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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days.
Unnamed facility
Kettering, Ohio, United States
RECRUITINGOregon Health Science University
Portland, Oregon, United States
RECRUITINGUnnamed facility
Springfield, Oregon, United States
Safety
Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.
Time frame: One year (assessed at Cycle 1).
Pharmacokinetic and pharmacodynamic assessments.
Blood levels of study drug when administered in escalating doses and modulation of biomarkers for CK2.
Time frame: One year - assessed throughout all cycles of participation
Assess for efficacy response
Response assessments including M-protein levels as detailed by the International Myeloma Working Group Uniform Response Criteria.
Time frame: One year (assessed after each cycle)
Establish the recommended Phase 2 dose
Time frame: One year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Greenville, South Carolina, United States
RECRUITINGUnnamed facility
Norfolk, Virginia, United States
RECRUITINGUnnamed facility
Yakima, Washington, United States
RECRUITING