relapsed / refractory or progressive high risk malignant disease
Conditions
Brief summary
Phase I: Dose Limiting Toxicity (DLT) of the combination treatment, Phase II: Best response (CR or PR) will be based on RANO criteria for all primary CNS tumors and RECIST for non-CNS tumors, defined for each patient as the best response under study combination therapy during the first 6 cycles by central review. Calcified or intra-osseous (osteo)sarcoma target lesions which were progressive before initiation of treatment and show SD on response evaluation will be considered as a responder.
Interventions
DRUGENTINOSTAT
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Universitaetsklinikum Heidelberg AöR
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Dose Limiting Toxicity (DLT) of the combination treatment, Phase II: Best response (CR or PR) will be based on RANO criteria for all primary CNS tumors and RECIST for non-CNS tumors, defined for each patient as the best response under study combination therapy during the first 6 cycles by central review. Calcified or intra-osseous (osteo)sarcoma target lesions which were progressive before initiation of treatment and show SD on response evaluation will be considered as a responder. | — |
Countries
Austria, France, Germany, Netherlands, Sweden
Outcome results
None listed