TTF-NGR Randomized Study - STS

ABSTRACT: In this phase III open label, controlled clinical trial patients with unresectable or metastatic soft-tissue sarcoma after failure of anthracycline-containing first line therapy or with contraindications to these drugs and CD13 positivity in central histology (grade >/= 1+) are treated to evaluate whether tTF-NGR in combination with standard trabectedin chemotherapy prolongs progression-free survival (according to iRECIST), as compared with trabectedin alone. Further objectives are to evaluate the efficacy of tTF-NGR in combination with standard trabectedin chemotherapy with respect to the response rate and overall survival as well as to assess the safety profile of tTF-NGR combined with trabectedin. Before the randomized phase III part of the study, there will be a safety run-in part. The final dose of tTF-NGR established as safe in this safety run-in part will be used for the randomized (parallel 1:1; Arm 1: standard trabectedin, Arm 2: standard trabectedin plus tTF-NGR) phase III part of this trail.

DISEASE(S): Fibrosarcoma,Round Cell Liposarcoma,Leiomyosarcoma Metastatic,Leiomyosarcoma Recurrent,Angiosarcoma,Liposarcoma Stage Unspecified,Myxoid Liposarcoma,Liposarcomas Malignant,Rhabdomyosarcomas,Leiomyosarcoma Nos,Hepatic Angiosarcoma,Skin Angiosarcoma,Angiosarcoma Recurrent,Fibrosarcoma Nos,Rhabdomyosarcoma Previously Untreated,Lymphangiosarcomas,Uterine Leiomyosarcoma,Rhabdomyosarcoma Nos,Undifferentiated Sarcoma,Pleomorphic Liposarcoma,Myxoid Liposarcoma Metastatic,Soft Tissue Sarcoma,Haemangiosarcoma Nos,Breast Angiosarcoma Metastatic,Alveolar Rhabdomyosarcoma,Leiomyosarcoma,Myxofibrosarcoma,Rhabdomyosarcoma Recurrent,Angiosarcoma Nos,Liposarcoma Metastatic,Synovial Sarcoma Recurrent,Pleomorphic Leiomyosarcoma,Synovial Sarcoma Nos,Testicular Leiomyosarcoma,Rhabdomyosarcoma,Mixed-type Liposarcoma,Fibrosarcoma Metastatic,Dedifferentiated Liposarcoma,Leiomyosarcomas,Synovial Sarcoma,Small Intestine Leiomyosarcoma,Synovial Sarcoma Non-metastatic,Haemangiosarcoma,Liposarcoma Nos,Rhabdomyosarcoma Previously Treated,Angiosarcoma Nonmetastatic,Liposarcoma Non-metastatic,Fibrosarcoma Stage Unspecified,Synovial Sarcoma Metastatic,Lymphangiosarcoma Nos,Sarcoma,Hemangiosarcoma,Fibrosarcoma Non-metastatic,Breast Angiosarcoma,Angiosarcoma Stage Unspecified,Leiomyosarcoma Non-metastatic,Liposarcoma Recurrent,Patients (18-75 Years) With Metastatic And/or Refractory Soft-tissue Sarcoma After Failure Of Anthracycline-containing 1st Line Therapy Or With Contraindications To These Drugs (cd13 Positivity: Grade >/= 1+).,Lymphangiosarcoma,Liposarcoma,Cholangiosarcoma,Fibrosarcomas Malignant,Angiosarcoma Non-metastatic,Angiosarcoma Metastatic

PROVIDER: 2752784 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR