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

NCT00908908 | Completed Phase 1 Results

• 1 other identifier: E7389-E044-103
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Keywords

Advanced Solid Tumors; Failure of Multiple Prior Chemotherapy Regimens

Outcome Measures

Primary Outcomes (3)

• Excretion Balance of Radio-labeled 14C-eribulin: Total Recovery of Radioactive Dose in Urine and Feces.

  312 hours postdose

• Pharmacokinetics: AUC (0-t) for Total Radioactivity in Plasma

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

  Between Days 1 and 8 of Cycle 1

• Pharmacokinetics AUC (0-t) for Eribulin in Plasma

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

  Between Days 1 and 8 of Cycle 1

Study Arms (1)

1

EXPERIMENTAL

Drug: eribulin

Interventions

eribulin DRUG

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.

Also known as: E7389

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must be aged 18 years or older.
• Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1, or 2.
• 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).
• 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.
• 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.
• Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or below, except for stable sensory neuropathy ≤ Grade 2 and alopecia.
• Patients must be willing and able to comply with the study protocol for the duration of the study.
• 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.

You may not qualify if:

• 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
• Have had radiation therapy encompassing \> 30% of marrow.
• Have received prior treatment with mitomycin C or nitrosourea.
• Have had major surgery within 4 weeks before starting study treatment
• Patients with pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
• 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.
• Patients with meningeal carcinomatosis.
• 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.
• 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.
• Patients with severe/uncontrolled intercurrent illness/infection.
• 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).

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

MeSH Terms

Interventions

eribulin

Results Point of Contact

• Title: Eisai Inc.
• Organization: Eisai Call Center

888-422-4743

Study Officials

• Barbara Koetz, MSc

  Eisai Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 27, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 9, 2012
• Results First Posted: January 27, 2012

Record last verified: 2012-03

Locations

NL (1)