Localized myxoid / round cell liposarcoma previously untreated with chemotherapy or radiation MedDRA version: 9.1 Level: LLT Classification code 10024630 Term: Liposarcoma non-metastatic
Conditions
Interventions
Product Name: YONDELIS® (trabectedin)
Product Code: ET-743
RWJ-680581
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: trabectedin
CAS Number: 114899-77-3
Current Sponsor code: ET-743
Other descriptive name: Ecteinascidin 743
Concent
Sponsors
Pharma Mar, S.A.
Eligibility
Sex/Gender
All
Inclusion 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 (appendix 1) • Hematologic variables: o Hemoglobin = 9 g/dL o Absolute neutrophil count (ANC) = 1,500/µL, and o Platelet count = 100,000/µL • Serum creatinine 30 mL/min • Creatinine phosphokinase (CPK) 2.5 ULN consider alkaline phosphatase liver fraction or GGT or 5’ nucleotidase must be 25 g/L 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
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 • Psychiatric disorder that prevents compliance with protocol • Active viral hepatitis or chronic liver disease • Active infection • Any other unstable medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To determine the pathological complete response (pCR) rate with trabectedin in patients with localized myxoid / round cell liposarcoma (MRCL). ;Secondary Objective: - Evaluate the objective response rate by RECIST and contrast such response with changes in radiological density and tumor pathology. - Describe the incidence and severity of adverse events in this patient population. - Exploratory, hypothesis-generating pharmacogenomic analyses to correlate molecular parameters in patient samples with clinical outcomes (pCR).;Primary end point(s): Pathological Complete Response (pCR) rate | — |
Countries
France, Germany, Italy
Outcome results
None listed