Spots Global Cancer Trial Database for A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients
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Trial Identification
Brief Title: A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients
Official Title: 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
Study ID: NCT01576380
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, Nagoya, Aichi, Japan
Novartis Investigative Site, Kashiwa, Chiba, Japan
Novartis Investigative Site, Matsuyama, Ehime, Japan
Novartis Investigative Site, Sapporo-city, Hokkaido, Japan
Novartis Investigative Site, Takatsuki, Osaka, Japan
Novartis Investigative Site, Sunto-gun, Shizuoka, Japan
Novartis Investigative Site, Chuo-ku, Tokyo, Japan
Novartis Investigative Site, Koto, Tokyo, Japan
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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