PX-12 Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 377

Clinical Trials

Multiple Phase I and Phase II clinical trials sponsored by industry entities, such as Cascadian Therapeutics and Seagen, alongside institutional collaborators like the National Cancer Institute and the Translational Genomics Research Institute, have evaluated PX-12 in advanced, metastatic, and pancreatic cancers. Recruitment statuses ranged from completed to terminated; specifically, a Phase I clinical trial assessing extended continuous infusions was completed, whereas a Phase II clinical trial investigating differing dose regimens in advanced pancreatic carcinoma was terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00736372	COMPLETED	Metastatic Cancer; Advanced Cancer	Cascadian Therapeutics Inc.	2008-06	PHASE1
NCT00417287	TERMINATED	Pancreatic Neoplasms	Cascadian Therapeutics Inc.	2006-12	PHASE2
NCT00736372	Completed	Metastatic Cancer\|Advanced Cancer	Cascadian Therapeutics Inc.\|Seagen Inc.	2008-06	Phase 1
NCT00417287	Terminated	Pancreatic Neoplasms	Cascadian Therapeutics Inc.\|National Cancer Institute (NCI)\|Translational Genomics Research Institute\|Seagen Inc.	2006-12	Phase 2

(data from https://clinicaltrials.gov, updated on 2018-05-17)

Check the PX-12 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PX-12 irreversibly inhibits thioredoxin-1 (Trx-1) through thioalkylation of its Cys73 residue, thereby disrupting intracellular redox regulation, increasing reactive oxygen species, and triggering cell death pathways in tumor cells. This targeted inhibition of Trx-1-mediated survival signaling highlights the therapeutic rationale for evaluating PX-12 in suppressing tumor growth in advanced cancers 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>).