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
| City: |
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Yakima |
| State: |
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Washington |
| Zip Code: |
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98902 |
| Conditions: |
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Multiple Myeloma |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| 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.
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| NCT ID: |
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NCT01199718 |
| Primary Contact: |
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Study Director
Study Director
Cylene Pharmaceuticals
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| Backup Contact: |
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N/A |
| Location Contact: |
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Yakima, Washington 98902
United States
Jo Cook
Email: jo.cook@yvmh.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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