Regorafenib Hydrochloride Clinical Trials

Size	Price	Qty
25mg	USD 99

Clinical Trials

Several completed clinical trials, primarily sponsored by Bayer, have evaluated regorafenib across Phase 1, Phase 2, and unassigned protocols. These investigations focused on advanced oncological indications, including metastatic colorectal cancer and hepatocellular carcinoma, to assess safety, therapeutic efficacy, and long-term response. Additionally, Phase 1 research characterized the compound's pharmacokinetic properties under both fasting and dietary conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03386825	Completed	Colorectal Neoplasms	Bayer	2018-01-31	--
NCT01959269	Completed	Colorectal Neoplasm	Bayer	2013-10-31	--
NCT01002378	Completed	Dietary Fats\|Pharmacokinetics	Bayer	2009-10	Phase 1
NCT01003015	Completed	Carcinoma Hepatocellular	Bayer	2009-09	Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Regorafenib Hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Regorafenib Hydrochloride functions as a multi-target kinase inhibitor that binds to VEGFR1-3, PDGFRβ, c-Kit, RET, and Raf-1, effectively suppressing receptor autophosphorylation and downstream pro-survival signaling cascades. This comprehensive kinase blockade impairs tumor angiogenesis, disrupts supportive stromal interactions, and inhibits cell proliferation, providing therapeutic efficacy against solid tumors such as colorectal neoplasms and hepatocellular carcinoma.

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>).