NCT01317927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

4.5 years

First QC Date

March 9, 2011

Last Update Submit

September 21, 2015

Conditions

Solid TumorHematological Malignancy

Keywords

belionstatwarfarinhematological malignancysolid tumorsPK/PD study

Outcome Measures

Primary Outcomes (2)

  • Plasma concentration and pharmacodynamic effects of warfarin

    Samples will be analyzed for S-warfarin and R-warfarin analytes in all evaluable subjects at the end of the trial

    34 days

  • Pharmacokinetic evaluation of belinostat

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

    34 days

Secondary Outcomes (3)

  • Presence of PK analytes for all subjects.

    34 days

  • Safety profile of belinostat given concomitantly with warfarin

    34 days

  • Overall survival of patients

    8 months

Study Arms (1)

Warfarin, Belinostat

EXPERIMENTAL

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

Drug: Belinostat, Warfarin

Interventions

Belinostat, WarfarinDRUG

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

Also known as: PXD101
Warfarin, Belinostat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntsman Cancer Center, University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

belinostatWarfarin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Sunil Sharma, MD, FACP

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2011

First Posted

March 17, 2011

Study Start

December 1, 2010

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

US(1)