CI-1040 (PD184352) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple completed Phase 2 clinical trials have evaluated the therapeutic efficacy, anti-tumor activity, and tolerability of CI-1040 in patients with advanced solid tumors. Sponsored by academic and industrial entities, including Pfizer and the University of Alabama at Birmingham, these multicenter investigations specifically targeted breast, colorectal, non-small-cell lung, and pancreatic cancers.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00033384	COMPLETED	Breast Cancer; Colorectal Cancer; Lung Cancer; Pancreatic Cancer	University of Alabama at Birmingham	2002-02	PHASE2
NCT00034827	COMPLETED	Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms	Pfizer	2002-01	PHASE2

(data from https://clinicaltrials.gov, updated on 2013-04-12)

Check the CI-1040 (PD184352) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CI-1040 acts as an ATP non-competitive inhibitor of MEK1 and MEK2, effectively blocking the phosphorylation of downstream ERK to suppress mitogen-activated protein kinase signaling. This biochemical blockade selectively induces apoptosis and halts cell proliferation, which provides the therapeutic rationale for targeting tumor growth in advanced solid malignancies such as non-small-cell lung, breast, colorectal, and pancreatic 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>).