Cabozantinib S-malate Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 297

Clinical Trials

Multiple clinical trials are investigating cabozantinib S-malate across solid tumors, including Ewing sarcoma, osteosarcoma, neuroendocrine tumors, and advanced renal cell carcinoma. Encompassing recruiting, active not recruiting, and completed statuses, these Phase 1 interventional protocols and non-interventional observational studies evaluate cabozantinib alone or combined with therapies such as high-dose ifosfamide or peptide receptor radionuclide therapy. Studies are sponsored by academic medical centers, research foundations, and pharmaceutical companies, including Exelixis, Ipsen, Children's Hospital of Philadelphia, and Providence Health & Services.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06156410	Recruiting	Ewing Sarcoma\|Osteosarcoma	Children''s Hospital of Philadelphia\|Children''s Hospital Colorado\|Exelixis\|Alex''s Lemonade Stand Foundation	2023-10-24	Phase 1
NCT05249114	Active not recruiting	Neuroendocrine Tumors	Providence Health & Services\|Exelixis\|Advanced Accelerator Applications SA	2022-12-28	Phase 1
NCT05444933	Completed	Advanced Renal Cell Carcinoma	Ipsen	2022-09-16	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cabozantinib S-malate potently binds to receptor tyrosine kinases including VEGFR2, c-Met, AXL, Ret, and Kit, thereby inhibiting ligand-induced receptor autophosphorylation and blocking downstream biochemical signaling cascades required for tumor angiogenesis and survival. This multi-kinase inhibition induces cancer cell apoptosis and suppresses tumor vascularization, providing the mechanistic basis for its therapeutic utility in conditions such as advanced renal cell carcinoma, neuroendocrine tumors, and refractory sarcomas.

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>).