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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Cylene Pharmaceuticals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cylene Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01199718
First received: September 9, 2010
Last updated: June 13, 2011
Last verified: June 2011

September 9, 2010
June 13, 2011
September 2010
June 2011   (final data collection date for primary outcome measure)
Safety [ Time Frame: One year (assessed at Cycle 1). ] [ Designated as safety issue: Yes ]
Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.
Same as current
Complete list of historical versions of study NCT01199718 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic and pharmacodynamic assessments. [ Time Frame: One year - assessed throughout all cycles of participation ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma
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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: CX-4945
CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days.
Experimental: CX-4945
CX-4945 oral formulation
Intervention: Drug: CX-4945
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
22
September 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
United States
 
NCT01199718
C4-09-001
No
Study Director, Cylene Pharmaceuticals, Inc.
Cylene Pharmaceuticals
Not Provided
Study Director: Study Director Cylene Pharmaceuticals
Cylene Pharmaceuticals
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP