Delanzomib Clinical Trials

Size	Price	Qty
5mg	USD 147
50mg	USD 770

Clinical Trials

Delanzomib (CEP-18770) has been evaluated in several clinical trials across Phase I and Phase I/II settings for multiple myeloma, non-Hodgkin lymphoma, and advanced solid tumors. Sponsored by pharmaceutical entities including Teva Branded Pharmaceutical Products R&D Inc., Cephalon, and Ethical Oncology Science, these studies assessed dose escalation as well as combination regimens with lenalidomide and dexamethasone. Overall recruitment statuses for the clinical program range from completed to terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01348919	Completed	Multiple Myeloma	Teva Branded Pharmaceutical Products R&D Inc.	2011-08-03	Phase 1\|Phase 2
NCT01023880	Terminated	Multiple Myeloma	Cephalon\|Teva Branded Pharmaceutical Products R&D Inc.	2010-01	Phase 1\|Phase 2
NCT00572637	Completed	Solid Tumors\|Lymphoma Non-Hodgkin	Ethical Oncology Science	2007-11	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Delanzomib selectively binds and inhibits the chymotrypsin-like subunit of the proteasome, preventing the degradation of IκB and suppressing downstream nuclear factor-κB signaling pathways to induce tumor cell apoptosis. This targeted proteasomal blockade disrupts critical survival signals in malignant cells, providing the biological basis for its therapeutic evaluation in clinical trials for multiple myeloma, solid tumors, and non-Hodgkin 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>).