A Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies
|ClinicalTrials.gov Identifier: NCT01317927|
Recruitment Status : Completed
First Posted : March 17, 2011
Last Update Posted : September 23, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Hematological Malignancy||Drug: Belinostat, Warfarin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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
- Plasma concentration and pharmacodynamic effects of warfarin [ Time Frame: 34 days ]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 ]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 ]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 ]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 ]To evaluate progress-free survival and to assess tumor measurement
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|