Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer
|ClinicalTrials.gov Identifier: NCT01583777|
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : July 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Drug: Belinostat||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study for the Evaluation of Excretion (Mass Balance) and Pharmacokinetics of 14C-Labeled Belinostat in Patients With Advanced Cancer|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
On Day 1, a single dose of 14C-labeled belinostat (approximately 94 to 105 µCi, 1500 mg) will be administered to the patient as a 30-minute IV infusion.
After Cycle 1 evaluations are completed, and if it is in the best interest of the patient, patients may receive additional cycles of non-radiolabeled belinostat until disease progression, unacceptable toxicity, or initiation of new anticancer therapy. After Cycle 1, Day 21, non radiolabeled belinostat will be administered IV as a 30 -45 minute infusion of 1000 mg/m2 on Days 1 through 5 every 21 days.
- Maximum recovery of the radioactive dose in urine and feces [ Time Frame: 6 months ]The route of elimination of belinostat will be determined by the recovery of total radioactivity (parent drug and metabolites) and unmetabolized belinostat in urine and feces following single IV administration of 14C-labeled belinostat in patients with recurrent or progressive malignancy.
- The Concentration of Belinostat in plasma, urine, and feces and its metabolites [ Time Frame: 6 months ]Secondary objectives are to determine the PK of 14C-labeled belinostat in plasma, urine, and feces following IV administration; to determine the relative proportion of 14C-labeled belinostat and its radiolabeled metabolites in plasma, urine, and feces; and to assess the safety of belinostat.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583777
|Hospital Universitario Madrid Sanchinarro|
|Madrid, Spain, 28050|
|Study Director:||Mi Rim Choi, MD||Spectrum Pharmaceuticals, Inc|