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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Neratinib HER Mutation Basket Study

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.
Bladder, Colon, Esophageal, Gastric/Gastroesophageal, Neuro-Oncology, Ovarian, Urologic, Uterine
Phase II
Chemotherapy - cytotoxic, Hormonal Therapy, Mol. targeted/Immunotherapy/Biologics
Fulvestrant, Neratinib (HKI-272), Paclitaxel, Trastuzumab (Herceptin)
Mayer, Ingrid
Vanderbilt University


18 Years
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, tucatinib, poziotinib)

Participants who are receiving any other anticancer agents

Symptomatic or unstable brain metastases

Women who are pregnant or breast-feeding

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trials, call 1-800-811-8480 or complete
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