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RecruitMe Clinical Trial

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
Enrolling:Male and Female Patients
Age Range:Between 18 and 21 years old
IRB Number:AAAR7789
U.S. Government ID:NCT03458728
Contact: Rebecca Zylber, NP: 212-305-7212 / rjv2107@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.

Do You Qualify?
Are you between the ages of 18-21?YesNo
Do you have disease that has relapsed or does not respond to therapy for which no standard therapy is available?YesNo
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Investigator
Alice Lee, MD
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You may be eligible for this study

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Who Can I Contact?
For more information, please contact:
Rebecca Zylber, NP
Email: rjv2107@cumc.columbia.edu
Phone: 212-305-7212