Epothilone A Clinical Trials

Size	Price	Qty
2mg	USD 270

Clinical Trials

Several Phase 2 clinical trials, sponsored by academic and industrial entities including Bristol-Myers Squibb, Memorial Sloan Kettering Cancer Center, R-Pharm, and the University of Alabama at Birmingham, have evaluated epothilone analogs across multiple oncologic indications. Completed studies investigated these derivatives in patients with advanced esophageal and gastric adenocarcinomas, as well as platinum-pretreated non-small-cell lung cancer. Furthermore, a trial evaluating refractory metastatic colorectal cancer was ultimately terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00033306	TERMINATED	Colorectal Cancer	University of Alabama at Birmingham	2002-02	PHASE2
NCT00035516	COMPLETED	Carcinoma, Non-small-cell Lung	R-Pharm	2001-02	PHASE2
NCT00017043	COMPLETED	Esophageal Cancer; Gastric Cancer	Bristol-Myers Squibb	2001-02	PHASE2
NCT00017056	COMPLETED	Esophageal Cancer; Gastric Cancer	Memorial Sloan Kettering Cancer Center	2001-02	PHASE2

(data from https://clinicaltrials.gov, updated on 2013-08-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Epothilone A competitively binds to tubulin to promote polymerization and block normal cytoskeletal dynamics, thereby preventing mitotic spindle assembly and arresting cancer cell division. This inhibition of mitosis induces apoptotic cell death, providing the biological basis for its therapeutic investigation in solid tumors such as gastric, esophageal, non-small-cell lung, and colorectal cancers.

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>).