Neratinib HER Mutation Basket Study (SUMMIT)

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.

Inclusion Criteria

• Histologically confirmed cancers for which no curative therapy exists.
• Documented HER2 mutation.
• Pediatric patients (at least 12 but less than 18 years of age at signing of informed consent) may be recruited in the Fibrolamellar Carcinoma cohort.

Exclusion Criteria

• Prior treatment with any pan-HER tyrosine kinase inhibitor (eg, lapatinib, afatinib, dacomitinib, neratinib).
• Patients who are receiving any other anticancer agents.
• Symptomatic or unstable brain metastases.
• Women who are pregnant or breast-feeding.

This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification. The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 to 42 days after the last dose of neratinib and a survival follow-up period lasting for a maximum of 12 months for each patient after their last dose of neratinib or until initiation of additional anti-cancer therapy.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Puma Biotechnology, Inc.

• Primary ID PUMA-NER-5201
• Secondary IDs NCI-2014-00495, 2013-002872-42
• Clinicaltrials.gov ID NCT01953926