Pyroxamide (NSC 696085) Clinical Trials

Size	Price	Qty
10mg	USD 380

Clinical Trials

A Phase 1 clinical trial sponsored by the Memorial Sloan Kettering Cancer Center evaluated Pyroxamide (NSC 696085) to assess its clinical and pharmacological profile in patients with advanced malignancies. The study encompassed a broad spectrum of oncological conditions, including leukemia, lymphoma, myelodysplastic syndromes, multiple myeloma, and solid tumors. This early-phase evaluation has completed recruitment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00042900	COMPLETED	Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Precancerous Condition; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific	Memorial Sloan Kettering Cancer Center	2002-04	PHASE1

(data from https://clinicaltrials.gov, updated on 2013-06-05)

Check the Pyroxamide (NSC 696085) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pyroxamide (NSC 696085) potently binds to and inhibits histone deacetylase 1 (HDAC1), preventing core histone deacetylation and triggering hyperacetylation within chromatin. This epigenetic modulation increases p21/WAF1 expression to induce cell cycle arrest and cell death, ultimately suppressing tumor growth in clinical contexts such as hematologic malignancies and advanced solid tumors.

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>).