A Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|