CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
LBH589 (Panobinostat®)drug
Likely dose
LBH589 (Panobinostat®) 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01136499
NCT01136499Phase 2Completed
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Efficacy and Safety Assessment of Oral LBH589 in Adult Patients With Advanced Soft Tissue Sarcoma After Pre-treatment Failure: an Open-label, Multicenter Phase II Study

Centre Leon Berard·interventional·Posted Jun 3, 2010·Updated Mar 6, 2013

In Brief

A Phase 2 clinical trial evaluating LBH589 (Panobinostat®) for Soft Tissue Sarcoma. Completed, enrolled 53 participants across 1 site.

Detailed Summary

The purpose of this study is to assess efficacy and safety of LBH589 - Panobinostat®, a potent HDACi, in patients with advanced STS who experiment disease progression after or during first-line chemotherapy. The rational is based on the observation of activity of deacetylase inhibitor (DACi) in several pre-clinical models of STS including Synovial sarcoma and Ewing sarcoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSoft Tissue Sarcoma
CountriesFrance
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 3, 2010
Enrollment StartJan 1, 2010
Primary CompletionJan 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.1 years ago

Interventions

LBH589 (Panobinostat®)drug

40 mg MWF. 40 mg of LBH589, orally administered on Monday, Wednesday and Friday (MWF) on a weekly schedule, until tumor progression or unacceptable toxicity.