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Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

About

Brief Summary

This study is directed toward subjects with malignant brain tumors that have returned after initially successful treatment. The purpose of this research study is to see if the experimental drug neratinib has benefits at certain dose levels. The researchers want to find out what effects (good and bad) neratinib has on subject’s brain tumors with EGRF genetic modification. Neratinib binds and blocks a family of proteins called the epidermal growth factor receptor (EGFR). EGFR is part of a pathway that helps cells to function normally. In some types of cancers, this pathway becomes too active, which can cause tumor cell growth. Neratinib has been shown to have antitumor activity in laboratory and animal studies and is being tested in human clinical studies. Neratinib has not been approved by the U.S. Food and Drug Administration (FDA). It is only available on a clinical study such as this trial.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Adult subjects with malignant brain tumors, that indicate EGFR genetic modification, have returned after initially successful treatment. \n\n For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Inclusion Criteria:

  • Provide written informed consent
  • Histologically confirmed cancers for which no curative therapy exists
  • Documented HER2 or EGFR exon 18 mutation
  • Participants must agree and commit to use appropriate methods of contraception as outlined in the protocol
  • At least one measurable lesion, defined by RECIST v1.1

Exclusion Criteria:

  • Participants harboring ineligible somatic HER2 mutations
  • Prior treatment with any HER2-directed tyrosine kinase inhibitor (e.g., lapatinib, afatinib, dacomitinib, neratinib) is excluded with the following exception: patients with EGFR exon 18 mutated NSCLC who may have received afatinib, osimertinib, or other pan HER or EGFR TKIs remain eligible
  • Participants who are receiving any other anticancer agents
  • Symptomatic or unstable brain metastases
  • Women who are pregnant or breast-feeding

There are additional inclusion and exclusion criteria. The study center will determine if

criteria for participation are met.

Join this Trial

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Study Stats
Protocol No.
13-001869
Category
Hematology-Oncology
Oncology
Contact
Jonathan Goldman
Location
  • UCLA Parkside
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT01953926
For detailed technical eligibility, visit ClinicalTrials.gov.