EUCTR2005-004272-20-FRActive, not recruitingPhase 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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Eisai Limited
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
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
- •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
Investigators
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