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Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma

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.
 
ClinicalTrials.gov Identifier: NCT00131261
Recruitment Status : Completed
First Posted : August 18, 2005
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Onxeo

Tracking Information
First Submitted Date  ICMJE August 17, 2005
First Posted Date  ICMJE August 18, 2005
Last Update Posted Date July 8, 2015
Study Start Date  ICMJE January 2005
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma
Official Title  ICMJE A Phase II Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma
Brief Summary The purpose of this open-label, non-randomized trial is to assess the safety and effectiveness of PXD101, both alone and in combination with dexamethasone, in patients with advanced multiple myeloma. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Various members of this class of drugs have shown activity in preclinical studies and in initial clinical trials of multiple myeloma and lymphoma. Furthermore, HDAC inhibitors, including PXD101, have been shown to sensitize myeloma cells to the killing effect of other chemotherapeutic agents, including dexamethasone, a well-established agent in relapsing myeloma.
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
  • Drug: Dexamethasone
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 Completed
Actual Enrollment  ICMJE
 (submitted: March¬†31,¬†2009)
25
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  1. Signed informed consent
  2. A confirmed diagnosis of multiple myeloma, diagnostic criteria as follows, in patients who have failed at least two prior lines of therapy.

    Diagnostic criteria for multiple myeloma:

    A Monoclonal immunoglobulin (M-component) in serum of IgG-type > 30 g/l, of IgA type > 20 g/l, of IgD type or IgE type of any concentration and/or excretion of M-component in the urine of type k or l type > 1 g/24 hours.

    B M-component in serum and/or urine in lower concentration than indicated above in 'A'.

    C 10% or more plasma cells in bone marrow aspirate or plasmocytosis in biopsy from bone marrow or soft tissue tumor D Osteolytical bone lesions.

    The diagnosis of multiple myeloma demands one of the following combinations: A+C, A+D, or B+C+D.

  3. Evaluable disease (as defined above)
  4. Adequate bone marrow and hepatic functions including the following:

    1. WBC > 2.5 x 109/l, absolute neutrophil count ≥ 1.5 x 109/l, platelets ≥ 50x109/l
    2. Total bilirubin ≤1.5 x upper normal limit.
    3. AST (SGOT), ALT (SGPT) ≤2.5 x upper normal limit
  5. Serum potassium within normal range.
  6. Age ≥18 years
  7. Performance status (PS) ≤2 (ECOG scale)
  8. Estimated life expectancy greater than 3 months
  9. Female patients with reproductive potential with a negative serum pregnancy test within the last 7 days before trial enrollment and use a safe contraceptive during and in a period of 60 days after the trial. Fertile female partners to male participants must likewise use contraceptive.

Exclusion criteria

  1. Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last 4 weeks or a longer period depending on the defined characteristics of the agents used (e.g. 6 weeks for mitomycin or nitrosourea). Exception: bisphosphonates for bone disease caused by multiple myeloma.
  2. Active infection or any medical condition likely to interfere with trial procedures.
  3. Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
  4. A marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval >500; Long QT Syndrome; the required use of concomitant medication on PXD101 infusion days that may cause Torsade de Pointes. (See Appendix B for list).
  5. Patients with renal insufficiency defined as a calculated creatinine clearance of < 45 ml/min.
  6. Clinically significant central nervous system disorders requiring neuroleptics or anti-convulsant medication.
  7. Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
  8. Other malignant diseases requiring treatment
  9. Non-secretory multiple myeloma or symptomatic amyloidosis
  10. Pregnant or breast-feeding women
  11. Women of childbearing age and potential, who do not use effective contraception
  12. Known HIV positivity
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 Denmark,   Norway,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00131261
Other Study ID Numbers  ICMJE PXD101-301-G
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
Study Chair: enquiries@topotarget.com Onxeo
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