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

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: NCT00908908
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : January 27, 2012
Last Update Posted : March 9, 2012
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Tracking Information
First Submitted Date  ICMJE May 20, 2009
First Posted Date  ICMJE May 27, 2009
Results First Submitted Date  ICMJE December 22, 2011
Results First Posted Date  ICMJE January 27, 2012
Last Update Posted Date March 9, 2012
Study Start Date  ICMJE March 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
  • Excretion Balance of Radio-labeled 14C-eribulin: Total Recovery of Radioactive Dose in Urine and Feces. [ Time Frame: 312 hours postdose ]
  • Pharmacokinetics: AUC (0-t) for Total Radioactivity in Plasma [ Time Frame: Between Days 1 and 8 of Cycle 1 ]
    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 ]
    Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring exposure to eribulin.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2009)
Excretion balance and metabolic pathway of radio-labeled 14C-eribulin as determined by pharmacokinetics (PK) analysis of plasma, blood, urine, and feces. [ Time Frame: Between Days 1 and 8 of Cycle 1 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2009)
  • Safety and tolerability of eribulin determined by collection of adverse events (AEs), laboratory parameters, concomitant medications, electrocardiogram (ECG), physical examinations and vital signs. [ Time Frame: For every 21-day cycle, AEs and concomitant medications recorded throughout; lab measurements, physical exam and vital signs between Days 1 & 15; ECGs measured at Day 8 of Cycle 2. ]
  • Efficacy of eribulin determined by objective tumor response as measured by Response Evaluation Criteria in Solid Tumors (RECIST). [ Time Frame: Day 15 assessments during Extension Phase: at intervals according to center's usual practice or sooner if progressive disease. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Metabolism and Elimination of Carbon-14 Labeled Eribulin Acetate (14C-Eribulin) in Patients With Advanced Solid Tumors
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine the metabolism and elimination of carbon-14 labeled eribulin acetate (14C-eribulin) in patients with advanced solid tumors.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE Drug: 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.
Other Name: E7389
Study Arms  ICMJE Experimental: 1
Intervention: Drug: eribulin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2011)
6
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2009)
10
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Patients must have a histologically or cytologically confirmed advanced solid tumor that has progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy). Patients with measurable tumors according to RECIST are desirable but not essential.
  2. Patients must be aged 18 years or older.
  3. Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1, or 2.
  4. Patients must have adequate renal function as evidenced by serum creatinine ≤135 µM/L (≤1.5 mg/dL) or creatinine clearance >= 40 mL/minute (min).
  5. Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >= 1.5 x 10^9/L and platelet count >= 100 x 10^9/L.
  6. Patients must have adequate hepatic function as evidenced by bilirubin ≤ 1.5 times the upper limit of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3 x ULN (in the case of liver metastases ≤ 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.
  7. Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or below, except for stable sensory neuropathy ≤ Grade 2 and alopecia.
  8. Patients must be willing and able to comply with the study protocol for the duration of the study.
  9. Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.

Exclusion Criteria:

  1. Patients who have received any of the following treatments within the specified period before treatment start:

    • chemotherapy, radiation, or biological therapy within three weeks
    • hormonal therapy within one week
    • any investigational drug within 4 weeks
    • systemic unconventional or alternative therapies including, but not limited to, herbal remedies within 4 weeks
  2. Have had radiation therapy encompassing > 30% of marrow.
  3. Have received prior treatment with mitomycin C or nitrosourea.
  4. Have had major surgery within 4 weeks before starting study treatment
  5. Patients with pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
  6. Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (e.g., radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks.
  7. Patients with meningeal carcinomatosis.
  8. Patients who are receiving anti-coagulant therapy with warfarin or related compounds, other than for line patency, and cannot be changed to heparin-based therapy, are not eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT) or international normalized ratio (INR) must be closely monitored.
  9. Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Peri-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  10. Patients with severe/uncontrolled intercurrent illness/infection.
  11. Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association (NYHA) grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia).
  12. Patients with organ allografts requiring immunosuppression.
  13. Patients with known positive HIV status.
  14. Patients with pre-existing neuropathy > Grade 2.
  15. Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.
  16. Patients who participated in a prior eribulin clinical trial, whether or not they received eribulin (E7389).
  17. Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00908908
Other Study ID Numbers  ICMJE E7389-E044-103
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Barbara Koetz, MSc Eisai Limited
PRS Account Eisai Inc.
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP