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



Status:Completed
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:September 2010
End Date:September 2011

Use our guide to learn which trials are right for you!

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

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.

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.
We found this trial at
6
sites
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Kettering, OH
Click here to add this to my saved trials
?
mi
from
Springfield, OR
Click here to add this to my saved trials
?
mi
from
Yakima, WA
Click here to add this to my saved trials