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

Cylene Pharmaceuticals

Status and phase

Unknown

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: CX-4945

Study type

Interventional

Funder types

Industry

Identifiers

NCT01199718

C4-09-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.