Spots Global Cancer Trial Database for Histone Deacetylases - Gastric Cancer (HDAC-GaCa-2008)
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Trial Identification
Brief Title: Histone Deacetylases - Gastric Cancer (HDAC-GaCa-2008)
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
Study ID: NCT01528501
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Klinikum rechts der Isar, Munic, Bavaria, Germany
Universitätsklinikum Mannheim, Mannheim, , Germany
Contact Details
Name: Martina Mayr, Dr.
Affiliation: Klinikum rechts der Isar
Role: PRINCIPAL_INVESTIGATOR
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