Patients (18-75 years) with metastatic and/or refractory soft-tissue sarcoma after failure of anthracycline-containing 1st line therapy or with contraindications to anthracyclines (CD13 positivity: grade >/= 1+)
Conditions
Brief summary
for the phase III randomized part: Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumours in cancer immunotherapy trials (iRECIST) as judged by central blinded radiology. iRECIST evaluation because of the observation within preclinical studies and clinical cases, that intratumoral swelling by blood pooling and vascular isruption can occur and lead to pseudoprogressions. Central blinded assessment of PFS is considered the relevant primary efficacy endpoint.
Interventions
DRUGtTF-NGR
DRUGTRABECTEDIN
Sponsors
Universitaet Muenster
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| for the phase III randomized part: Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumours in cancer immunotherapy trials (iRECIST) as judged by central blinded radiology. iRECIST evaluation because of the observation within preclinical studies and clinical cases, that intratumoral swelling by blood pooling and vascular isruption can occur and lead to pseudoprogressions. Central blinded assessment of PFS is considered the relevant primary efficacy endpoint. | — |
Countries
Germany
Outcome results
None listed