Copanlisib in Solid Tumors or Lymphoma

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The purpose of this study is to find out what is the right dose of copanlisib in children and adolescents, and if your disease responds to this new drug.

Eligibility & Criteria

IRB #:
18-015011
Official Title:
ADVL1721/BAY 80-6946/19176 A non-randomized, open-label, multi-center, Phase I/II study of PI3K inhibitor copanlisib in pediatric patients with relapsed/refractory solid tumors or lymphoma
Study Phase:
Phase I
Phase II
Eligible Age Range:
6 Months - 21 Years
Gender:
All
Study Categories:

Visit Criteria

This study will enroll male and female patients between 6 months and 21 years of age with histologic verification of a solid tumor or lymphoma malignancy at diagnosis for which there is no standard curative anti-cancer treatment or treatment is no longer effective and must have received at least one prior line of therapy. Copanlisib will be given via IV infusion on days 1, 8, and 15 of each 28-day cycle. Study visits will also include the following assessments: tissue submission, blood samples to measure chemistries, blood clotting, screen for infection, and to assess how the body handles the drug (pharmacokinetic studies), ECG, echocardiogram, and study drug administration. In addition to the study visits, subjects will need to come to CHOP frequently for assessments as part of regular cancer care. This includes follow-up visits, blood draws, and scans to monitor any side effects and tumor response.