Canertinib dihydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Pfizer has sponsored several clinical trials to evaluate the therapeutic potential of Canertinib (CI-1033) in oncology. These Phase 1 and Phase 2 studies investigated both single-agent efficacy and a combination regimen with paclitaxel and carboplatin for solid tumors, specifically advanced non-small cell lung carcinoma and metastatic breast neoplasms. Across all evaluated trials, recruitment status is listed as completed.

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

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Canertinib dihydrochloride functions as a potent, irreversible inhibitor that binds to the intracellular tyrosine kinase domains of epidermal growth factor receptor (EGFR) and ErbB2, thereby blocking cellular receptor autophosphorylation and suppressing downstream oncogenic signaling cascades. By inhibiting these crucial survival and proliferation pathways, the compound induces cell cycle arrest and apoptosis in receptor-driven malignant cells, providing a clear biological rationale for its clinical evaluation in advanced non-small cell lung carcinoma and metastatic breast neoplasms.

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>).