NCT01583777

Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer

A Phase 1 Study for the Evaluation of Excretion (Mass Balance) and Pharmacokinetics of 14C-Labeled Belinostat in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Acrotech Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to study the mass balance, pharmacokinetics (PK), and safety of belinostat following IV administration in patients with a recurrent or progressive malignancy.

Detailed description

This is a Phase 1, open-label, single-dose study of 14C-labeled belinostat to determine routes of elimination of belinostat. A single dose of 14C-labeled belinostat (approximately 94.3 to 105 µCi, 1500 mg) will be administered as a 30-minute IV infusion to the patient. Routes of elimination of belinostat and its metabolites will be assessed by estimating the recovery of total radioactivity and parent belinostat over a period of 7 days. Plasma samples will be taken for 3 days at specified intervals for PK assessments. Total radioactivity in plasma, urine, and feces will be determined by liquid scintillation counting. Concentrations of belinostat in plasma and urine will be determined using a validated liquid chromatography - tandem mass spectroscopy (LC-MS/MS) method. Selected plasma, urine, and feces samples will be retained for use in the metabolism investigation. Samples will be initially analyzed using radio-high performance liquid chromatography (HPLC) to determine the number and relative proportion of belinostat and metabolites present. Selected samples will be subsequently analyzed using LC-MS to identify the major metabolites (\> 10% of parent area under the curve \[AUC\]). If it is in the interest of the patient, treatment with non-radiolabeled belinostat may be continued with 21-day cycles until disease progression, initiation of new anticancer therapy, or an adverse event (AE) that may affect patient participation.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	Belinostat	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.

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2012-04-24
• Last updated: 2020-01-03

Locations

1 site across 1 country: Spain