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
18 Years
N/A
Both
Multiple Myeloma
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 University | Portland, Oregon 97239 |
