E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
advanced myxoid/round cell liposarcoma pretreated with anthracycline and ifosfamide |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024627 |
E.1.2 | Term | Liposarcoma |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives will be to evalutate efficacy and toxicity profile of Trabectedin in advanced, pretreated myxoid/round cell liposarcoma patients |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 <=2. 6) Age >= 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. |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. the tumor response rate 2. the patterns of tumor response |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |