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

Not Recruiting

Trial ID: NCT01953926


This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors.

Official Title

An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations

Stanford Investigator(s)

James Ford
James Ford

Professor of Medicine (Oncology) and of Genetics and, by courtesy, of Pediatrics


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.


drug: Neratinib

drug: Fulvestrant

drug: Trastuzumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ivy Lau

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