Study of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Unknown status
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cylene Pharmaceuticals

Criteria

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.