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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2010

Last Updated Date

June 13, 2011

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01199718 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Myeloma

Intervention ^ICMJE

Drug: CX-4945

CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days.

Study Arm (s)

Experimental: CX-4945

CX-4945 oral formulation

Intervention: Drug: CX-4945

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2011

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01199718

Other Study ID Numbers ^ICMJE

C4-09-001

Has Data Monitoring Committee

Responsible Party

Study Director, Cylene Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

Cylene Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Study Director

Cylene Pharmaceuticals

Information Provided By

Cylene Pharmaceuticals

Verification Date

June 2011

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

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