SU14813 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Pfizer has sponsored multiple completed clinical trials evaluating the therapeutic potential and safety of SU14813 in oncology. These investigations include a Phase I dose-escalation clinical trial in patients with refractory solid tumors and a Phase II clinical trial assessing efficacy and safety in metastatic breast cancer. Overall, the clinical landscape for SU14813 reflects early-to-mid-phase development targeting solid malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00322517	Completed	Breast Neoplasms	Pfizer	2006-04	Phase 2
NCT00982267	Completed	Neoplasms\|Solid Tumors	Pfizer	2003-12	Phase 1

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

Check the SU14813 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SU14813 functions as a potent multi-targeted receptor tyrosine kinase inhibitor that selectively targets VEGFR1, VEGFR2, PDGFRβ, and c-Kit, thereby blocking downstream pro-survival and angiogenic biochemical signaling pathways to suppress endothelial cell proliferation and tumor vascularization. This combined antiangiogenic and direct antitumor activity provides the mechanistic rationale for evaluating SU14813 in clinical trials for the treatment of advanced solid tumors 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>).