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

This study has been terminated.
(Terminated due to dose limiting toxicity)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00431340
First Posted: February 5, 2007
Last Update Posted: July 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Onxeo
February 2, 2007
February 5, 2007
July 8, 2015
March 2007
June 2007   (Final data collection date for primary 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.
Same as current
Complete list of historical versions of study NCT00431340 on ClinicalTrials.gov Archive Site
  • Duration of response, time to response (TTR), and time to progression (TTP).
  • Effect on biomarkers of bone metabolism. Effect on disease-related bone pain.
Same as current
Not Provided
Not Provided
 
A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
Drug: PXD101
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
June 2007
June 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00431340
PXD101-CLN-16
Not Provided
Not Provided
Not Provided
Onxeo
Onxeo
Not Provided
Not Provided
Onxeo
July 2015

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