drugset / Trial / NCT01576380

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

NCT01576380

Phase 2 Completed 11 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2012-06
Primary completion
2013-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Dovitinib Small molecule 500 mg Oral