tTF-NGR Randomized Study - STS
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 c
| Condition(s) | Soft Tissue Sarcoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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 fi |
| Who can participate | Inclusion Criteria: 1. Patients of all genders (female, male, diverse), with no restriction regarding ethnic or religious background age 18 - 75 years. 2. Patients with advanced or metastatic soft-tissue sarcoma after failure of anthracycline-containing first line therapy (or anthracycline-containing adjuvant therapy within 12 months before entry on study) or with contraindications to these drugs 3. Patients must have histological evidence of high-grade advanced unresectable or metastatic soft tissue sarcoma (grade 2 - 3) according to the FNCLCC grading system. The following tumor types are included: * Dedifferentiated liposarcoma * Myxoid liposarcoma (high grade) * Pleomorphic liposarcoma * Adult fibrosarcoma * Myxofibrosarcoma (high-grade) * Leiomyosarcoma * Rhabdomyosarcoma (alveolar, p |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Universität Münster |
| Locations | Bad Saarow, Germany; Berlin, Germany; Dresden, Germany; Hanover, Germany; Heidelberg, Germany; Mainz, Germany (+3 more sites) |
| Start date | 2021-10-26 |
| NCT ID | NCT05597917 |
| Official listing | https://clinicaltrials.gov/study/NCT05597917 |