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A Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies

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ClinicalTrials.gov Identifier: NCT01317927
Recruitment Status : Completed
First Posted : March 17, 2011
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
Onxeo
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE March 9, 2011
First Posted Date  ICMJE March 17, 2011
Last Update Posted Date September 23, 2015
Study Start Date  ICMJE December 2010
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2011)
  • Plasma concentration and pharmacodynamic effects of warfarin [ Time Frame: 34 days ]
    Samples will be analyzed for S-warfarin and R-warfarin analytes in all evaluable subjects at the end of the trial
  • Pharmacokinetic evaluation of belinostat [ Time Frame: 34 days ]
    Pharmacokinetic evaluation of belinostat 1,000 mg/m2 and metabolites in the presence of warfarin 5mg
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01317927 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2011)
  • Presence of PK analytes for all subjects. [ Time Frame: 34 days ]
    To measure the following analytes of all evaluable subjects at the end of the trial: Belinostat, belinostat glucuronide, methylated belinostat, Beliostat amide, belinostat acid and 3-ASBA.
  • Safety profile of belinostat given concomitantly with warfarin [ Time Frame: 34 days ]
    To evaluate the safety profile of belinostat given concomitantly with warfarin 5mg. Safety and tolerability assessment include adverse events (AEs), physical examination, vital signs, clinical laboratory tests, and electrocardiograms (ECGs).
  • Overall survival of patients [ Time Frame: 8 months ]
    To evaluate progress-free survival and to assess tumor measurement
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2011)
  • Presence of PK analytes for all subjects. [ Time Frame: 34 days ]
    To measure the following analytes of all evaluable subjects at the end of the trial: Belinostat, belinostat glucuronide, methylated belinostat, Beliostat amide, belinostat acid and 3-ASBA.
  • To evaluate the safety profile of belinostat given concomitantly with warfarin 5mg. Safety and tolerability assessment include adverse events (AEs), physical examination, vital signs, clinical laboratory tests, and electrocardiograms (ECGs). [ Time Frame: 34 days ]
  • To evaluate progress-free survival and to assess tumor measurement [ Time Frame: 8 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies
Official Title  ICMJE A Phase I Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies
Brief Summary

The purpose of this study is to evaluate the plasma concentration and pharmacodynamics effects of warfarin 5 mg, in the presence or absence of belinostat 1,000 mg/m².

Pharmacokinetic evaluation of belinostat 1,000 mg/m² and metabolites in the presence of warfarin 5 mg.

Detailed Description This is an open-label, single center, pharmacokinetic and pharmacodynamic study in patients with solid tumor or hematological malignancies. Upon providing informed consent and satisfying screening procedures, eligible subjects will report to the clinic for Part I of the study 14 days before the first dose of belinostat (Day -14) for clinical laboratory tests, warfarin (5mg) single dose and a series PK collections. On days 1-5 of each 21-day cycle patients will receive belinostat 1000mg/m*2 and will have a series of subsequent PK samples collected. On day 3 of cycle 1 only, the patient will also receive warfarin 5mg single dose prior to belinostat infusion. PK samples, urine samples, electrocardiogram (ECG) and safety measurements will be collected from Day 1 through Day 10 of cycle one. If it is in the interest of the patient, belinostat can be continued during Part II- extension phase for 5 additional cycles of belinostat treatment on days 1-5 of each subsequent cycle, or until disease progression, patient withdraws consent or if unacceptable toxicity occurs. During the extension phase routine physical exams, laboratory tests and safety and efficacy assessments will be performed. Disease evaluations will be conducted per standard of care. Patients who discontinue for reasons other than disease progression will be followed until new anti-cancer treatment is initiated or death.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Hematological Malignancy
Intervention  ICMJE Drug: Belinostat, Warfarin
1000 mg/m2 injection infusion given in a 30 min period plus Warfarin 5mg PO
Other Name: PXD101
Study Arms  ICMJE Experimental: Warfarin, Belinostat
Warfarin 5 mg po will be given on Day -14 and Day 3. Belinostat 1000 mg/m² will be given as a 30 minute IV infusion on Days 1 - 5
Intervention: Drug: Belinostat, Warfarin
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: September 21, 2015)
27
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2011)
24
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed consent
  • Histological or cytological confirmed diagnosis of malignant disease
  • Age ≥18 years old
  • Adequate organ function
  • ECOG 0-2
  • Estimated life expectancy >3months
  • Negative pregnancy test for women of child bearing potential

Exclusion Criteria:

  • Low dose anticoagulation therapy within 2 week prior to study treatment
  • Anticancer therapy within 2 weeks prior to study treatment
  • Investigational therapy within 4 weeks of study treatment
  • Major surgery within 2 weeks of study treatment
  • Coexisting active infection or other medical condition likely to interfere with trial procedures
  • Significant cardiovascular disease (NYHA Class III or IV)
  • Baseline prolongation of QT/QTc
  • Clinically significant CNS disorder, altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completing trial procedures
  • Symptomatic or untreated CNS metastases
  • Pregnant or breast feeding women
  • Patients not willing to use effective contraception
  • Known infection with HIV, Hep B or Hep C
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 NCT01317927
Other Study ID Numbers  ICMJE PXD101-CLN-20
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spectrum Pharmaceuticals, Inc
Study Sponsor  ICMJE Spectrum Pharmaceuticals, Inc
Collaborators  ICMJE Onxeo
Investigators  ICMJE
Principal Investigator: Sunil Sharma, MD, FACP Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope, UT 84112
PRS Account Spectrum Pharmaceuticals, Inc
Verification Date September 2015

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