A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma

July 7, 2015 updated by: Onxeo
This open-label study will assess anti-tumor activity and safety of belinostat in combination with bortezomib (Velcade®) in multiple myeloma patients refractory to or relapsed from at least one prior bortezomib-containing regimen. Subjects will be administered both PXD101 and bortezomib on the same days: i.e. days 1, 4, 8, and 11 of a 3-week cycle, for up to 8 cycles.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

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
    • California
      • West Hollywood, California, United States, 90069
        • Oncotherapeutics
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

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:

  • Diagnosis of multiple myeloma.
  • Status of refractory to or relapsed from at least one prior bortezomib-containing regimen.
  • Progressive disease.
  • Age >= 18 years.
  • Karnofsky performance status >= 60%

  • Acceptable liver function:

    • Bilirubin =< 1.5 x ULN (upper limit of normal)
    • Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3 x ULN

  • Acceptable hematologic status:

    • Absolute Neutrophil Count (ANC) >= 1.5 x 109/L
    • Platelet count >= 100 x 109/L
    • Hemoglobin >= 9 g/dL
    • Coagulation status PT-INR/PTT =< 1.5 x ULN or in the therapeutic range if on anticoagulation therapy. (PT-INR/PTT= prothrombin - international normalized ratio / prothrombin time)
    • Serum potassium within normal range.
  • Estimated life expectancy greater than 3 months.
  • Signed, written IRB (institutional Review Board)-approved informed consent.

Exclusion Criteria:

  • Non-secretory multiple myeloma or symptomatic amyloidosis.
  • Hypersensitivity to bortezomib, boron, or mannitol.
  • Less than 4 weeks since prior chemotherapy, radiotherapy, endocrine therapy, or immunotherapy, except if disease is rapidly progressing.
  • Less than 4 weeks since prior use of other investigational agents.
  • Serious concomitant systemic disorders (e.g. active infection).
  • Significant cardiovascular disease.
  • Marked baseline prolongation of QT/QTc (corrected QT interval)interval.
  • Central nervous system disorders requiring neuroleptics / anti-convulsants.
  • Peripheral sensory neuropathy of ≥ Grade 2
  • Renal insufficiency defined as a creatinine clearance of < 30 ml/min.
  • Non-willingness to use effective contraceptive methods for patients of child-bearing age / potential.
  • Pregnant or breast-feeding women.
  • Known HIV positivity.
  • Prior treatment with belinostat (PXD101), or any other HDAC (histone deacetylase) inhibitor.
  • Altered mental status which precludes an understanding of the Informed Consent Document.

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Objective response rate of belinostat administered in combination with bortezomib in multiple myeloma subjects who are refractory to or have relapsed from at least one prior bortezomib-containing regimen.
Safety of belinostat plus bortezomib.

Secondary Outcome Measures

Outcome Measure
Duration of response, time to response (TTR), and time to progression (TTP).
Effect on biomarkers of bone metabolism. Effect on disease-related bone pain.

Collaborators and Investigators

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

Sponsor

Onxeo

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

March 1, 2007

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

February 2, 2007

First Submitted That Met QC Criteria

February 2, 2007

First Posted (Estimate)

February 5, 2007

Study Record Updates

Last Update Posted (Estimate)

July 8, 2015

Last Update Submitted That Met QC Criteria

July 7, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PXD101-CLN-16

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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