PF-477736 Clinical Trials

Size	Price	Qty
5mg	USD 147
50mg	USD 670

Clinical Trials

A clinical trial sponsored by Pfizer evaluated the therapeutic potential of PF-477736 in combination with gemcitabine for patients with advanced solid malignancies and neoplasms. This Phase 1 study aimed to assess safety, tolerability, and clinical profiles in advanced neoplastic conditions, but the trial was ultimately terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00437203	Terminated	Neoplasms	Pfizer	2006-12	Phase 1

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

Check the PF-477736 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-477736 functions as a potent, ATP-competitive inhibitor of checkpoint kinase 1 (Chk1) that selectively binds to the kinase active site to prevent downstream substrate phosphorylation and abrogate checkpoint control. This inhibition disrupts the cell cycle, leading to accumulated DNA damage, impaired genomic repair, and enhanced apoptotic death in target cells, demonstrating therapeutic relevance for impairing tumor growth in 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>).