Metastatic Gastric Cancer Clinical Trial
Official title:
An Open-label, Uncontrolled Phase II Trial of HDAC-Inhibitor LBH589 in Patients With Chemo-refractory Metastatic Gastric Cancer Overexpressing Histone Deacetylases (HDACs) - CLBH589BDE03T
This is an open-label, phase II trial evaluating the antitumor activity and safety of the
oral Histone Deacetylase (HDAC)-Inhibitor LBH589. The treatment consists of 20 mg LBH589
three times a week in patients with chemo-refractory HDAC overexpressing.
metastatic adenocarcinoma of stomach, esophagogastric junction or lower esophagus (Barrett
carcinoma). One cycle lasts 21 days. A total of 28 patients will be enrolled in this trial.
In patients experiencing LBH589-related toxicity requiring treatment rest or dose reduction
dose may be reduced. Subsequent dose adjustment will be permitted based on outcome.
Treatment will continue until disease progression or intolerable adverse events.
Subsequently, the patients will be followed-up for one year.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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