Cilengitide trifluoroacetate Clinical Trials

Size	Price	Qty
5mg	USD 270
50mg	USD 990

Clinical Trials

Multiple clinical trials have evaluated Cilengitide across Phase 1 and Phase 2 studies in targeted oncology. A terminated Phase 2 trial, sponsored by Martin-Luther-Universität Halle-Wittenberg in collaboration with Merck KGaA, evaluated Cilengitide with metronomic temozolomide for pediatric and adolescent patients with relapsed or refractory high-grade gliomas. Additionally, a completed Phase 1 study, sponsored by Institut Claudius Regaud and Merck KGaA, assessed continuous infusion of Cilengitide alongside radiochemotherapy in patients with locally advanced non-small cell lung cancer.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01517776	Terminated	Gliomas	Martin-Luther-Universität Halle-Wittenberg\|Merck KGaA Darmstadt Germany	2012-01	Phase 2
NCT01118676	Completed	Locally Advanced Non Small Cell Lung Cancer (NSCLC)	Institut Claudius Regaud\|Merck KGaA Darmstadt Germany	2010-03	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cilengitide functions as a potent integrin inhibitor targeting the αvβ3 and αvβ5 receptors with IC50 values of 4.1 nM and 79 nM, respectively, thereby disrupting cell-extracellular matrix adhesion and suppressing downstream signaling pathways. By blocking integrin-mediated angiogenesis and tumor cell migration, Cilengitide impairs vascularization and invasive cellular growth, providing the mechanistic rationale for its clinical investigation in malignancies such as gliomas and non-small cell lung 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>).