EUCTR2005-004272-20-FR
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Eisai Limited
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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