Clinical Trials

A clinical trial sponsored by Pfizer evaluated the small-molecule cyclin-dependent kinase inhibitor PF-06873600 (Ebvaciclib) in a combined Phase 1 and Phase 2 design. The study assessed the drug's safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with HR-positive/HER2-negative metastatic breast, triple-negative breast, male breast, ovarian, fallopian tube, or primary peritoneal cancer. According to current database records, recruitment for this study has been terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03519178 TERMINATED
HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer
Pfizer
 2018-03-07 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2025-11-14)

Check the PF-06873600 (Ebvaciclib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-06873600 potently binds and inhibits cyclin-dependent kinases 2, 4, and 6 (CDK2/4/6), which blocks downstream phosphorylation of the retinoblastoma protein (RB1) and halts cell cycle progression to suppress cancer cell proliferation. This inhibition of key cell cycle regulators underlies its therapeutic evaluation for suppressing tumor growth in clinical conditions such as metastatic breast cancer and ovarian malignancies.

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.