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Safety and Dose Finding Study of Neratinib in Children and Young Adults With Cancer That Has Returned or Not Responded to Treatment

NCT02932280 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-12-05

No results posted yet for this study

Summary

The purpose of this study is to test the safety of neratinib at different dose levels and to find out what effects, good and bad, it has on the patients and the cancer.

Conditions

Interventions

DRUG

Neratinib

Neratinib will be administered orally, or through existing gastrostomy feeding tube, once a day with food, preferably in the morning, continuously for 28-day cycles, with no rest between cycles. Dose will be scaled by body surface area (BSA).

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • Arkansas Children's Hospital Research Institute

    collaborator OTHER

  • Alberta Children's Hospital

    collaborator OTHER

  • Phoenix Children's Hospital

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • Memorial Sloan Kettering Cancer Center

    lead OTHER

Principal Investigators

  • Tanya Trippett, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02932280 on ClinicalTrials.gov