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

June 13, 2011 updated by: Cylene Pharmaceuticals

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health Science University
        • Contact:
      • Springfield, Oregon, United States, 97477
    • South Carolina
      • Greenville, South Carolina, United States, 29605
    • Virginia
    • Washington
      • Yakima, Washington, United States, 98902

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year - assessed throughout all cycles of participation
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.
One year (assessed after each cycle)
Establish the recommended Phase 2 dose
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cylene Pharmaceuticals

Investigators

  • Study Director: Study Director, Cylene Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

September 9, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 13, 2010

Study Record Updates

Last Update Posted (Estimate)

June 15, 2011

Last Update Submitted That Met QC Criteria

June 13, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4-09-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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