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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Pharmaceuticals, Inc
• Collaborator: Onxeo
• Treatments: Belinostat; Warfarin

Criteria

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