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Sponsored by: |
Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00706095 |
This is an open-label, three-parallel group pharmacokinetic study. Patients with advanced solid tumors will be assigned to one of three groups to receive I.V. doses of eribulin (E7389). The three groups are: normal hepatic function, mild hepatic impairment (Child-Pugh A) and moderate hepatic impairment (Child-Pugh B) according to the Child-Pugh System for classifying hepatic impairment.
Condition | Intervention | Phase |
---|---|---|
Cancer |
Drug: E7389 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label, Parallel Group Study to Explore the Pharmacokinetics of Eribulin Mesylate (E7389) in Patients With Advanced Solid Tumors and Normal or Reduced Hepatic Function According to the Child-Pugh System |
Estimated Enrollment: | 18 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: E7389
Intravenous injection; starting doses on day 1 are 0.7 mg/m^2 and 1.0 mg/m^2 for moderate and mild hepatic dysfunction and 1.4 mg/m^2 for normal hepatic function.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Additional Inclusion Criteria for the Group of Patients with No Hepatic Impairment:
Additional Inclusion Criteria for the Group of Patients with Hepatic Impairment:
All the general inclusion criteria listed above plus:
Exclusion Criteria:
Patients who have received any of the following treatments within the specified period before E7389 treatment start:
Contact: Jantien Wanders, MD | 44-208-600-1400 |
Netherlands | |
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | Recruiting |
Amsterdam, Netherlands, 1066 CX | |
Utrecht Medical Centre | Recruiting |
Utrecht, Netherlands |
Principal Investigator: | Prof. JHM Schellens | National Cancer Institute-Antoni van Leuwenhoek Hospital |
Responsible Party: | Eisai Limited ( Jantien Wanders, MD ) |
Study ID Numbers: | E7389-E044-108 |
Study First Received: | February 4, 2008 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00706095 |
Health Authority: | European Union: European Medicines Agency |