METASTATIC SOFT-TISSUE SARCOMAS AFTER FAILURE ON AT LEAST ONE SYSTEMIC THERAPY
Conditions
Brief summary
Phase Ib: to determine the Recommended Phase 2 Dose (RP2D), Phase II: to evaluate 3-month Progression-Free Survival (PFS).
Detailed description
Phase Ib/II: Overall response rate (ORR): complete response (CR) and partial response (PR) as per revised Response Evaluation Criteria in Solid Tumours (RECIST) guidelines (Version 1.1), Clinical benefit (disease control) rate: CR + PR + stable disease (SD), Overall survival (OS), the potential for surgical resectability after L-Annamycin administration, pathological complete response (pCR) if surgical resection occurs and duration of response per RECIST guidelines (Version 1.1).
Interventions
Sponsors
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase Ib: to determine the Recommended Phase 2 Dose (RP2D), Phase II: to evaluate 3-month Progression-Free Survival (PFS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase Ib/II: Overall response rate (ORR): complete response (CR) and partial response (PR) as per revised Response Evaluation Criteria in Solid Tumours (RECIST) guidelines (Version 1.1), Clinical benefit (disease control) rate: CR + PR + stable disease (SD), Overall survival (OS), the potential for surgical resectability after L-Annamycin administration, pathological complete response (pCR) if surgical resection occurs and duration of response per RECIST guidelines (Version 1.1). | — |
Countries
Poland
Outcome results
None listed