Clinical Trial: Dose-escalation Study of Oral CX-4945

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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, Ca

Brief 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 Summary: 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.
Sponsor: Cylene Pharmaceuticals

Current Primary Outcome:

  • Safety (Dose limiting toxicities, maximum tolerated dose) [ Time Frame: One year (Assessed at Cycle 1) ]
  • Drug-related adverse events [ Time Frame: One Year (Asessed from first administration of study drug through 30 days after the last dose) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacokinetic and pharmacodynamic assessments [ Time Frame: One Year (Assessed during Cycle 1) ]
  • Observe evidence of antitumor activity [ Time Frame: One Year (Assessed after every two cycles) ]
  • Establish the recommended Phase 2 dose [ Time Frame: One Year (Study completion) ]


Original Secondary Outcome: Same as current

Information By: Cylene Pharmaceuticals

Dates:
Date Received: April 29, 2009
Date Started: February 2009
Date Completion: December 2011
Last Updated: June 13, 2011
Last Verified: June 2011