Numerous clinical trials have evaluated tivozanib across phase 1, 2, and 3 studies in oncological indications such as renal cell carcinoma, hepatocellular carcinoma, biliary tract malignancies, prostate cancer, and recurrent epithelial ovarian cancer. Sponsored by pharmaceutical companies like AVEO Pharmaceuticals and Bristol-Myers Squibb, as well as academic institutions including the National Cancer Institute and Dana-Farber Cancer Institute, these trials encompass completed, recruiting, terminated, and withdrawn statuses. Examples include a recruiting phase 1/2 trial in biliary tract cancers and a completed phase 1b/2 study in metastatic renal cell carcinoma.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06661720 | RECRUITING | Clear Cell Renal Cell Carcinoma; Renal Cell Carcinoma (RCC); Stage II Renal Pelvis Cancer AJCC v8; Stage III Renal Pelvis Cancer AJCC v8 |
Alliance for Clinical Trials in Oncology |
2025-03-14 | PHASE3 |
| NCT04645160 | RECRUITING | Cholangiocarcinoma; Bile Duct Neoplasm; Biliary Tract Malignancy |
National Cancer Institute (NCI) |
2022-03-04 | PHASE1; PHASE2 |
| NCT07218692 | NOT_YET_RECRUITING | Advanced Clear Cell Renal Cell Carcinoma; Advanced Renal Cell Carcinoma; Advanced Sarcomatoid Renal Cell Carcinoma; Metastatic Clear Cell Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma; Metastatic Sarcomatoid Renal Cell Carcinoma; Recurrent Renal Cell Carcinoma; Stage III Renal Cell Cancer AJCC v8; Stage IV Renal Cell Cancer AJCC v8 |
City of Hope Medical Center |
2026-08-11 | PHASE2 |
| NCT05000294 | RECRUITING | Bile Duct Cancer; Gall Bladder Cancer; Breast Cancer; Neuroendocrine Tumors; Ovarian Cancer; Pancreatic Adenocarcinoma; Soft Tissue Sarcoma; Vulvar Cancer; Prostate Cancer |
University of Florida |
2021-12-07 | PHASE1; PHASE2 |
| NCT06053658 | RECRUITING | Renal Cell Carcinoma |
M.D. Anderson Cancer Center |
2024-01-05 | PHASE2 |
| NCT04987203 | COMPLETED | Renal Cell Carcinoma |
AVEO Pharmaceuticals, Inc. |
2021-09-09 | PHASE3 |
| NCT01885949 | TERMINATED | Prostate Cancer |
Massachusetts General Hospital |
2013-09-03 | PHASE2 |
| NCT03970616 | TERMINATED | Hepatocellular Carcinoma |
AVEO Pharmaceuticals, Inc. |
2019-09-30 | PHASE1; PHASE2 |
| NCT04645160 | Recruiting | Cholangiocarcinoma|Bile Duct Neoplasm|Biliary Tract Malignancy |
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC) |
2022-03-04 | Phase 1|Phase 2 |
| NCT01835223 | COMPLETED | Advanced Adult Hepatocellular Carcinoma; Non-Resectable Hepatocellular Carcinoma |
Roswell Park Cancer Institute |
2013-07-11 | PHASE1; PHASE2 |
| NCT02627963 | COMPLETED | Carcinoma, Renal Cell |
AVEO Pharmaceuticals, Inc. |
2016-05-24 | PHASE3 |
| NCT01853644 | COMPLETED | Recurrent Epithelial Ovarian Cancer; Recurrent Fallopian Tube Cancer; Recurrent Primary Peritoneal Cancer |
Northwestern University |
2013-06-06 | PHASE2 |
| NCT03136627 | COMPLETED | Carcinoma, Renal Cell |
AVEO Pharmaceuticals, Inc. |
2017-03-22 | PHASE1; PHASE2 |
| NCT03136627 | Completed | Carcinoma Renal Cell |
AVEO Pharmaceuticals Inc.|Bristol-Myers Squibb |
2017-03-22 | Phase 1|Phase 2 |
| NCT01728181 | WITHDRAWN | Non-small Cell Lung Cancer; Stage IV Disease; EGFR Unknown or Wild-type |
University of Utah |
2013-11 | PHASE1; PHASE2 |
| NCT01972516 | TERMINATED | Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma |
Dana-Farber Cancer Institute |
2013-11 | PHASE2 |
| NCT01369433 | TERMINATED | Solid Tumors |
AVEO Pharmaceuticals, Inc. |
2010-06 | |
| NCT01782313 | COMPLETED | Recurrent Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma |
Northwestern University |
2013-03-06 | PHASE2 |
| NCT01807156 | TERMINATED | Hepatocellular Cancer |
Emory University |
2013-03 | PHASE2 |
| NCT01846871 | COMPLETED | Glioblastoma |
Massachusetts General Hospital |
2013-06 | PHASE2 |
| NCT01076010 | COMPLETED | Advanced Renal Cell Carcinoma |
AVEO Pharmaceuticals, Inc. |
2010-03 | PHASE3 |
| NCT01745367 | TERMINATED | Triple Negative Breast Cancer |
AVEO Pharmaceuticals, Inc. |
2012-11 | PHASE2 |
| NCT01673386 | TERMINATED | Metastatic Renal Cell Carcinoma |
AVEO Pharmaceuticals, Inc. |
2012-07 | PHASE2 |
| NCT01631097 | COMPLETED | Hepatic Impairment |
AVEO Pharmaceuticals, Inc. |
2012-05 | PHASE1 |
| NCT01306630 | COMPLETED | Advanced Solid Tumors; Locally Advanced or Metastatic Breast or Colorectal Cancer |
AVEO Pharmaceuticals, Inc. |
2010-11 | PHASE1 |
| NCT01478594 | COMPLETED | Colorectal Cancer |
AVEO Pharmaceuticals, Inc. |
2011-12 | PHASE2 |
| NCT01058655 | COMPLETED | Gastrointestinal Cancer |
Dana-Farber Cancer Institute |
2010-02 | PHASE1; PHASE2 |
| NCT01769885 | WITHDRAWN | Stage II Renal Cell Cancer; Stage III Renal Cell Cancer |
Roswell Park Cancer Institute |
2013-03-14 | |
| NCT01834183 | WITHDRAWN | Renal Cell Carcinoma |
Dana-Farber Cancer Institute |
2013-06 | PHASE2 |
| NCT01853644 | Completed | Recurrent Epithelial Ovarian Cancer|Recurrent Fallopian Tube Cancer|Recurrent Primary Peritoneal Cancer |
Northwestern University|National Comprehensive Cancer Network |
2013-06-06 | Phase 2 |
| NCT01834183 | Withdrawn | Renal Cell Carcinoma |
Dana-Farber Cancer Institute |
2013-06 | Phase 2 |
| NCT01807156 | Terminated | Hepatocellular Cancer |
Emory University|AVEO Pharmaceuticals Inc. |
2013-03 | Phase 2 |
| NCT01297244 | COMPLETED | Renal Cell Carcinoma |
AVEO Pharmaceuticals, Inc. |
2011-01 | PHASE2 |
| NCT01030783 | COMPLETED | Advanced Renal Cell Carcinoma |
AVEO Pharmaceuticals, Inc. |
2009-12 | PHASE3 |
| NCT00660153 | COMPLETED | Colorectal Cancer; Gastrointestinal Cancer |
AVEO Pharmaceuticals, Inc. |
2008-06 | PHASE1 |
| NCT01363804 | COMPLETED | Healthy |
AVEO Pharmaceuticals, Inc. |
2011-05 | PHASE1 |
| NCT01363778 | COMPLETED | Healthy |
AVEO Pharmaceuticals, Inc. |
2011-05 | PHASE1 |
| NCT01316848 | COMPLETED | Food Effect of Tivozanib in Health Subjects |
AVEO Pharmaceuticals, Inc. |
2011-02 | PHASE1 |
| NCT00826878 | COMPLETED | Carcinoma, Non-Small-Cell Lung |
AVEO Pharmaceuticals, Inc. |
2009-01 | PHASE1 |
| NCT01210846 | COMPLETED | Advanced Solid Tumors |
AVEO Pharmaceuticals, Inc. |
2010-10 | PHASE1 |
| NCT00717340 | COMPLETED | Metastatic Breast Cancer |
AVEO Pharmaceuticals, Inc. |
2009-02 | PHASE1 |
| NCT00563147 | COMPLETED | Renal Cell Carcinoma |
AVEO Pharmaceuticals, Inc. |
2007-11 | PHASE1 |
| NCT00502307 | COMPLETED | Carcinoma, Renal Cell |
AVEO Pharmaceuticals, Inc. |
2007-10 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-09-02)
Check the
Tivozanib
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.