A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients

A Single-arm, Multi-center, Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Adult Patients With Advanced Scirrhous Gastric Carcinoma That Have Progressed After One or Two Prior Systemic Treatments

This is a prospective, open-label, single-arm, non-randomized, multi-center, phase II proof of concept (PoC) study with a two-stage design and Bayesian interim monitoring to evaluate efficacy and safety of single agent TKI258 in adult patients with scirrhous gastric carcinoma (SGC) that have progressed after one or two prior systemic treatments.

Inclusion Criteria:

• Diagnosis of advanced/metastatic scirrhous gastric carcinoma
• Evidence of diffusely infiltrating gastric lesions and/or at least one measurable extra-gastric lesion
• Patients previously treated with one or two systemic lines
• Documented radiological confirmation of disease progression
• ECOG performance status of 0 to 2
• Male and female patients aged 20 years or greater
• Adequate liver, renal, and hematologic function

Exclusion Criteria:

• Patients who received prior treatment with an FGFR inhibitor
• Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
• Patients with another primary malignancy within 3 years prior to starting study treatment

Other protocol-defined inclusion/exclusion criteria may apply