NCT01528501

Histone Deacetylases - Gastric Cancer (HDAC-GaCa-2008)

An Open-label, Uncontrolled Phase II Trial of HDAC-Inhibitor LBH589 in Patients With Chemo-refractory Metastatic Gastric Cancer Overexpressing Histone Deacetylases (HDACs) - CLBH589BDE03T

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Gastric Cancer

Interventions

Type	Name	Description
DRUG	Panobinostat (LBH589)

Timeline

• Start date: 2009-06-01
• Primary completion: 2013-02-01
• First posted: 2012-02-08
• Last updated: 2013-05-01

Locations

2 sites across 1 country: Germany