OSI-027 Clinical Trials

Size	Price	Qty
5mg	USD 147
50mg	USD 570

Clinical Trials

Multiple completed Phase I clinical trials sponsored by Astellas Pharma Inc have evaluated the therapeutic potential of OSI-027 in patients presenting with solid tumors or lymphoma. These early-stage studies investigated various dose-escalation strategies, comparing intermittent, once-weekly, and continuous daily oral dosing regimens to characterize the drug's safety profile, tolerability, and preliminary efficacy. Together, these clinical investigations established foundational data for targeting advanced solid malignancies and hematologic cancers.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00698243	COMPLETED	Any Solid Tumor or Lymphoma	Astellas Pharma Inc	2008-06	PHASE1
NCT00698243	Completed	Any Solid Tumor or Lymphoma	Astellas Pharma Inc	2008-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2013-04-15)

Check the OSI-027 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

OSI-027 potently binds to both the raptor-mTOR (mTORC1) and rictor-mTOR (mTORC2) complexes, inhibiting downstream serine/threonine kinase signaling within the PI3K/Akt/mTOR pathway to induce autophagy and apoptosis in tumor cells. This dual enzymatic inhibition suppresses cell proliferation and primitive leukemic precursor growth, offering potential clinical utility for treating patients with advanced solid tumors or 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>).