BI 2536 Clinical Trials

Size	Price	Qty
5mg	USD 147
50mg	USD 670

Clinical Trials

Numerous Phase 1 and Phase 2 clinical trials, primarily sponsored by Boehringer Ingelheim and the European Organisation for Research and Treatment of Cancer (EORTC), have evaluated BI 2536 as both monotherapy and combination therapy. The clinical program investigated various oncological conditions—including non-small-cell lung carcinoma, acute myeloid leukemia, pancreatic and prostatic neoplasms, and other solid and hematologic malignancies—with study statuses recorded as either completed or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00701766	COMPLETED	Leukemia, Myeloid, Acute	Boehringer Ingelheim	2006-10	PHASE2
NCT02211833	COMPLETED	Carcinoma, Non-Small-Cell Lung	Boehringer Ingelheim	2006-10	PHASE1
NCT02215044	TERMINATED	Pancreatic Neoplasms	Boehringer Ingelheim	2007-06	PHASE1
NCT00710710	COMPLETED	Pancreatic Neoplasms	Boehringer Ingelheim	2006-08-01	PHASE2
NCT00526149	COMPLETED	Breast Cancer; Endometrial Cancer; Head and Neck Cancer; Melanoma (Skin); Ovarian Cancer; Sarcoma	European Organisation for Research and Treatment of Cancer - EORTC	2007-07	PHASE2
NCT00243087	COMPLETED	Lymphoma	Boehringer Ingelheim	2005-07	PHASE1
NCT00412880	COMPLETED	Carcinoma, Small Cell	Boehringer Ingelheim	2007-02-14	PHASE2
NCT00376623	COMPLETED	Carcinoma, Non-Small-Cell Lung	Boehringer Ingelheim	2006-07-25	PHASE2
NCT00706498	COMPLETED	Prostatic Neoplasms	Boehringer Ingelheim	2006-09	PHASE2
NCT02211859	COMPLETED	Neoplasms	Boehringer Ingelheim	2004-08	PHASE1
NCT02215044	Terminated	Pancreatic Neoplasms	Boehringer Ingelheim	2007-06	Phase 1
NCT02211872	COMPLETED	Neoplasms	Boehringer Ingelheim	2004-08	PHASE1
NCT02211833	Completed	Carcinoma Non-Small-Cell Lung	Boehringer Ingelheim	2006-10	Phase 1
NCT00701766	Completed	Leukemia Myeloid Acute	Boehringer Ingelheim	2006-10	Phase 2
NCT00706498	Completed	Prostatic Neoplasms	Boehringer Ingelheim	2006-09	Phase 2
NCT00376623	Completed	Carcinoma Non-Small-Cell Lung	Boehringer Ingelheim	2006-07-25	Phase 2
NCT02211872	Completed	Neoplasms	Boehringer Ingelheim	2004-08	Phase 1

(data from https://clinicaltrials.gov, updated on 2014-05-16)

Check the BI 2536 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BI 2536 potently binds to and inhibits Polo-like kinase 1 (Plk1), thereby disrupting critical regulators of mitosis and cytokinesis. This targeted blockade induces severe mitotic arrest and triggers apoptotic cell death, underlying its antitumor efficacy against clinical trial conditions such as non-small-cell lung carcinoma, acute myeloid leukemia, 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>).