Clinical Trials

Brivanib alaninate (BMS-582664) has been evaluated in numerous clinical trials spanning Phase I through Phase III for malignancies such as hepatocellular carcinoma, advanced solid tumors, colorectal cancer, cervical carcinoma, renal cell carcinoma, and non-small cell lung cancer. These studies were sponsored by pharmaceutical companies, including Bristol-Myers Squibb and Zai Lab, as well as cooperative networks like the Gynecologic Oncology Group and NCIC Clinical Trials Group. While several clinical trials reached completion in colorectal and cervical cancers, others assessing combination therapy for advanced hepatocellular carcinoma were terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04212221 TERMINATED
Advanced Hepatocellular Carcinoma (HCC)
Zai Lab (Shanghai) Co., Ltd.
 2020-04-20 PHASE1; PHASE2
NCT03516071 COMPLETED
Hepatocellular Carcinoma (HCC)
Zai Lab (Shanghai) Co., Ltd.
 2017-05-17 PHASE2
NCT00888173 COMPLETED
Endometrial Adenocarcinoma; Endometrial Clear Cell Adenocarcinoma; Endometrial Mixed Adenocarcinoma; Endometrial Mucinous Adenocarcinoma; Endometrial Serous Adenocarcinoma; Endometrial Squamous Cell Carcinoma; Endometrial Transitional Cell Carcinoma; Endometrial Undifferentiated Carcinoma; Recurrent Uterine Corpus Carcinoma
Gynecologic Oncology Group
 2009-07-06 PHASE2
NCT00798252 COMPLETED
Advanced Cancer
Bristol-Myers Squibb
 2009-03 PHASE1
NCT01267253 COMPLETED
Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma, Not Otherwise Specified; Persistent Disease; Recurrent Cervical Carcinoma
Gynecologic Oncology Group
 2011-04-04 PHASE2
NCT01253668 TERMINATED
Renal Cell Carcinoma
Abramson Cancer Center at Penn Medicine
 2011-11 PHASE2
NCT00594984 COMPLETED
Metastatic Colorectal Cancer (MCRC)
Bristol-Myers Squibb
 2008-05 PHASE1; PHASE2
NCT00633789 COMPLETED
Advanced Non-small Cell Lung Cancer; Transitional Cell Carcinoma; Soft Tissue Sarcoma; Gastric/Esophageal Adenocarcinoma; Pancreatic Cancer Including Ampulla of Vater
Bristol-Myers Squibb
 2008-06 PHASE2
NCT00640471 COMPLETED
Colorectal Cancer
NCIC Clinical Trials Group
 2008-05-12 PHASE3
NCT00437424 COMPLETED
Carcinoma, Hepatocellular
Bristol-Myers Squibb
 2007-07 PHASE1
NCT00355238 COMPLETED
Hepatocellular Carcinoma (HCC)
Bristol-Myers Squibb
 2006-12-31 PHASE2
NCT00390936 COMPLETED
Solid Tumors
Bristol-Myers Squibb
 2007-10 PHASE1
NCT00207051 COMPLETED
Colorectal Cancer
Bristol-Myers Squibb
 2006-01 PHASE1
NCT00435669 COMPLETED
Tumors
Bristol-Myers Squibb
 2007-09 PHASE1
NCT00437437 COMPLETED
Tumors
Bristol-Myers Squibb
 2000-05 PHASE1
NCT00207103 COMPLETED
Tumors; Neoplasm Metastasis
Bristol-Myers Squibb
 2004-09 PHASE1
NCT00390936 Completed
Solid Tumors
Bristol-Myers Squibb
 2007-10 Phase 1
NCT00435669 Completed
Tumors
Bristol-Myers Squibb
 2007-09 Phase 1
NCT00437424 Completed
Carcinoma Hepatocellular
Bristol-Myers Squibb
 2007-07 Phase 1
NCT00300027 TERMINATED
Gastrointestinal Neoplasms
Bristol-Myers Squibb
 2006-04 PHASE1
NCT00437437 Completed
Tumors
Bristol-Myers Squibb
 2000-05 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-07-23)

Check the Brivanib Alaninate (BMS-582664) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Brivanib alaninate is an oral prodrug that is hydrolyzed in vivo to BMS-540215, an ATP-competitive inhibitor targeting VEGFR-1/2/3 and FGFR-1/2/3 tyrosine kinases. By blocking target phosphorylation, it inhibits downstream angiogenic signaling pathways to block endothelial cell proliferation and impair tumor neovascularization in clinical indications such as hepatocellular carcinoma and solid tumors.

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.