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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01199718
Recruitment Status : Unknown
Verified June 2011 by Cylene Pharmaceuticals.
Recruitment status was:  Recruiting
First Posted : September 13, 2010
Last Update Posted : June 15, 2011
Information provided by:
Cylene Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: CX-4945 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
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.

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

Secondary Outcome Measures :
  1. 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.

  2. 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.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01199718

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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
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Study Director: Study Director Cylene Pharmaceuticals

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Responsible Party: Study Director, Cylene Pharmaceuticals, Inc. Identifier: NCT01199718     History of Changes
Other Study ID Numbers: C4-09-001
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: June 2011

Keywords provided by Cylene Pharmaceuticals:
Multiple myeloma

Additional relevant MeSH terms:
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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