Phase II Study of E7389 Administered as an IV Infusion Day 1 and 8 every 3 Weeks in Pretreated Patients with Advanced and/or Metastatic Soft Tissue SarcomaProtocol Version 5.0 (2010-01-27) - E7389-E044-207

Eisai Limited0 sites160 target enrollmentSeptember 21, 2006

Overview

No summary available.

Registry

who.int

Start Date

September 21, 2006

End Date

June 28, 2012

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Histologically proven advanced and/or metastatic malignant soft tissue sarcoma of high or intermediate grade, and of one of the following histologies (WHO classification 2002\):
•a) Leiomyosarcoma
•b) Adipocytic (liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed\-
•type not otherwise specified)
•c) Synovial sarcoma
•d) Other types of sarcoma, including:
•\-Fibroblastic (adult fibrosarcoma, myxofibrosarcoma, sclerosing epithelioid fibrosarcoma)
•\-So\-called fibrohistiocytic (pleomorphic Malignant Fibrous Histiocytoma
•(MFH), giant cell MFH”, inflammatory MFH”)
•\-Malignant glomus tumors

•1\) Prior history of malignancies other than sarcoma (except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or the patient has been free of any other malignancies for \> 3 years).
•2\) Significant cardiovascular impairment (history of congestive heart failure \> NYHA grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia) please refer appendix C.
•3\) 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) / international normalized ratio (INR) must be closely monitored
•4\) Severe/uncontrolled intercurrent illness/infection
•5\) Patients with a known hypersensitivity to halichondrin B and/or halichondrin B chemical derivative
•6\) Patients who participated in a prior E7389 clinical trial
•7\) Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow\-up schedule; those conditions should be assessed with the patient before registration in the trial.