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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Sunil Sharma, MD, FACP
Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope, UT 84112
United States: Food and Drug Administration
|Huntsman Cancer Center, University of Utah||Salt Lake City, Utah 84112|