JNJ-38877605 Clinical Trials

Size	Price	Qty
5mg	USD 247
50mg	USD 970

Clinical Trials

Industry sponsors, including Johnson & Johnson Pharmaceutical Research & Development and Ortho Biotech Inc., initiated multiple Phase 1 clinical trials to evaluate JNJ-38877605, a selective receptor tyrosine kinase inhibitor, in patients with advanced neoplasms. These studies aimed to assess the drug's safety, pharmacokinetics, and pharmacodynamics in oncology populations, though recruitment for these evaluations has been terminated. Overall, clinical evaluation of JNJ-38877605 remains focused on early-phase safety and pharmacological profiling in malignant conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00651365	TERMINATED	Neoplasms	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2008-02	PHASE1
NCT00651365	Terminated	Neoplasms	Johnson & Johnson Pharmaceutical Research & Development L.L.C.\|Ortho Biotech Inc.	2008-02	Phase 1

(data from https://clinicaltrials.gov, updated on 2013-03-08)

Check the JNJ-38877605 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

JNJ-38877605 functions as an ATP-competitive inhibitor of c-Met tyrosine kinase, blocking c-Met autophosphorylation and downstream oncogenic signaling pathways to suppress cellular proliferation and survival in c-Met-dependent tumor cells. By inducing xenograft regression and halting receptor-mediated signal transduction, this targeted inhibition addresses the hyperactive c-Met signaling often observed in various advanced neoplasms investigated in clinical trials.

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>).