A Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies
Completed · Phase 1
Conditions studied: Solid Tumor, Hematological Malignancy
In brief
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.
Key facts
- Study ID
- NCT01317927
- Run by
- Spectrum Pharmaceuticals, Inc
- People needed
- 27
- Starts
- 2010-12-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2015-09-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Huntsman Cancer Center, University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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