PX-478 Dihydrochloride Clinical Trials

Size	Price	Qty
1mg*5	USD 147
25mg	USD 477

Clinical Trials

Several completed Phase 1 clinical trials, sponsored by industry partners including Cascadian Therapeutics Inc. and Seagen Inc., have evaluated the safety and therapeutic potential of oral PX-478 Dihydrochloride. These studies investigated oral dosing protocols for this hypoxia-inducible factor inhibitor in patients diagnosed with advanced solid tumors and lymphoma. Ultimately, these early-phase evaluations provide initial clinical characterization of the agent in advanced solid malignancies and hematologic neoplasms.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00522652	COMPLETED	Advanced Solid Tumors; Lymphoma	Cascadian Therapeutics Inc.	2007-08	PHASE1
NCT00522652	Completed	Advanced Solid Tumors\|Lymphoma	Cascadian Therapeutics Inc.\|Seagen Inc.	2007-08	Phase 1

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

Check the PX-478 Dihydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PX-478 Dihydrochloride selectively inhibits hypoxia-inducible factor-1α (HIF-1α) activity, suppressing the transcriptional activation of downstream hypoxia-responsive genes crucial for tumor adaptation and survival under hypoxic microenvironments. This biochemical blockade downregulates pro-survival signal transduction and induces targeted apoptotic cell death, which provides a mechanistic rationale for its clinical investigation in patients with advanced solid tumors and lymphoma.

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>).