Oleandrin (PBI-05204) Clinical Trials

Size	Price	Qty
5mg	USD 439

Clinical Trials

Multiple clinical trials have evaluated PBI-05204 (Oleandrin) in oncology, focusing on early-to-mid phase evaluations for refractory solid malignancies. A completed Phase 1 open-label trial sponsored by M.D. Anderson Cancer Center investigated PBI-05204 in patients with advanced solid tumors. Furthermore, a Phase 2 open-label, adaptive trial sponsored by Phoenix Biotechnology, Inc. was designed to evaluate the safety and efficacy of the agent in Stage IV metastatic pancreatic adenocarcinoma, though its recruitment status remains unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02329717	UNKNOWN	Pancreatic Cancer	Phoenix Biotechnology, Inc	2015-04	PHASE2
NCT00554268	COMPLETED	Solid Tumors	M.D. Anderson Cancer Center	2007-10	PHASE1

(data from https://clinicaltrials.gov, updated on 2016-09-29)

Check the Oleandrin (PBI-05204) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oleandrin selectively inhibits Na+/K+-ATPase with an IC50 of 0.62 μM, disrupting intracellular ion gradients and suppressing downstream oncogenic signaling networks. This inhibition induces apoptosis and impairs cell migration, providing the biochemical basis for its clinical investigation in treating advanced solid tumors and pancreatic cancer.

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>).