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. MedDRA ver
Conditions
Interventions
Product Name: soblidotin
Product Code: TZT-1027
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: soblidotin
CAS Number: 149606-27-9
Current Sponsor code: TZT-1027
Concentration unit: mg/
Sponsors
European Organisation for the Research and Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
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 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: ? 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): Objective tumor response | — |
Countries
Germany
Outcome results
None listed