Clinical Trials

Multiple clinical trials spanning Phase I through Phase III evaluate the comparative bioavailability, safety, and therapeutic delivery of Cremophor EL formulations versus vehicle-free alternatives. Sponsored by major governmental, academic, and corporate entities—including the National Institutes of Health Clinical Center, Celgene Corporation, Memorial Sloan Kettering Cancer Center, Oasmia Pharmaceutical AB, and NeuroVive Pharmaceutical AB—these studies involve healthy volunteers as well as patients with adult solid tumors, non-small cell lung cancer, epithelial ovarian, primary peritoneal, fallopian tube cancers, or hemodialysis graft dysfunction. Although the majority of these investigations have been completed, select studies were prematurely terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00989131 COMPLETED
Epithelial Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer
Oasmia Pharmaceutical AB
 2009-02 PHASE3
NCT01692834 COMPLETED
Healthy
NeuroVive Pharmaceutical AB
 2009-06 PHASE1
NCT00077246 COMPLETED
Lung Cancer
Memorial Sloan Kettering Cancer Center
 2003-09 PHASE1; PHASE2
NCT00249002 TERMINATED
Hemodialysis Graft Dysfunction
Celgene
 2005-11-01 PHASE2
NCT00095914 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
National Institutes of Health Clinical Center (CC)
 2004-09 PHASE1
NCT00073723 COMPLETED
Non-Small Cell Lung Cancer
Celgene Corporation
 2003-12 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2014-02-04)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a polyethoxylated non-ionic surfactant, Cremophor EL forms amphiphilic micelles that encapsulate poorly water-soluble lipophilic molecules, thereby enhancing chemical dissolution and facilitating systemic membrane transport. This solubilization profile enables effective intravenous administration and bioavailability of hydrophobic antineoplastic agents, directly supporting therapeutic delivery in clinical trials for solid tumors, non-small cell lung cancer, and ovarian malignancies.

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.