TAK-901 Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

Several clinical trials sponsored by Millennium Pharmaceuticals, Inc. evaluated the investigational small-molecule agent TAK-901 across early-stage oncology studies. These Phase 1 dose-escalation studies assessed safety, tolerability, and preliminary activity in adult patients with advanced solid tumors, lymphoma, and hematologic malignancies, including acute myeloid leukemia, chronic myelogenous leukemia, and multiple myeloma. All of these trials have officially reached completed recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00807677	COMPLETED	Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Chronic Lymphocytic Leukemia; Multiple Myeloma; Waldenstrom's Macroglobulinemia; Myelodysplastic Syndrome; Philadelphia Chromosome-negative CML; Myeloid Metaplasia; Myelofibrosis; Advanced Polycythemia; Non-Hodgkins Lymphoma	Millennium Pharmaceuticals, Inc.	2009-03	PHASE1
NCT00935844	COMPLETED	Advanced Solid Tumors; Lymphoma	Millennium Pharmaceuticals, Inc.	2009-10	PHASE1
NCT00935844	Completed	Advanced Solid Tumors\|Lymphoma	Millennium Pharmaceuticals Inc.	2009-10	Phase 1
NCT00807677	Completed	Acute Myeloid Leukemia\|Acute Lymphoblastic Leukemia\|Chronic Myelogenous Leukemia\|Chronic Lymphocytic Leukemia\|Multiple Myeloma\|Waldenstrom''s Macroglobulinemia\|Myelodysplastic Syndrome\|Philadelphia Chromosome-negative CML\|Myeloid Metaplasia\|Myelofibrosis\|Advanced Polycythemia\|Non-Hodgkins Lymphoma	Millennium Pharmaceuticals Inc.	2009-03	Phase 1

(data from https://clinicaltrials.gov, updated on 2013-07-02)

Check the TAK-901 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TAK-901 selectively binds to and inhibits Aurora kinases, particularly Aurora B, thereby preventing proper mitotic spindle attachment to centromeres during mitosis and disrupting cancer cell division. By arresting cell cycle progression and suppressing tumor cell proliferation, this mechanistic action provides potential antineoplastic activity against advanced solid tumors, lymphoma, and hematologic malignancies targeted in clinical trials.

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>).