Why are we doing this research?
BRIEF SUMMARY:
This study is designed to investigate whether the use of copanlisib is safe, feasible and beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or refractory to standard therapy.
PRIMARY OUTCOME MEASURES:
- The maximum tolerated dose (MTD) [ Time Frame: Approximately 8 months ]
- Phase 1: The highest dose level of copanlisib that can be given so that not more than 1 out of 6 patients experience a DLT during the DLT evaluation period.
- Dose-limiting Toxicities(DLTs) [ Time Frame: Approximately 8 months ]
- Number of participants with Treatment-emergent Adverse Events(TEAEs) [ Time Frame: Approximately 13 months ]
- Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Approximately 13 months ]
- Number of participants with Treatment-related Adverse Events (AEs). [ Time Frame: Approximately 13 months ]
- Objective response rate (ORR) [ Time Frame: Up to 31 months ]
- Phase 2: ORR is the primary efficacy variable in neuroblastoma, Ewing sarcoma and rhabdomyosarcoma.
- Disease control rate (DCR) [ Time Frame: Up to 31 months ]
- Phase 2: DCR is the primary efficacy variable in osteosarcoma.
- Progression-free survival (PFS) [ Time Frame: Up to 31 months ]
- Phase 2: PFS is considered as co-primary (descriptively evaluated) variable in patients with osteosarcoma..
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment