Clinical Trials

The clinical evaluation of PHA-793887 in oncology comprises a clinical trial sponsored by Nerviano Medical Sciences. This Phase I dose-escalation study evaluated the safety, pharmacokinetics, and preliminary efficacy of intravenously administered PHA-793887 in patients with advanced or metastatic solid tumors. Although recruitment for the study was terminated, it focused on establishing tolerated dosage regimens and early-phase safety profiles.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00996255 TERMINATED
Advanced/Metastatic Solid Tumors
Nerviano Medical Sciences
 2006-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2009-10-16)

Check the PHA-793887 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PHA-793887 functions as a potent pan-cyclin-dependent kinase inhibitor targeting CDK1, CDK2, CDK4, CDK5, CDK7, and CDK9, thereby suppressing retinoblastoma protein phosphorylation and downregulating S-phase cyclins like cyclin A. By disrupting these crucial cell-cycle drivers, the agent induces cell-cycle arrest and apoptosis, which directly accounts for its anti-proliferative activity against advanced and metastatic solid tumors evaluated in clinical studies.

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>).

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