A phase II study of intravenous TZT-1027, administered weekly times two, every three weeks, to patients with advanced or metastatic soft tissue sarcomas (STS) with prior exposure to doxorubicin-based chemotherapy

Phase 1

• Conditions: 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 version: 7.0Level: HLGTClassification code 10041299

• Registration Number: EUCTR2004-001108-11-DE
• Lead Sponsor: European Organisation for the Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-09-23
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 28

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

? 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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