Canertinib (CI-1033) Clinical Trials

Size	Price	Qty
10mg	USD 147
1g	USD 1,900

Clinical Trials

Multiple clinical trials sponsored by Pfizer have evaluated Canertinib (CI-1033) across early clinical development phases for solid tumor malignancies, specifically advanced non-small cell lung cancer and metastatic breast cancer. These Phase 1 and Phase 2 investigations evaluated the drug as both single-agent monotherapy and in combination with paclitaxel and carboplatin. All documented trials have reached completed recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00050830	Completed	Lung Neoplasms	Pfizer	2003-01	Phase 2
NCT00174356	Completed	Carcinoma Non-Small Cell Lung	Pfizer	2002-12	Phase 1
NCT00051051	Completed	Breast Neoplasms	Pfizer	2002-12	Phase 2
NCT00051051	COMPLETED	Breast Neoplasms	Pfizer	2002-12	PHASE2
NCT00050830	COMPLETED	Lung Neoplasms	Pfizer	2003-01	PHASE2
NCT00174356	COMPLETED	Carcinoma, Non-Small Cell Lung	Pfizer	2002-12	PHASE1

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

Check the Canertinib (CI-1033) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Canertinib (CI-1033) is an orally bioavailable, irreversible pan-ErbB tyrosine kinase inhibitor that binds to the ATP-binding pockets of EGFR, ErbB2, ErbB3, and ErbB4, thereby blocking receptor autophosphorylation and inhibiting downstream MAPK and AKT signaling pathways. This potent cellular inhibition blocks pro-survival signaling and induces tumor cell apoptosis, underlying its clinical application in ErbB-dependent cancers such as non-small cell lung cancer and metastatic breast 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>).