Valrubicin Clinical Trials

Size	Price	Qty
5mg	USD 159

Clinical Trials

Valrubicin has been evaluated in several clinical trials primarily targeting urological malignancies, including bladder cancer, carcinoma in situ, non-muscle invasive bladder cancer, transitional cell carcinoma, and urothelial carcinoma. Spanning Phase 1 through Phase 3 investigations with completed, terminated, or unknown recruitment statuses, these studies have focused on intravesical administration in patients refractory to or relapsed after prior therapy. Trial sponsors encompass pharmaceutical entities alongside academic institutions and cooperative oncology networks.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01606345	COMPLETED	Urothelial Carcinoma	H. Lee Moffitt Cancer Center and Research Institute	2012-07	PHASE1
NCT01310803	TERMINATED	Carcinoma in Situ; Transitional Cell Carcinoma; Non-muscle Invasive Bladder Cancer	Endo USA Inc., a Keenova Therapeutics Company	2011-05	PHASE3
NCT00003129	COMPLETED	Bladder Cancer	Eastern Cooperative Oncology Group	1998-09-01	PHASE2
NCT01316874	COMPLETED	Carcinoma in Situ; Bladder Cancer	Endo USA Inc., a Keenova Therapeutics Company	1993-11	PHASE2; PHASE3
NCT01316874	Completed	Carcinoma in Situ\|Bladder Cancer	Endo Pharmaceuticals	1993-11	Phase 2\|Phase 3
NCT00003725	UNKNOWN	Bladder Cancer	Anthra Pharmaceuticals	1996-12	PHASE3
NCT00003759	COMPLETED	Bladder Cancer	Anthra Pharmaceuticals	1998-11	PHASE2

(data from https://clinicaltrials.gov, updated on 2016-04-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Valrubicin acts as a chemotherapy agent that inhibits TPA- and PDBu-induced protein kinase C activation with IC50 values of 0.85 μM and 1.25 μM, respectively, thereby disrupting downstream intracellular signaling pathways essential for cellular proliferation. This inhibition leads to cytotoxicity and impaired tumor cell survival, which underlies its clinical efficacy in treating carcinoma in situ and non-muscle invasive bladder cancer.

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>).