Golvatinib (E7050) Clinical Trials

Size	Price	Qty
5mg	USD 270
1g	USD 3,990

Clinical Trials

Numerous Phase 1 and Phase 2 clinical trials, primarily sponsored by Eisai Inc. alongside collaborators such as Quintiles Inc. and PharmaBio Development Inc., have evaluated Golvatinib (E7050). These studies assessed healthy subject pharmacokinetics as well as treatments for oncology indications including advanced solid tumors, untreated gastric cancer, hepatocellular carcinoma, and head and neck cancer. While trials evaluating pharmacokinetic profiles and combination therapies with cetuximab or sorafenib were completed, others involving gastric cancer and advanced solid tumors were terminated prior to completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01332266	COMPLETED	Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck	Eisai Inc.	2011-09-19	PHASE1; PHASE2
NCT01271504	COMPLETED	Hepatocellular Carcinoma	Eisai Inc.	2011-07-19	PHASE1; PHASE2
NCT01433991	TERMINATED	Advanced Solid Tumors	Eisai Inc.	2011-10-13	PHASE1; PHASE2
NCT01355302	TERMINATED	Advanced or Metastatic Solid Tumors; Previously Untreated Gastric Cancer	Eisai Inc.	2011-11	PHASE1; PHASE2
NCT01428141	COMPLETED	Solid Tumor; Gastric Cancer	Eisai Co., Ltd.	2011-09	PHASE1
NCT00869895	COMPLETED	Cancer	Eisai Inc.	2009-03	PHASE1
NCT01355302	Terminated	Advanced or Metastatic Solid Tumors\|Previously Untreated Gastric Cancer	Eisai Inc.\|Quintiles Inc.	2011-11	Phase 1\|Phase 2
NCT01433991	Terminated	Advanced Solid Tumors	Eisai Inc.	2011-10-13	Phase 1\|Phase 2
NCT01332266	Completed	Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck	Eisai Inc.\|PharmaBio Development Inc.	2011-09-19	Phase 1\|Phase 2
NCT01271504	Completed	Hepatocellular Carcinoma	Eisai Inc.\|PharmaBio Development Inc.	2011-07-19	Phase 1\|Phase 2
NCT00921869	COMPLETED	Solid Tumors	Eisai Co., Ltd.	2009-10	PHASE1
NCT02533102	COMPLETED	Healthy Subjects	Eisai Limited	2010-11	PHASE1
NCT02533102	Completed	Healthy Subjects	Eisai Limited\|Eisai Inc.	2010-11	Phase 1
NCT00921869	Completed	Solid Tumors	Eisai Co. Ltd.\|Eisai Inc.	2009-10	Phase 1

(data from https://clinicaltrials.gov, updated on 2022-01-03)

Check the Golvatinib (E7050) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Golvatinib (E7050) is a dual kinase inhibitor that potently targets c-Met and VEGFR-2 with IC50 values of 14 nM and 16 nM, respectively, thereby blocking downstream receptor autophosphorylation and key biochemical signaling cascades. By suppressing both c-Met-mediated tumor cell survival and VEGFR-2-driven angiogenesis, Golvatinib inhibits vascularization and tumor growth, offering therapeutic potential in clinical conditions such as advanced solid tumors, hepatocellular carcinoma, and gastric 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>).