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 Sarcoma

Phase 1

• Conditions: Advanced and/or metastatic soft tissue sarcoma; MedDRA version: 9.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas

• Registration Number: EUCTR2005-004272-20-FR
• Lead Sponsor: Eisai Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-09-04
• Study Completion: 2012-06-28
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

- Histologically proven advanced and/or metastatic malignant soft tissue sarcoma of high or intermediate grade, and of one of the following histologies: leiomyosarcoma, adipocytic, synovial sarcoma and other type of sarcoma.
- Presence of measurable disease (as defined by RECIST)
- Evidence of objective progression within the last 6 months (RECIST)
- Patients must have received no more than one combination or two single agent chemotherapy regimens for advanced disease; (neo)adjuvant therapy is not counted towards this requirement
- WHO performance status 0 or 1
- Adequate bone marrow, hepatic, renal and cardiac functions
- Written informed consent must be given

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Prior history of malignancies other than sarcoma
- Significant cardiovascular impairment
- Parients who are receiving anti-coagulant therapy with warfarin or related compounds
- Severe/uncontrolled intercurrent illness/infection
- Hypersensitivity to halichondrin B and/or halichondrin B chemical derivative
- Patients who participated in a prior E7389 clinical trial
- Any condition potentially hampering compliance with the study protocol and follow-up schedule

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: ;Primary end point(s): Progression free survival, assessed 12 weeks after start of treatment. Progression will be defined according to RECIST criteria;Main Objective: To evaluate the therapeutic activity and safety of E7389 at a dose 1,4mg/m(2) on days 1 and 8 every 3 weeks in patients with adavanced and/or metastatic soft tissue sarcoma who have relapsed following standard therapies