Briciclib Clinical Trials

Size	Price	Qty
2mg	USD 147

Clinical Trials

Several clinical trials sponsored by Traws Pharma, Inc. have evaluated Briciclib as a weekly intravenous treatment in patients with neoplasms and advanced solid tumors. Designed as Phase 1 dose-escalation evaluations, these studies aimed to assess the safety, pharmacokinetics, and preliminary antitumor activity of the compound. Although the recruitment status for these trials is listed as terminated, they provide important initial data regarding the clinical development landscape for Briciclib in oncology.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02168725	TERMINATED	Neoplasms; Advanced Solid Tumor	Traws Pharma, Inc.	2014-06	PHASE1
NCT02168725	Terminated	Neoplasms\|Advanced Solid Tumor	Traws Pharma Inc.	2014-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2021-06-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Briciclib selectively binds to eukaryotic translation initiation factor 4E (eIF4E), thereby inhibiting cap-dependent protein translation and downregulating crucial oncogenic factors essential for cancer cell survival. This disruption of translation initiation arrests cellular proliferation and induces apoptosis, providing a mechanistic basis for its clinical evaluation in advanced solid tumors and neoplasms.

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>).