Condition: Soft Tissue Sarcoma · Sponsor: Universität Münster
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.
This description comes directly from the study's public registry record.
Christoph Schliemann, Prof. Dr. · +49 251 83 45363 · Christoph.Schliemann@ukmuenster.de
Torsten Kessler, PD Dr. · +49 251 83 45363 · Torsten.Kessler@ukmuenster.de
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| HELIOS Klinikum Bad Saarow | Bad Saarow, Germany | Recruiting |
| HELIOS Klinikum Berlin-Buch | Berlin, Germany | Recruiting |
| TU Dresden Medizinische Fakultät Carl Gustav Carus | Dresden, Germany | Recruiting |
| Medizinische Hochschule Hannover | Hanover, Germany | Recruiting |
| Universitätsklinikum Heidelberg | Heidelberg, Germany | Recruiting |
| Universitätsmedizin Mainz | Mainz, Germany | Recruiting |
| Klinikum rechts der Isar der technischen Universität München | München, Germany | Recruiting |
| LMU Klinikum | Münich, Germany | Recruiting |
| University Hospital Muenster, Germany | Münster, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05597917