Status:
UNKNOWN
Study of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Cylene Pharmaceuticals
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01199718
Start Date
September 1 2010
End Date
September 1 2011
Last Update
June 15 2011
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Kettering, Ohio, United States, 45249
2
Oregon Health Science University
Portland, Oregon, United States, 97239
3
Springfield, Oregon, United States, 97477
4
Greenville, South Carolina, United States, 29605