May 2012 → Jan 2014 AVEO Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT01363804 May → Jul 2011 AVEO Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT01363778 May → Jul 2011 AVEO Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT01316848 Feb → May 2011 AVEO Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT01306630 Nov 2010 → Jan 2014 cancer AVEO Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT01210846 Oct 2010 → Mar 2011 cancer AVEO Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT00970411 Aug 2009 → Apr 2016 cancer Kyowa Kirin, Inc. Completed No outcome recorded
Phase 1 NCT00717340 Feb 2009 → Jan 2011 breast cancer AVEO Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT00826878 Jan 2009 → Mar 2011 non-small cell lung carcinoma AVEO Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT00660153 Jun 2008 → Jun 2012 colorectal cancer AVEO Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1/27 trials
Phase 1/2 NCT04645160 Mar 2022 → Dec 2028 expected cholangiocarcinoma National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 1/2 NCT05000294 Dec 2021 → Dec 2026 expected bile duct cancer, breast cancer, gallbladder cancer, neuroendocrine neoplasm +5 University of Florida Recruiting No outcome recorded
Phase 1/2 NCT03970616 Sep 2019 → Apr 2023 hepatocellular carcinoma AVEO Pharmaceuticals, Inc. Terminated No outcome recorded
Phase 1/2 NCT03136627 Mar → Dec 2017 renal cell carcinoma AVEO Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1/2 NCT01728181 Nov 2013 → Mar 2016 non-small cell lung carcinoma University of Utah Withdrawn No outcome recorded
Phase 1/2 NCT01835223 Jul 2013 → Dec 2018 adult hepatocellular carcinoma Roswell Park Cancer Institute Completed No outcome recorded
Phase 1/2 NCT01058655 Feb 2010 → Sep 2013 digestive system cancer Dana-Farber Cancer Institute Completed No outcome recorded
Phase 214 trials
Phase 2 NCT07218692 Aug 2026 → Aug 2027 expected clear cell renal carcinoma, sarcomatoid renal cell carcinoma City of Hope Medical Center Not yet recruiting No outcome recorded
Phase 2 NCT06053658 Jan 2024 → Nov 2026 expected renal cell carcinoma M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT01972516 Nov 2013 → Jul 2015 fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma Dana-Farber Cancer Institute Terminated No outcome recorded
Phase 2 NCT01885949 Sep 2013 → May 2024 prostate cancer Massachusetts General Hospital Terminated No outcome recorded
Phase 2 NCT01853644 Jun 2013 → Oct 2018 fallopian tube cancer, malignant epithelial tumor of ovary, primary peritoneal carcinoma Northwestern University Completed No outcome recorded
Phase 2 NCT01846871 Jun 2013 → Sep 2014 glioblastoma Massachusetts General Hospital Completed No outcome recorded
Phase 2 NCT01834183 Jun 2013 renal cell carcinoma Dana-Farber Cancer Institute Withdrawn No outcome recorded
Phase 2 NCT01782313 Mar 2013 → May 2015 soft tissue sarcoma Northwestern University Completed No outcome recorded
Phase 2 NCT01807156 Mar 2013 → Feb 2015 hepatocellular carcinoma Emory University Terminated No outcome recorded
Phase 2 NCT01745367 Nov 2012 → Jun 2014 triple-negative breast carcinoma AVEO Pharmaceuticals, Inc. Terminated No outcome recorded
Phase 35 trials
Phase 3 NCT06661720 Mar 2025 → Nov 2037 expected clear cell renal carcinoma, renal pelvis carcinoma Alliance for Clinical Trials in Oncology Recruiting No outcome recorded
Phase 3 NCT04987203 Sep 2021 → Jan 2026 renal cell carcinoma AVEO Pharmaceuticals, Inc. Completed No outcome recorded
Phase 3 NCT02627963 May 2016 → Oct 2018 renal cell carcinoma AVEO Pharmaceuticals, Inc. Completed No outcome recorded
Phase 3 NCT01076010 Mar 2010 → Jul 2014 renal cell carcinoma AVEO Pharmaceuticals, Inc. Completed No outcome recorded
Phase 3 NCT01030783 Dec 2009 → Jul 2012 renal cell carcinoma AVEO Pharmaceuticals, Inc. Completed No outcome recorded
Phase not applicable2 trials
NCT01769885 Mar → Jun 2013 renal cell carcinoma Roswell Park Cancer Institute Withdrawn No outcome recorded
NCT01369433 Jun 2010 → Jun 2015 cancer AVEO Pharmaceuticals, Inc. Terminated No outcome recorded

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 42 sources stand behind the page.

FieldValueCited text
Known as Tivozanib ClinicalTrials.gov intervention name — accepted as the source's own label NCT01076010
37

NCT00563147

NCT01297244

NCT04987203

NCT03136627

NCT01210846

NCT01369433

NCT01782313

NCT01673386

NCT06661720

NCT01885949

NCT02627963

NCT01478594

NCT00660153

NCT01972516

NCT04645160

NCT00826878

NCT00502307

NCT01745367

NCT01058655

NCT03970616

NCT01807156

NCT06053658

NCT01846871

NCT01769885

NCT01853644

NCT05000294

NCT01363804

NCT01835223

NCT00717340

NCT01316848

NCT01631097

NCT01306630

NCT01363778

NCT07218692

NCT01834183

NCT01728181

NCT01030783

Known as (tivozanib hydrochloride hydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494
Known as ASP-4130 ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494
Known as AV-951 “Thereafter in the Phase 1b and 2a study, subjects will receive tivozanib (AV-951) once daily for 3 weeks beginning on Day 1, followed by 1 week off treatment (1 cycle = 4 weeks).” NCT00717340
8

“This phase 2 trial is evaluating the antineoplastic activity of tivozanib (AV-951) in treating patients with recurrent or metastatic renal cell cancer.” NCT00502307

“The purpose of this study is to test the safety and tolerability of tivozanib (AV-951) and Torisel™ given in combination for renal cell cancer.” NCT00563147

“Subjects will receive 0.5 mg, 1.0 mg or 1.5 mg of tivozanib (AV-951) once daily for 3 weeks, followed by 1 week off.” NCT01369433

“Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers” NCT04645160

“Tivozanib (AV-951): 0.5 mg, 1.0 mg, and 1.5 mg oral once daily” NCT00660153

“Drug: Tivozanib (AV-951)” NCT00826878

“Drug: tivozanib (AV-951)” NCT01030783

“tivozanib (AV-951)” NCT01306630

Known as DC-001164TIVOZANIBAV9511-(2-CHLORO-4((6,7-DIMETHOXYQUINOLIN-4-YL)OXY)PHENYL)-3-(5-METHYLISOXAZO-3-YL)UREA ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494
Known as FOTIVDA ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494
Known as KIL-8951 ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494
Known as KRN951 “Tivozanib hydrochloride (tivozanib; previously known as AV-951 and as KRN951) has the chemical name” NCT03136627
1

NCT00970411

Known as OPHTHOTECH ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494
Known as TIVOZANIB (AV-951) ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494
Known as TIVOZANIB (OPHTHALMIC) ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494
Known as TIVOZANIB HCL ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494
Known as Tivozanib hydrochloride Tivozanib hydrochloride (tivozanib) is a potent and selective tyrosine kinase inhibitor of all 3 vascular endothelial growth factor receptors with antitumor activity additive...” PMID 25591799 Dec 2014
2

Tivozanib hydrochloride (tivozanib; previously known as AV-951 and as KRN951) has the chemical name” NCT03136627

“Participants randomized to this arm will receive the study drug, tivozanib hydrochloride.” NCT02627963

Known as Tivozanib hydrochloride monohydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494
Action Inhibit “Tivozanib (AV-951) is a VEGF-receptor tyrosine kinase inhibitor, and may stop the growth of tumor cells by blocking blood flow to the tumor.” NCT00502307
2

“Platelet-derived growth factor receptor beta inhibitor” CHEMBL1289494

“Stem cell growth factor receptor inhibitor” CHEMBL1289494

Modality Small molecule “Tivozanib is a potent small molecule tyrosine kinase inhibitor against VEGFR1-3” PMID 27771610 Jan 2017
Route Oral “solid oral dosage form taken daily for three weeks per one month cycle” NCT00502307
Target KIT “Stem cell growth factor receptor inhibitor” CHEMBL1289494
Target PDGFRB “Platelet-derived growth factor receptor beta inhibitor” CHEMBL1289494