A Non-randomized, Open-label, Multi-center, Phase I/II Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Copanlisib in Pediatric Patients With Relapsed/Refractory Solid Tumors or Lymphoma
Sponsor: |
Bayer HealthCare |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAR7789 |
U.S. Govt. ID: |
NCT03458728 |
Contact: |
Luca Szalontay: 212-305-9770 / ls3399@cumc.columbia.edu |
The purpose of this study is to find out the effects and safety of an investigational (experimental) new drug called copanlisib in pediatric patients from 6 months to 21 years of age. This study consists in two-phase, Phase I part will determine which is the right dose of copanlisib to be used in children/adolescents/adults with relapsed (has returned) or refractory (did not respond to standard treatment) solid tumor or lymphoma. Phase II part will further evaluate the effects and safety in pediatric patients with relapsed or refractory neuroblastoma, ostesarcoma, rhabdomyosarcoma and Ewing sarcoma. Patients will receive copanlisib intravenous (IV) infusion on Day 1, Day 8, and Day 15 of every 28-day treatment cycle. The study, Phase I and Phase II parts, is composed of the following periods: Screening; Treatment; Active follow-up; Long-term follow-up.
This study is closed
Investigator
Luca Szalontay, MD
Is your child between 6 months and 17 years of age? |
Yes |
No |
Does your child have disease that has relapsed or does not respond therapy for which no standard therapy is available? |
Yes |
No |