MLN8054 Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Several clinical trials sponsored by Millennium Pharmaceuticals, Inc. evaluated the safety, tolerability, and dosing of MLN8054 exclusively within Phase 1 development. These studies, which encompassed dose-escalation protocols and extended dosing regimens, focused on patients with advanced malignancies, including breast, colon, pancreatic, and bladder neoplasms. Across these clinical trials, recruitment has been terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00652158	TERMINATED	Advanced Malignancies	Millennium Pharmaceuticals, Inc.	2006-04	PHASE1
NCT00249301	TERMINATED	Breast Neoplasm; Colon Neoplasm; Pancreatic Neoplasm; Bladder Neoplasm	Millennium Pharmaceuticals, Inc.	2005-10	PHASE1
NCT00652158	Terminated	Advanced Malignancies	Millennium Pharmaceuticals Inc.	2006-04	Phase 1
NCT00249301	Terminated	Breast Neoplasm\|Colon Neoplasm\|Pancreatic Neoplasm\|Bladder Neoplasm	Millennium Pharmaceuticals Inc.	2005-10	Phase 1

(data from https://clinicaltrials.gov, updated on 2013-09-23)

Check the MLN8054 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MLN8054 selectively binds to and inhibits Aurora A kinase, disrupting mitotic spindle assembly and prompting G2/M phase cell cycle arrest in dividing cells. This inhibition of mitotic progression halts cellular proliferation and suppresses tumor xenograft growth, providing the therapeutic rationale for its clinical evaluation in advanced malignancies including breast, colon, pancreatic, and bladder 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>).