A Study to Determine the Metabolism and Elimination of Carbon-14 Labeled Eribulin Acetate (14C-Eribulin) in Patients With Advanced Solid Tumors
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Non-Randomized, Single-Center Study to Determine the Metabolism and Elimination of Carbon-14 Labeled Eribulin Acetate (14C-Eribulin) in Patients With Advanced Solid Tumors|
- Excretion Balance of Radio-labeled 14C-eribulin: Total Recovery of Radioactive Dose in Urine and Feces. [ Time Frame: 312 hours postdose ] [ Designated as safety issue: No ]
- Pharmacokinetics: AUC (0-t) for Total Radioactivity in Plasma [ Time Frame: Between Days 1 and 8 of Cycle 1 ] [ Designated as safety issue: No ]Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring total radioactivity exposure.
- Pharmacokinetics AUC (0-t) for Eribulin in Plasma [ Time Frame: Between Days 1 and 8 of Cycle 1 ] [ Designated as safety issue: No ]Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring exposure to eribulin.
|Study Start Date:||March 2009|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Cycle 1 day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on days 1 and 8 every 21 days.
Other Name: E7389
The study will be conducted in two phases, the initial Study phase to administer the radio-labeled 14C-eribulin and collection of PK samples, and the Extension Phase when the patients will continue to receive non-radio-labeled eribulin. In the initial Study phase, patients will receive a single 2 mg flat dose of 14C-eribulin (approximately 80 to 90 microCuries) administered on Cycle 1 Day 1 as an intravenous (IV) bolus injection or infusion over 2-5 minutes. Following this initial dose, patients will remain in the research unit until Day 8 to complete sample collections of urine, blood and feces for PK analysis and determination of 14C-eribulin concentrations between Days 1 and 8.
On Day 8 patients will be re-assessed and discharged, and return on day 15 for physical exam, adverse event evaluation, and lab tests. The patients will then enter the Extension Phase of the study and continue to receive on-radio-labeled eribulin at a dose of 1.4 mg/m^2 on Days 1 and 8 of every 21 day cycle.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908908
|Netherlands Cancer Institute|
|Amsterdam, Netherlands, 1066 CX|
|Study Director:||Barbara Koetz, MSc||Eisai Limited|