A Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies
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.
Drug: Belinostat, Warfarin
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies|
- Plasma concentration and pharmacodynamic effects of warfarin [ Time Frame: 34 days ] [ Designated as safety issue: No ]Samples will be analyzed for S-warfarin and R-warfarin analytes in all evaluable subjects at the end of the trial
- Pharmacokinetic evaluation of belinostat [ Time Frame: 34 days ] [ Designated as safety issue: No ]Pharmacokinetic evaluation of belinostat 1,000 mg/m2 and metabolites in the presence of warfarin 5mg
- Presence of PK analytes for all subjects. [ Time Frame: 34 days ] [ Designated as safety issue: No ]To measure the following analytes of all evaluable subjects at the end of the trial: Belinostat, belinostat glucuronide, methylated belinostat, Beliostat amide, belinostat acid and 3-ASBA.
- Safety profile of belinostat given concomitantly with warfarin [ Time Frame: 34 days ] [ Designated as safety issue: Yes ]To evaluate the safety profile of belinostat given concomitantly with warfarin 5mg. Safety and tolerability assessment include adverse events (AEs), physical examination, vital signs, clinical laboratory tests, and electrocardiograms (ECGs).
- Overall survival of patients [ Time Frame: 8 months ] [ Designated as safety issue: No ]To evaluate progress-free survival and to assess tumor measurement
|Study Start Date:||December 2010|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: 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
Drug: Belinostat, Warfarin
1000 mg/m2 injection infusion given in a 30 min period plus Warfarin 5mg PO
Other Name: PXD101
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317927
|United States, Utah|
|Huntsman Cancer Center, University of Utah|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Sunil Sharma, MD, FACP||Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope, UT 84112|