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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
CX-4945 Capsules, Oral, Dose escalation study, Dose schedule: twice daily or four times daily for 21 consecutive days every 28 days.
Mayo Clinic Arizona
Scottsdale, Arizona, United States
RECRUITINGFront Range Cancer Specialists
Fort Collins, Colorado, United States
RECRUITINGFront Range Cancer Specialists
Loveland, Colorado, United States
RECRUITINGSafety (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)
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)
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U T M D Anderson Cancer Center
Houston, Texas, United States
RECRUITING