EUCTR2007-000035-25-FR
Active, not recruiting
Phase 1
A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis®) in Patients with Localized Myxoid / Round Cell Liposarcoma
Pharma Mar, S.A.0 sites22 target enrollmentApril 5, 2007
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ocalized myxoid / round cell liposarcoma previously untreated with chemotherapy or radiation
- Sponsor
- Pharma Mar, S.A.
- Enrollment
- 22
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient´s written informed consent before any study\-specific procedure
- •Adult patients (\= 18 years)
- •Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of
- •pathology specimens for central review and pharmacogenomic studies
- •Clinical evidence of localized, non\-metastatic tumor, including locally recurring
- •disease after initial surgery
- •Measurable disease (by RECIST)
- •No prior chemotherapy or radiation (except for adjuvant post\-operative
- •radiotherapy)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0\-2
Exclusion Criteria
- •Known hypersensitivity to any of the components of the trabectedin i.v.
- •formulation or dexamethasone
- •Pregnant or lactating women or any patient of childbearing potential who are not
- •employing adequate contraception
- •History of another neoplastic disease (except basal cell carcinoma or cervical
- •carcinoma in situ adequately treated) unless in remission for 5 years or longer
- •Known distant metastases
- •Other serious illnesses such as congestive heart failure or angina pectoris,
- •myocardial infarction within 1 year before enrollment, uncontrolled arterial
- •hypertension or arrhythmias
Outcomes
Primary Outcomes
Not specified
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