Rucaparib Camsylate Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

The clinical trial landscape for Rucaparib Camsylate includes a clinical trial evaluating the safety, pharmacokinetic, and pharmacodynamic profiles of this poly(ADP-ribose) polymerase inhibitor. Sponsored by pharmaand GmbH, this completed Phase 1 study investigated intravenous administration in patients presenting with advanced solid tumors. Overall, the recorded clinical data established initial parameter baselines, reflecting early-phase industrial development targeting advanced neoplastic diseases.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01009190	Completed	Advanced Solid Tumors	pharmaand GmbH	2010-02	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rucaparib Camsylate potently binds to poly(ADP-ribose) polymerase 1 (PARP1) with a Ki of 1.4 nM, inhibiting catalytic poly(ADP-ribosyl)ation and trapping the enzyme onto damaged DNA sites. This enzymatic blockade impairs base excision repair pathways and leads to the accumulation of cytotoxic double-strand DNA breaks, thereby inducing synthetic lethality and tumor regression in patients with advanced solid tumors.

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>).