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
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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.
Condition or disease | Intervention/treatment | Phase |
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Solid Tumor Hematological Malignancy | Drug: Belinostat, Warfarin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
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
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Drug: Belinostat, Warfarin
1000 mg/m2 injection infusion given in a 30 min period plus Warfarin 5mg PO
Other Name: PXD101 |
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317927
United States, Utah | |
Huntsman Cancer Center, University of Utah | |
Salt Lake City, Utah, United States, 84112 |
Principal Investigator: | Sunil Sharma, MD, FACP | Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope, UT 84112 |
Responsible Party: | Spectrum Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT01317927 |
Other Study ID Numbers: |
PXD101-CLN-20 |
First Posted: | March 17, 2011 Key Record Dates |
Last Update Posted: | September 23, 2015 |
Last Verified: | September 2015 |
belionstat warfarin hematological malignancy solid tumors PK/PD study |
Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases Belinostat Warfarin |
Anticoagulants Antineoplastic Agents Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |