NCT00891280

Dose-escalation Study of Oral CX-4945

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Cylene Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability and highest safe dose level of this CK2 inhibitor in patients with advanced solid tumor cancers, Castleman's Disease or Multiple Myeloma.

Detailed description

Elevated CK2 activity has been associated with malignant transformation and aggressive tumor growth and overexpression of CK2 has been documented in multiple types of cancer. CK2 has emerged as a potential anticancer target and inhibition of CK2 represents a potential therapeutic strategy to target a specific molecular defect perpetuating many cancers. CX-4945 has demonstrated potent inhibition of CK2 enzymatic activity. This study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamic (PD) effects of CX-4945 administered to patients with malignancies or lymphoproliferative disorders known to overexpress CK2 including advanced solid tumors, Multiple Myeloma and Castleman's Disease.

Conditions

• Advanced Solid Tumors
• Breast Cancer
• Inflammatory Breast Cancer
• Castleman's Disease
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	CX-4945 oral formulation	CX-4945 Capsules, Oral, Dose escalation study, Dose schedule: twice daily or four times daily for 21 consecutive days every 28 days.

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-05-01
• Last updated: 2011-06-15

Locations

4 sites across 1 country: United States