PF-562271 Besylate Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 817

Clinical Trials

PF-562271 Besylate has been evaluated in a clinical trial to investigate its therapeutic potential in clinical oncology. Sponsored by industry sponsor Verastem Inc., this completed Phase I open-label dose-escalation study assessed the safety, pharmacokinetics, and pharmacodynamics of the compound in patients with advanced solid malignancies, specifically focusing on head and neck, prostatic, and pancreatic neoplasms. These early-phase clinical data provide fundamental insight into the human tolerability and pharmacodynamic activity of PF-562271 across these targeted cancer indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00666926	Completed	Head and Neck Neoplasm\|Prostatic Neoplasm\|Pancreatic Neoplasm	Verastem Inc.	2005-12	Phase 1

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

Check the PF-562271 Besylate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-562271 Besylate acts as a potent, ATP-competitive inhibitor of focal adhesion kinase (FAK) and proline-rich tyrosine kinase (Pyk2), preventing integrin-mediated activation of downstream pathways including ERK, JNK/MAPK, and PI3K/Akt. Consequently, this blockade suppresses tumor cell migration, invasion, proliferation, and angiogenesis, offering targeted antineoplastic activity relevant to head and neck, prostatic, and pancreatic 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>).