A Phase I/II Study of Neratinib in Children and Adolescents with Recurrent or Persistent Cancer


Full Title

A Phase I/II Study of Neratinib in Pediatric Patients with Relapsed or Refractory Solid Tumors


HER2 is a protein which, when abnormal (mutated), can fuel cancer growth. Neratinib is a drug that blocks some of the functions of the HER2 protein. In this study, researchers are evaluating the safety and effectiveness of neratinib in children and adolescents with solid tumors and blood cancers that have continued to grow or came back despite prior treatment. Neratinib is taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be at least 6 years old and no older than 21.
  • Patients must have a solid tumor or blood cancer that has continued to grow or came back despite treatment with at least one prior therapy.
  • Patients may not have previously received treatment that included a drug that targets HER2, such as lapatinib.
  • Patients must recover from the serious side effects of previous treatments before entering the study.

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.




Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID