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A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients With Relapsed or Refractory Multiple Myeloma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients With Relapsed or Refractory Multiple Myeloma


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Description:

Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.

Outcome Time Frame:

One year (assessed at Cycle 1).

Safety Issue:

Yes

Principal Investigator

Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Cylene Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

C4-09-001

NCT ID:

NCT01199718

Start Date:

September 2010

Completion Date:

September 2011

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • Plasmacytoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Cleveland, Ohio  44195
Seattle, Washington  98195
McLean, Virginia  22101
Eugene, Oregon  
Charleston, South Carolina  
Oregon Health Science UniversityPortland, Oregon  97239