PD-0332991 (Palbociclib) Isethionate Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Multiple clinical trials evaluate palbociclib across indications such as breast cancer, advanced renal cell carcinoma, pediatric central nervous system tumors, and advanced solid neoplasms. Sponsored by institutions including Pfizer, the National Cancer Institute, M.D. Anderson Cancer Center, and the Pediatric Brain Tumor Consortium, these Phase 1, Phase 1/2, bioavailability, and observational studies carry recruitment statuses ranging from actively recruiting and completed to not yet recruiting or terminated. These protocols collectively assess therapeutic outcomes, combination regimens, and myelosuppression risk factors.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04693468	RECRUITING	Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm	M.D. Anderson Cancer Center	2020-12-01	PHASE1
NCT05665361	Recruiting	Advanced Clear Cell Renal Carcinoma (Ccrcc)\|Papillary Renal Cell Carcinoma (Prcc)	National Cancer Institute (NCI)\|National Institutes of Health Clinical Center (CC)	2024-04-24	Phase 1\|Phase 2
NCT06307457	Completed	Breast Cancer	Pfizer	2024-03-11	--
NCT05709158	Not yet recruiting	Breast Cancer	Pfizer	2024-03-01	--
NCT05912933	Not yet recruiting	Breast Cancer	Pfizer	2024-03-01	--
NCT02255461	TERMINATED	Childhood Choroid Plexus Tumor; Childhood Ependymoblastoma; Childhood Grade III Meningioma; Childhood High-grade Cerebellar Astrocytoma; Childhood High-grade Cerebral Astrocytoma; Childhood Medulloepithelioma; Recurrent Childhood Anaplastic Astrocytoma; Recurrent Childhood Anaplastic Oligoastrocytoma; Recurrent Childhood Anaplastic Oligodendroglioma; Recurrent Childhood Brain Stem Glioma; Recurrent Childhood Cerebellar Astrocytoma; Recurrent Childhood Cerebral Astrocytoma; Recurrent Childhood Giant Cell Glioblastoma; Recurrent Childhood Glioblastoma; Recurrent Childhood Gliomatosis Cerebri; Recurrent Childhood Gliosarcoma; Recurrent Childhood Medulloblastoma; Recurrent Childhood Pineoblastoma; Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor	Pediatric Brain Tumor Consortium	2014-12-08	PHASE1
NCT02041273	COMPLETED	Healthy	Pfizer	2014-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-13)

Check the PD-0332991 (Palbociclib) Isethionate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Palbociclib (PD-0332991) is a highly selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6) that blocks retinoblastoma protein phosphorylation, arresting cells in the G1 phase and preventing oncogenic cell division. This cell cycle arrest halts tumor cell proliferation, providing the mechanistic rationale for its clinical application in breast cancer, renal cell carcinomas, and solid neoplasms.

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>).