Clinical Trials

The clinical evaluation of this compound features a clinical trial focused on assessing therapeutic safety and activity in patients with relapsed or refractory neuroblastoma. Sponsored by collaborative organizations, including the New Approaches to Neuroblastoma Therapy Consortium, SignalRX Pharmaceuticals Inc., and the University of Southern California, this Phase 1 study has been terminated, concluding its early-stage evaluation in this pediatric cancer setting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02337309 Terminated
Neuroblastoma
New Approaches to Neuroblastoma Therapy Consortium|SignalRX Pharmaceuticals Inc.|University of Southern California
2015-07-09 Phase 1

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

Check the LY294002 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY294002 acts as a competitive ATP-site inhibitor of class I phosphoinositide 3-kinases, which suppresses downstream Akt pathway signaling and halts autophagosome formation. This signal disruption inhibits cellular proliferation and induces apoptosis, thereby reducing tumor cell growth in PI3K-dependent malignancies such as neuroblastoma.

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>).

Note: Technical data last updated: Sep 1, 2026.