A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX- 4945 Administered Orally to Patients with Advanced Solid Tumors, Castleman’s Disease or Multiple Myeloma
A Phase I, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients with Advanced Solid Tumors, Castleman's Disease or Multiple Myeloma". This is a Phase I and Proof of Concept study of CX-4945, a novel oral inhibitor of CK2, a serine/threonine protein kinase overexpressed in lung carcinoma, breast carcinoma, prostate carcinoma, renal cell carcinoma, head and neck squamous cell carcinoma, multiple myeloma, and Castleman's disease. This protocol is available for patients with these diagnoses experiencing disease progression despite conventional treatments. Key inclusion criteria are: 1) measurable disease by RECIST criteria or evaluable disease 2) Karnofsky performance of 70% or better, and 3) expected life expectancy of at least three months. The study requires reliable intravenous access (central IV port or upper extremity PICC line) during the first 28 day cycle of treatment to facilitate pharmacokinetic and pharmacodynamic research related blood tests.
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