Onatasertib (CC 223) Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Celgene has sponsored several Phase I and Phase I/II clinical trials evaluating onatasertib as monotherapy and combination therapy for hematologic malignancies and advanced solid tumors, including diffuse large B-cell lymphoma, non-small cell lung cancer, glioblastoma multiforme, hepatocellular carcinoma, neuroendocrine tumors, and hormone receptor-positive breast cancer. Designed to assess safety, pharmacokinetics, and preliminary efficacy, these studies yielded completed trials in solid tumors and non-small cell lung cancer, whereas a clinical trial in diffuse large B-cell lymphoma was terminated prior to completion. Collectively, these investigations reflect efforts to establish the therapeutic potential of onatasertib in refractory cancers.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02031419	Terminated	Lymphoma Large B-Cell Diffuse	Celgene	2013-12-18	Phase 1
NCT01545947	Completed	Carcinoma Non-Small-Cell Lung\|Non-Small Cell Lung Cancer	Celgene	2012-05-01	Phase 1
NCT01177397	Completed	Multiple Myeloma\|Diffuse Large B-Cell Lymphoma\|Glioblastoma Multiforme\|Hepatocellular Carcinoma\|Non-Small Cell Lung Cancer\|Neuroendocrine Tumors of Non-Pancreatic Origin\|Hormone Receptor-Positive Breast Cancer	Celgene	2010-07-20	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Onatasertib (CC 223) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Onatasertib (CC-223) selectively binds to and inhibits the mammalian target of rapamycin (mTOR) kinase, thereby suppressing downstream mTOR-mediated signaling cascades crucial for cellular protein synthesis, growth, and metabolic regulation. This targeted enzymatic inhibition arrests tumor cell cycle progression and induces apoptosis, providing a mechanistic rationale for its clinical evaluation in mTOR-dependent malignancies such as non-small cell lung cancer, glioblastoma, and diffuse large B-cell lymphoma.

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>).