TRABTRAP Sarkom

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 was a safety run-in part. The final dose of tTF-NGR established as safe in this safety run-in part is 0.5 mg/m2 per day for 2 consecutive days following each trabectedin infusion and is used for the randomized (parallel 1:1; Arm 1: standard trabectedin, Arm 2: standard trabectedin plus tTF-NGR) phase III part of this trail. . Further dose modification for tTF-NGR is possible.

{ "short_title": "TRABTRAP Sarkom", "data_mode": "900", "data_mode_number": "000002192", "official_title": "Phase III Study Comparing Trabectedin (T) versus Trabectedin plus tTF-NGR to Entrap T inside the Tumor in Patients with Metastatic and/or Refractory Soft Tissue Sarcoma (STS; 2nd Line)\r\n", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "not_applicable", "therapielinie_value": "second", "ctgov_number": "NCT05597917", "eudract_number": null, "general_contact_email": "oncostudy@ukdd.de", "general_contact_phone": "+49 351-4587666", "hauptpruefer_dd_name": "Dr. med. Stephan Richter", "description_laie_de": "Ziel der Studie ist der Vergleich der Wirksamkeit und der Sicherheit von tTF-NGR in Kombination mit Trabecetedin im Vergleich zu Trabectedin allein bei Patienten mit irresektablem oder metastasiertem Weichteilsarkom, welches unter einer oder mehreren systemischen Vorbehandlungen, einschlie\u00dflich mindestens einer anthrazyklinhaltigen Therapie, progredient ist. Weiterhin wird die Sicherheit und Vertr\u00e4glichkeit von tTF-NGR untersucht.", "description_laie_en": "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 was a safety run-in part. The final dose of tTF-NGR established as safe in this safety run-in part is 0.5 mg/m2 per day for 2 consecutive days following each trabectedin infusion and is used for the randomized (parallel 1:1; Arm 1: standard trabectedin, Arm 2: standard trabectedin plus tTF-NGR) phase III part of this trail. . Further dose modification for tTF-NGR is possible.", "description_expert_de": "Ziel der Studie ist der Vergleich der Wirksamkeit und der Sicherheit von tTF-NGR in Kombination mit Trabecetedin im Vergleich zu Trabectedin allein bei Patienten mit irresektablem oder metastasiertem Weichteilsarkom, welches unter einer oder mehreren systemischen Vorbehandlungen, einschlie\u00dflich mindestens einer anthrazyklinhaltigen Therapie, progredient ist. Weiterhin wird die Sicherheit und Vertr\u00e4glichkeit von tTF-NGR untersucht.", "description_expert_en": "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 was a safety run-in part. The final dose of tTF-NGR established as safe in this safety run-in part is 0.5 mg/m2 per day for 2 consecutive days following each trabectedin infusion and is used for the randomized (parallel 1:1; Arm 1: standard trabectedin, Arm 2: standard trabectedin plus tTF-NGR) phase III part of this trail. . Further dose modification for tTF-NGR is possible.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "III", "main_cat_id": 9, "sub_cat_id": 43 }