Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Cylene Pharmaceuticals.
Recruitment status was:  Recruiting
Information provided by:
Cylene Pharmaceuticals Identifier:
First received: September 9, 2010
Last updated: June 13, 2011
Last verified: June 2011
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.

Condition Intervention Phase
Multiple Myeloma
Drug: CX-4945
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Cylene Pharmaceuticals:

Primary Outcome Measures:
  • Safety [ Time Frame: One year (assessed at Cycle 1). ]
    Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.

Secondary Outcome Measures:
  • Pharmacokinetic and pharmacodynamic assessments. [ Time Frame: One year - assessed throughout all cycles of participation ]
    Blood levels of study drug when administered in escalating doses and modulation of biomarkers for CK2.

  • Assess for efficacy response [ Time Frame: One year (assessed after each cycle) ]
    Response assessments including M-protein levels as detailed by the International Myeloma Working Group Uniform Response Criteria.

  • Establish the recommended Phase 2 dose [ Time Frame: One year ]

Estimated Enrollment: 22
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CX-4945
CX-4945 oral formulation
Drug: CX-4945
CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days.

Detailed 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01199718

United States, Ohio
Kettering, Ohio, United States, 45249
Contact: Michelle Owens, RN   
United States, Oregon
Oregon Health Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Farnoush Abar, MD   
Springfield, Oregon, United States, 97477
Contact: Jeanne Schaffer, RN   
United States, South Carolina
Greenville, South Carolina, United States, 29605
Contact: Jan Kueber, RN   
United States, Virginia
Norfolk, Virginia, United States, 23502
Contact: Gabrielle Geho, RN   
United States, Washington
Yakima, Washington, United States, 98902
Contact: Jo Cook   
Sponsors and Collaborators
Cylene Pharmaceuticals
Study Director: Study Director Cylene Pharmaceuticals
  More Information

Responsible Party: Study Director, Cylene Pharmaceuticals, Inc. Identifier: NCT01199718     History of Changes
Other Study ID Numbers: C4-09-001
Study First Received: September 9, 2010
Last Updated: June 13, 2011

Keywords provided by Cylene Pharmaceuticals:
Multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases processed this record on April 25, 2017