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


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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