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
Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients (ages 18-21)
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
Additional Study Information: 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.
Investigator
Luca Szalontay, MD
Do You Qualify?
Are you between the ages of 18-21? Yes No
Do you have disease that has relapsed or does not respond to therapy for which no standard therapy is available? Yes No
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For more information, please contact:
Luca Szalontay
ls3399@cumc.columbia.edu
212-305-9770