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

NCT01528501 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2013-05-01

No results posted yet for this study

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

DRUG

Panobinostat (LBH589)

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Martina Mayr, Dr. · Klinikum rechts der Isar

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2013-02-28

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01528501 on ClinicalTrials.gov