Bafetinib (INNO-406) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Several completed Phase 1 and Phase 2 clinical trials, sponsored by CytRx and City of Hope Medical Center, evaluated Bafetinib across various oncologic indications. Early-phase research assessed the drug's safety and pharmacokinetics in chronic myeloid leukemia and acute lymphocytic leukemia. Subsequent trials investigated Bafetinib in solid tumors and hematologic malignancies, including recurrent brain tumors such as glioblastoma, hormone-refractory prostate cancer, and B-cell chronic lymphocytic leukemia.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01234740	COMPLETED	Adult Anaplastic Astrocytoma; Adult Anaplastic Ependymoma; Adult Anaplastic Oligodendroglioma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Mixed Glioma; Recurrent Adult Brain Tumor; Tumors Metastatic to Brain; Adult Anaplastic Oligoastrocytoma	City of Hope Medical Center	2010-12	PHASE1
NCT01144260	COMPLETED	B-Cell Chronic Lymphocytic Leukemia	CytRx	2010-06	PHASE2
NCT01215799	COMPLETED	Hormone Refractory Prostate Cancer	CytRx	2010-08	PHASE2
NCT00352677	Completed	Chronic Myeloid Leukemia\|Acute Lymphocytic Leukemia	CytRx	2006-07	Phase 1

(data from https://clinicaltrials.gov, updated on 2018-04-17)

Check the Bafetinib (INNO-406) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bafetinib selectively binds to and inhibits the tyrosine kinase activity of Bcr-Abl and Lyn, thereby blocking downstream oncogenic signaling cascades essential for cellular survival. This suppression halts proliferation and triggers apoptosis in target cells, establishing a biological rationale for investigating Bafetinib in clinical trials for Bcr-Abl-driven leukemias, B-cell chronic lymphocytic leukemia, glioblastoma, and hormone-refractory prostate 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>).