Trial Outcomes & Findings for A Study to Determine the Metabolism and Elimination of Carbon-14 Labeled Eribulin Acetate (14C-Eribulin) in Patients With Advanced Solid Tumors (NCT NCT00908908)

NCT ID: NCT00908908

Last Updated: 2012-03-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 6 participants
• Primary outcome timeframe: 312 hours postdose
• Results posted on: 2012-03-09

Participant Flow

This study was recruited at 1 center in The Netherlands during the period of Mar 2009 to Jun 2009.

Participant milestones

Measure	Eribulin 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.
Overall Study STARTED	6
Overall Study Adverse Event	0
Overall Study Withdrawl by Subject	0
Overall Study Administrative/Other	0
Overall Study Physician Decision	0
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Determine the Metabolism and Elimination of Carbon-14 Labeled Eribulin Acetate (14C-Eribulin) in Patients With Advanced Solid Tumors

Baseline characteristics by cohort

Measure	Eribulin n=6 Participants 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.
Age Continuous	57.5 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 312 hours postdose

Population: Pharmacokinetic Population

Outcome measures

Measure	14C-eribulin/Eribulin n=6 Participants 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.
Excretion Balance of Radio-labeled 14C-eribulin: Total Recovery of Radioactive Dose in Urine and Feces.	90.4 percent recovery Standard Deviation 11.73

PRIMARY outcome

Timeframe: Between Days 1 and 8 of Cycle 1

Population: Pharmacokinetic Population

Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring total radioactivity exposure.

Outcome measures

Measure	14C-eribulin/Eribulin n=6 Participants 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.
Pharmacokinetics: AUC (0-t) for Total Radioactivity in Plasma	269 ng eq*hr/mL/mg Standard Deviation 153.4

PRIMARY outcome

Timeframe: Between Days 1 and 8 of Cycle 1

Population: Pharmacokinetic Population

Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring exposure to eribulin.

Outcome measures

Measure	14C-eribulin/Eribulin n=6 Participants 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.
Pharmacokinetics AUC (0-t) for Eribulin in Plasma	301 ng eq*hr/mL/mg Standard Deviation 164.9

Adverse Events

Eribulin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Eribulin n=6 participants at risk 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.
Nervous system disorders Headache	33.3% 2/6
Nervous system disorders Dysgeusia	16.7% 1/6
Nervous system disorders Paresthesia	16.7% 1/6
Skin and subcutaneous tissue disorders Alopecia	16.7% 1/6
Skin and subcutaneous tissue disorders Night Sweats	16.7% 1/6
Skin and subcutaneous tissue disorders Scab	16.7% 1/6
Skin and subcutaneous tissue disorders Skin Exfoliation	16.7% 1/6
Gastrointestinal disorders Abdominal Pain Upper	16.7% 1/6
Gastrointestinal disorders Eructation	16.7% 1/6
Gastrointestinal disorders Nausea	16.7% 1/6
Musculoskeletal and connective tissue disorders Back Pain	16.7% 1/6
Musculoskeletal and connective tissue disorders Flank Pain	16.7% 1/6
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 2/6
Blood and lymphatic system disorders Anemia	16.7% 1/6
Cardiac disorders Palpitations	16.7% 1/6
Infections and infestations Pneumonia	16.7% 1/6
Injury, poisoning and procedural complications Accidental Overdose	16.7% 1/6
General disorders Fatigue	66.7% 4/6
General disorders Pyrexia	16.7% 1/6

Additional Information

Eisai Inc.

Eisai Call Center

Phone: 888-422-4743

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place