E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Soft Tissue Sarcoma (STS) is a rare group of heterogeneous mesenchymal cancers originating from connective tissue. There are multiple histological subtypes of STS. At present all these subtypes are usually grouped under the heading of STS for the purpose of treatment, although an increasing number of new treatment options are expected to be directed more specifically at individualhistological subtypes. STS metastasizes primarily to the lungs but also to bone, liver and other organs. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10041299 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to investigate the activity of intravenous soblidotin when administered to patients with locally advanced or metastatic STS with prior exposure to doxorubicin containing regimens. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate duration of response, time to tumor progression, 3-month progression-free rate, overall survival time and the quantitative and qualitative toxicities of soblidotin with this schedule. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
♦ Histological evidence of high or intermediate grade malignant progressive or metastatic soft tissue sarcoma ♦ The following tumor types are eligible (WHO classification, 2002, see appendix G) ♦ Adipocytic (liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed-type,NOS) ♦ Fibroblastic (adult fibrosarcoma, myxofibrosarcoma, sclerosing epithelioid fibrosarcoma) ♦ So-called fibrohistiocytic (pleomorphic “MFH”, giant cell “MFH”, inflammatory “MFH”) ♦ Leiomyosarcoma (non-organ origin, uterine origin or skin origin) ♦ Skeletal muscles (rhabdomyosarcoma, alveolar or pleomorphic) excluding embryonal rhabdomyosarcoma ♦ Vascular (epithelioid haemangioendothelioma, angiosarcoma) ♦ Uncertain differentiation (synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, PEComa, intimal sarcoma) excluding chondrosarcoma, Ewing tumors / PNET ♦ Malignant peripheral nerve sheath tumors |
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E.4 | Principal exclusion criteria |
♦ The following tumor types are ineligible ♦ Malignant glomus tumors ♦ Embryonal rhabdomyosarcoma ♦ Chondrosarcoma ♦ Osteosarcoma ♦ Ewing tumors / PNET ♦ Gastro-intestinal stromal tumors ♦ Malignant solitary fibrous tumors ♦ Dermofibromatosis sarcoma protuberans ♦ Inflammatory myofibroblastic sarcoma ♦ Neuroblastoma ♦ Malignant mesothelioma ♦ Mixed mesodermal tumors of the uterus ♦ Other tumors of organ origin, except uterine and skin leiomyosarcoma |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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
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End of study occurs when all of the following criteria have been satisfied: 1. Thirty days after all patients have stopped protocol treatment 2. The trial is mature for the analysis of the primary endpoint as defined in the protocol 3. The database has been fully cleaned and frozen for this analysis |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |