Trial Search Results

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

This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in patients with ERBB mutation-positive or EGFR gene-amplified solid tumors.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Puma Biotechnology, Inc.

Stanford Investigator(s):


  • Drug: Neratinib
  • Drug: Fulvestrant
  • Drug: Trastuzumab


Phase 2


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ivy Lau
Not Recruiting