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

NCT ID: NCT01317927

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-06-30

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.

Conditions

Solid Tumor; Hematological Malignancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Belinostat, Warfarin

Intervention Type: DRUG

1000 mg/m2 injection infusion given in a 30 min period plus Warfarin 5mg PO

Interventions

Belinostat, Warfarin

1000 mg/m2 injection infusion given in a 30 min period plus Warfarin 5mg PO

Intervention Type: DRUG

Other Intervention Names

PXD101

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valerio Therapeutics

INDUSTRY

Sponsor Role: collaborator

Spectrum Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunil Sharma, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope, UT 84112

Locations

Huntsman Cancer Center, University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

PXD101-CLN-20

Identifier Type: -

Identifier Source: org_study_id