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

Status unconfirmed · Phase 1

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT01199718

Run by

Cylene Pharmaceuticals

People needed

22

Starts

2010-09-01

Expected to finish

2011-09-01

Last updated by the study team

2011-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Kettering, Ohio, United States (enrolling)
• Oregon Health Science University — Portland, Oregon, United States (enrolling)
• Study site — Springfield, Oregon, United States (enrolling)
• Study site — Greenville, South Carolina, United States (enrolling)
• Study site — Norfolk, Virginia, United States (enrolling)
• Study site — Yakima, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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