Study on the Safety and Dosage of Neratinib for Children and Young Adults with Cancer That Has Returned or Not Responded to Treatment

Inclusion Criteria

• Diagnosed with a solid tumor, including brain tumors or lymphoma.
• Cancer has returned or not responded to previous treatments, with no other effective standard treatments available.
• Must have tried at least one previous therapy.
• Must have a tumor that can be measured by specific medical criteria.
• Must provide a tissue sample for analysis.
• Age requirements:
  • Phase 1: Between 3 and 21 years old at enrollment.
  • Phase 2: Between 3 and 21 years old at diagnosis.
• Must meet specific body size requirements based on dose level.
• Must have a performance score of at least 60%.
• Must have adequate heart function as measured by specific tests.
• Female patients of childbearing age must have a negative pregnancy test before starting treatment.
• Must agree to use effective birth control during and after the study.
• Must provide written consent to participate.
• Must be able to swallow tablets or have a feeding tube.
• Must have recovered from any side effects of previous treatments to a mild level before starting the study.

Exclusion Criteria

• Recent treatment with chemotherapy or biological therapy within a short timeframe before starting neratinib.
• Recent radiation therapy, especially to the brain, within a specified period before starting neratinib.
• Previous stem cell transplant if certain conditions are met.
• Inadequate blood cell counts in specific cases.
• High levels of certain liver enzymes or bilirubin.
• Poor kidney function.
• Unstable or symptomatic brain metastases, unless stable on medication.
• Active heart disease or prolonged heart rhythm issues.
• Pregnant or breastfeeding women.
• Currently being treated for another cancer, except for certain skin or cervical cancers.
• Uncontrolled illness or infection, high fever, or psychiatric conditions that could affect study participation.
• Significant digestive disorders causing diarrhea.
• Known HIV or hepatitis infections.
• Allergic reactions to any part of the study drug.