Clinical Trials

A clinical trial evaluated the safety, pharmacokinetics, and pharmacodynamics of CP-724714 in patients with metastatic HER2-overexpressing breast cancer. Sponsored by an academic research institution, the Jonsson Comprehensive Cancer Center, this completed phase I investigation monitored patient outcomes to establish dosage and biological effects. Overall, recruitment is complete for this early-stage study targeting HER2-driven malignancy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00055926 COMPLETED
Breast Cancer
Jonsson Comprehensive Cancer Center
2003-01 PHASE1

(data from https://clinicaltrials.gov, updated on 2020-08-03)

Check the CP-724714 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CP-724714 selectively binds to and inhibits the intracellular tyrosine kinase domain of HER2/ErbB2, suppressing receptor autophosphorylation and downstream oncogenic signaling pathways. By blocking these intracellular signaling cascades, the compound halts tumor cell proliferation and induces apoptosis, providing therapeutic potential for targeting HER2-overexpressing breast cancer evaluated in clinical settings.

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>).

Note: Technical data last updated: Sep 1, 2026.