Riviciclib hydrochloride (P276-00) Clinical Trials

Size	Price	Qty
5mg	USD 270

Clinical Trials

Multiple clinical trials, primarily sponsored by Piramal Enterprises Limited, have evaluated Riviciclib hydrochloride (P276-00) across Phase 1, Phase 1/2, and Phase 2 stages. These studies assessed the drug alone or in combination with radiotherapy or gemcitabine for various oncological conditions, including squamous cell carcinoma of the head and neck, pancreatic cancer, mantle cell lymphoma, melanoma, breast cancer, and relapsed or refractory multiple myeloma. While several trials achieved completed recruitment status, others were terminated or withdrawn prior to full completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01903018	COMPLETED	Radiation Induced Mucositis in Head and Neck Cancer	Piramal Enterprises Limited	2012-07	PHASE2
NCT01333137	TERMINATED	Breast Cancer	Piramal Enterprises Limited	2011-08	PHASE1
NCT00835419	COMPLETED	Melanoma	Piramal Enterprises Limited	2009-05	PHASE2
NCT00824343	COMPLETED	Squamous Cell Carcinoma of Head and Neck	Piramal Enterprises Limited	2008-09	PHASE2
NCT00843050	TERMINATED	Mantle Cell Lymphoma	Piramal Enterprises Limited	2009-11	PHASE2
NCT00899054	COMPLETED	Squamous Cell Carcinoma of Head and Neck	Piramal Enterprises Limited	2009-08	PHASE1; PHASE2
NCT00898287	COMPLETED	Pancreatic Cancer	Piramal Enterprises Limited	2009-05	PHASE1; PHASE2
NCT00547404	WITHDRAWN	Multiple Myeloma	Piramal Enterprises Limited	2008-12	PHASE1
NCT00882063	COMPLETED	Relapsed and/or Refractory Multiple Myeloma	Piramal Enterprises Limited	2008-01	PHASE1; PHASE2
NCT00899054	Completed	Squamous Cell Carcinoma of Head and Neck	Piramal Enterprises Limited	2009-08	Phase 1\|Phase 2
NCT00898287	Completed	Pancreatic Cancer	Piramal Enterprises Limited	2009-05	Phase 1\|Phase 2
NCT00547404	Withdrawn	Multiple Myeloma	Piramal Enterprises Limited	2008-12	Phase 1
NCT00408018	TERMINATED	Neoplasm	Piramal Enterprises Limited	2006-03	PHASE1
NCT00407498	COMPLETED	Neoplasm	Piramal Enterprises Limited	2005-05	PHASE1
NCT00882063	Completed	Relapsed and/or Refractory Multiple Myeloma	Piramal Enterprises Limited	2008-01	Phase 1\|Phase 2
NCT00407498	Completed	Neoplasm	Piramal Enterprises Limited	2005-05	Phase 1

(data from https://clinicaltrials.gov, updated on 2014-09-04)

Check the Riviciclib hydrochloride (P276-00) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Riviciclib hydrochloride potently inhibits cyclin-dependent kinases CDK1, CDK4, and CDK9 with IC50 values of 79 nM, 63 nM, and 20 nM, respectively, thereby disrupting cell cycle progression and transcriptional elongation in neoplastic cells. Suppression of these kinase pathways induces programmed cell death, providing the biological foundation for its clinical evaluation in advanced malignancies such as pancreatic cancer, mantle cell lymphoma, and relapsed multiple myeloma.

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>).