TAK-960 Clinical Trials

Size	Price	Qty
5mg	USD 270

Clinical Trials

Multiple clinical trials sponsored by Millennium Pharmaceuticals, Inc. have conducted Phase 1 evaluations of orally administered TAK-960 in patients with advanced nonhematological malignancies. These studies were designed to assess the drug's safety, tolerability, and pharmacokinetics in advanced solid tumors. However, recruitment across the studies was terminated prior to completion, leaving available clinical data limited to early-phase investigations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01179399	TERMINATED	Advanced Nonhematological Malignancies	Millennium Pharmaceuticals, Inc.	2010-09	PHASE1
NCT01179399	Terminated	Advanced Nonhematological Malignancies	Millennium Pharmaceuticals Inc.	2010-09	Phase 1

(data from https://clinicaltrials.gov, updated on 2014-03-03)

Check the TAK-960 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TAK-960 selectively binds to and inhibits polo-like kinase 1 (PLK1), blocking downstream phosphorylation of key mitotic substrates such as histone H3 and inducing G2/M phase cell cycle arrest with aberrant monopolar mitotic morphology. This disruption of mitotic spindle dynamics inhibits cellular proliferation and triggers apoptotic cell death, providing the biochemical basis for its clinical investigation in advanced nonhematological malignancies.

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>).