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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 (BAY 80-6946 /19176)

Study category: Cancer

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Details
Age

Child to Adult

Phase

I/II - A combination of phases: (1) Research Studies that focus on the safety of a drug. The goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These studies usually involve a small number of participants; and (2) Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Location

Childrens Hospital Colorado

Principal Investigator
Margaret Macy,  MD

Margaret Macy, MD

Study ID

Protocol Number: 17-1495

ClinicalTrials.gov: NCT03458728

Categories

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