Study of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: CX-4945


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females at least 18 years of age Confirmed relapsed or refractory multiple myeloma after at least two prior lines of therapy. Measureable disease. Karnofsky Performance Status at least 60% Adequate liver and renal function and hematology laboratory values Female patients of child-bearing potential must have a negative pregnancy test. Signed informed consent. Exclusion Criteria: Treatment with systemic cancer therapy within 21 days before screening. Major surgery within 4 weeks or minor surgery within 2 weeks of the start of study drug. Grade 3 sensory neuropathy or motor neuropathy with pain Concurrent severe or uncontrolled medical disease. Active systemic fungal, bacterial, and/or viral infection. Difficulty with swallowing, or an active malabsorption syndrome. Gastrointestinal diseases including Crohn's disease or hemorrhagic coloproctitis. History of gastric or small bowel surgery. Pregnant or nursing females.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CX-4945<br>CX-4945 oral formulation | Drug: CX-4945<br>* CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose. | One year (assessed at Cycle 1). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic and pharmacodynamic assessments. | Blood levels of study drug when administered in escalating doses and modulation of biomarkers for CK2. | 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. | One year (assessed after each cycle) | 
| Establish the recommended Phase 2 dose |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple myeloma, Plasmacytoma