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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CX-4945 | Experimental | CX-4945 oral formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CX-4945 | Drug | CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose. | One year (assessed at Cycle 1). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Cylene Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recruiting | Kettering | Ohio | 45249 | United States |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D010954 | Plasmacytoma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C555142 | silmitasertib |
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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 |
| Oregon Health Science University | Recruiting | Portland | Oregon | 97239 | United States |
|
| Recruiting | Springfield | Oregon | 97477 | United States |
|
| Recruiting | Greenville | South Carolina | 29605 | United States |
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| Recruiting | Norfolk | Virginia | 23502 | United States |
|
| Recruiting | Yakima | Washington | 98902 | United States |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |