Multiple Myeloma
Conditions
Keywords
Multiple myeloma, Plasmacytoma
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 relapsed or refractory multiple myeloma.
Detailed description
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.
Interventions
DRUGCX-4945
CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days.
Sponsors
Cylene Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | One year (assessed at Cycle 1). | Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic and pharmacodynamic assessments. | One year - assessed throughout all cycles of participation | Blood levels of study drug when administered in escalating doses and modulation of biomarkers for CK2. |
| Assess for efficacy response | One year (assessed after each cycle) | Response assessments including M-protein levels as detailed by the International Myeloma Working Group Uniform Response Criteria. |
| Establish the recommended Phase 2 dose | One year | — |
Countries
United States
Outcome results
None listed