An Open-label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification.
18 Years and older, Male and Female
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.
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.