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

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ClinicalTrials.gov Identifier: NCT00431340
Recruitment Status : Terminated (Terminated due to dose limiting toxicity)
First Posted : February 5, 2007
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Onxeo

Tracking Information
First Submitted Date  ICMJE February 2, 2007
First Posted Date  ICMJE February 5, 2007
Last Update Posted Date July 8, 2015
Study Start Date  ICMJE March 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2007)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2007)
  • Duration of response, time to response (TTR), and time to progression (TTP).
  • Effect on biomarkers of bone metabolism. Effect on disease-related bone pain.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
Official Title  ICMJE A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Drug: PXD101
Study Arms  ICMJE Not Provided
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 Terminated
Actual Enrollment  ICMJE
 (submitted: November 30, 2012)
4
Original Enrollment  ICMJE
 (submitted: February 2, 2007)
35
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00431340
Other Study ID Numbers  ICMJE PXD101-CLN-16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Onxeo
Study Sponsor  ICMJE Onxeo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Onxeo
Verification Date July 2015

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