Study of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma
- Registration Number
- NCT01199718
- Lead Sponsor
- Cylene Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 22
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CX-4945 CX-4945 CX-4945 oral formulation
- Primary Outcome Measures
Name Time Method Safety One year (assessed at Cycle 1). Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Oregon Health Science University
🇺🇸Portland, Oregon, United States