Back to resultsStudy of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CX-4945
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, Plasmacytoma
Eligibility Criteria
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.
Sites / Locations
- Recruiting
- Oregon Health Science UniversityRecruiting
- Recruiting
- Recruiting
- Recruiting
- Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CX-4945
Arm Description
CX-4945 oral formulation
Outcomes
Primary Outcome Measures
Safety
Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.
Secondary Outcome Measures
Pharmacokinetic and pharmacodynamic assessments.
Blood levels of study drug when administered in escalating doses and modulation of biomarkers for CK2.
Assess for efficacy response
Response assessments including M-protein levels as detailed by the International Myeloma Working Group Uniform Response Criteria.
Establish the recommended Phase 2 dose
Full Information
NCT ID
NCT01199718
First Posted
September 9, 2010
Last Updated
June 13, 2011
Sponsor
Cylene Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01199718
Brief Title
Study of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Cylene Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple myeloma, Plasmacytoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CX-4945
Arm Type
Experimental
Arm Description
CX-4945 oral formulation
Intervention Type
Drug
Intervention Name(s)
CX-4945
Intervention Description
CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days.
Primary Outcome Measure Information:
Title
Safety
Description
Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.
Time Frame
One year (assessed at Cycle 1).
Secondary Outcome Measure Information:
Title
Pharmacokinetic and pharmacodynamic assessments.
Description
Blood levels of study drug when administered in escalating doses and modulation of biomarkers for CK2.
Time Frame
One year - assessed throughout all cycles of participation
Title
Assess for efficacy response
Description
Response assessments including M-protein levels as detailed by the International Myeloma Working Group Uniform Response Criteria.
Time Frame
One year (assessed after each cycle)
Title
Establish the recommended Phase 2 dose
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Cylene Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Owens, RN
Email
michelle.owens@khnetwork.org
Facility Name
Oregon Health Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farnoush Abar, MD
Email
abarfa@ohsu.edu
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne Schaffer, RN
Email
jeanne.schaffer@usoncology.com
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Kueber, RN
Email
jkueber@ghs.org
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabrielle Geho, RN
Email
Gabrielle.Geho@usoncology.com
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jo Cook
Email
jo.cook@yvmh.org
12. IPD Sharing Statement
Learn more about this trial
Study of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma
We'll reach out to this number within 24 hrs