Study of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma
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 relapsed or refractory multiple myeloma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients With Relapsed or Refractory Multiple Myeloma|
- Safety [ Time Frame: One year (assessed at Cycle 1). ] [ Designated as safety issue: Yes ]Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.
- Pharmacokinetic and pharmacodynamic assessments. [ Time Frame: One year - assessed throughout all cycles of participation ] [ Designated as safety issue: No ]Blood levels of study drug when administered in escalating doses and modulation of biomarkers for CK2.
- Assess for efficacy response [ Time Frame: One year (assessed after each cycle) ] [ Designated as safety issue: No ]Response assessments including M-protein levels as detailed by the International Myeloma Working Group Uniform Response Criteria.
- Establish the recommended Phase 2 dose [ Time Frame: One year ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
CX-4945 oral formulation
CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days.
Elevated CK2 activity has been associated with malignant transformation and aggressive tumor growth. Over expression of CK2 has been documented in multiple types of cancers, including multiple myeloma, 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, and pharmacodynamic effects of CX-4945 when administered to patients with multiple myeloma.
|United States, Ohio|
|Kettering, Ohio, United States, 45249|
|Contact: Michelle Owens, RN firstname.lastname@example.org|
|United States, Oregon|
|Oregon Health Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Farnoush Abar, MD email@example.com|
|Springfield, Oregon, United States, 97477|
|Contact: Jeanne Schaffer, RN firstname.lastname@example.org|
|United States, South Carolina|
|Greenville, South Carolina, United States, 29605|
|Contact: Jan Kueber, RN email@example.com|
|United States, Virginia|
|Norfolk, Virginia, United States, 23502|
|Contact: Gabrielle Geho, RN Gabrielle.Geho@usoncology.com|
|United States, Washington|
|Yakima, Washington, United States, 98902|
|Contact: Jo Cook firstname.lastname@example.org|
|Study Director:||Study Director||Cylene Pharmaceuticals|