AEE788 (NVP-AEE788) Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

Several completed Phase 1 and Phase 1/2 clinical trials sponsored by Novartis Pharmaceuticals evaluated the safety, dosage, and efficacy of oral AEE788 in patients with advanced cancer and central nervous system tumors. These studies investigated intermittent dosing schedules of AEE788 as monotherapy and in combination with the mTOR inhibitor RAD001.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00107237	Completed	Brain and Central Nervous System Tumors	Novartis Pharmaceuticals\|Novartis	2003-10	Phase 1\|Phase 2
NCT00118456	Completed	Cancer	Novartis Pharmaceuticals\|Novartis	2003-07	Phase 1

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

Check the AEE788 (NVP-AEE788) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AEE788 functions as a multitargeted receptor tyrosine kinase inhibitor that binds to EGFR, ErbB2, and VEGFR family receptors, blocking intracellular autophosphorylation and downstream biochemical signaling to inhibit tumor cell proliferation and vascular endothelial growth. This combined anti-proliferative and anti-angiogenic activity provides the biological rationale for its clinical investigation in treating advanced solid cancers as well as brain and central nervous system tumors.

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>).