advanced myxoid/round cell liposarcoma pretreated with anthracycline and ifosfamide MedDRA version: 9.1 Level: LLT Classification code 10024627 Term: Liposarcoma
Conditions
Interventions
Product Name: Trabectedin
Product Code: ET743
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Trabectedin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
ISTITUTO NAZIONALE PER LA CURA TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven myxoid/round cell liposarcoma. 2) Locally advanced and/or metastatic disease. 3) Previous treatment with an anthracycline and ifosfamide, administered either in combination or as sequential therapies. 4) Measurable disease, as defined by RECIST criteria. 5) ECOG PS = 18 years. 7) Pathology specimens available for centralized review. 8) Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or lower. 9) Adequate haematological function. 10) Adequate renal function. 11) Adequate liver function. 12) Signed informed consent. 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: 1) Pregnant or breast-feeding women, or subjects (male or female) not employing adequate contraception. 2) Prior exposure to Trabectedin. 3) Less than 3 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent. 4) History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse. 5) Known CNS metastases. 6) Active major infection. 7) Other serious concomitant illnesses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective will be to assess the response rate to Trabectedin of patients with locally advanced/metastatic MRCL pretreated with anthracycline/ifosfamide-based chemotherapy. Patterns of tumor response will be described, with a view to non-dimensional responses;Secondary Objective: Secondary objectives will be to evalutate efficacy and toxicity profile of Trabectedin in advanced, pretreated myxoid/round cell liposarcoma patients;Primary end point(s): 1. the tumor response rate 2. the patterns of tumor response | — |
Countries
Italy
Outcome results
None listed