Contemporary Characteristics and Outcomes of Pediatric Oncology Patients Participating in Early Phase Clinical Trials.

ABSTRACT:

Background

Phase 1 or phase 1/2 trials are a first step in pediatric cancer drug development. Currently, there is a paucity of information regarding contemporary outcomes for pediatric patients enrolled in these trials. We describe characteristics and outcomes of patients enrolled in pediatric phase 1 clinical trials over a 9-year period at a single institution.

Methods

We queried our clinical trials management system to generate a list of patients enrolled and treated on pediatric phase 1 or phase 1/2 trials from 2011 to 2019. We collected baseline demographics, clinical data, efficacy, and safety endpoints post-enrollment including: time to death, objective response to therapy, duration on therapy, need for dose modification, and occurrence of dose-limiting toxicity. Overa

SUBMITTER: Rami A 

PROVIDER: S-EPMC12415703 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature