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

Phase 1
18 Years
Open (Enrolling)
Solid Tumor, Hematological Malignancy

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Trial Information

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

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.

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

- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Plasma concentration and pharmacodynamic effects of warfarin

Outcome Description:

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

Outcome Time Frame:

34 days

Safety Issue:


Principal Investigator

Sunil Sharma, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

September 2013

Related Keywords:

  • Solid Tumor
  • Hematological Malignancy
  • belionstat
  • warfarin
  • hematological malignancy
  • solid tumors
  • PK/PD study
  • Neoplasms
  • Hematologic Neoplasms



Huntsman Cancer Center, University of UtahSalt Lake City, Utah  84112