TAK-733 Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Multiple clinical trials, primarily sponsored by Millennium Pharmaceuticals, Inc., have evaluated the investigational agent TAK-733 in patients with advanced nonhematologic malignancies and advanced metastatic melanoma. This Phase I clinical landscape encompasses completed monotherapy dose-escalation studies as well as combination evaluations with alisertib that were withdrawn prior to completion. Overall, these early-stage investigations reflect the initial clinical development profile of TAK-733 across solid tumor oncology settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01613261	WITHDRAWN	Advanced Nonhematologic Malignancies	Millennium Pharmaceuticals, Inc.	2013-08	PHASE1
NCT01613261	Withdrawn	Advanced Nonhematologic Malignancies	Millennium Pharmaceuticals Inc.	2013-08	Phase 1
NCT00948467	COMPLETED	Advanced Non-hematologic Malignancies; Advanced Metastatic Melanoma	Millennium Pharmaceuticals, Inc.	2009-12	PHASE1
NCT00948467	Completed	Advanced Non-hematologic Malignancies\|Advanced Metastatic Melanoma	Millennium Pharmaceuticals Inc.	2009-12	Phase 1

(data from https://clinicaltrials.gov, updated on 2013-11-01)

Check the TAK-733 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TAK-733 selectively binds to the allosteric site of MEK1/2, inhibiting their enzymatic activity and suppressing downstream phosphorylation of ERK effector proteins. By blocking RAS/RAF/MEK/ERK pathway signaling and impairing tumor cell proliferation, this targeted inhibition provides the biological rationale for evaluating TAK-733 in advanced nonhematologic malignancies and metastatic melanoma.

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>).