CH5132799 Clinical Trials

Size	Price	Qty
5mg	USD 210
1g	USD 4,990

Clinical Trials

Several completed Phase 1 clinical trials, sponsored by Chugai Pharma Europe Ltd., evaluated the therapeutic potential of oral CH5132799 monotherapy in patients with solid tumors. These open-label, multi-center, dose-escalation studies aimed to assess the safety, pharmacokinetics, tolerability, and preliminary anti-tumor activity of the compound. Overall, these investigations provide essential early-phase clinical data establishing the pharmacological profile of CH5132799 in oncology.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01222546	COMPLETED	Solid Tumors	Chugai Pharma Europe Ltd.	2010-08	PHASE1
NCT01222546	Completed	Solid Tumors	Chugai Pharma Europe Ltd.	2010-08	Phase 1

(data from https://clinicaltrials.gov, updated on 2014-06-23)

Check the CH5132799 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CH5132799 selectively binds to and inhibits class I phosphoinositide 3-kinases (PI3Ks), particularly PI3Kα, thereby suppressing downstream Akt/mTOR survival signaling pathways and halting cancer cell proliferation. This targeted blockade induces potent antiproliferative activity and tumor regression, supporting its clinical evaluation for patients with solid tumors harboring PIK3CA mutations.

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>).