CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
LBH589drug
Likely dose
LBH589 45 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/NCT00550277
NCT00550277Phase 2Completed
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A Phase II Study of LBH589 in the Treatment of Patients With Refractory Clear Cell Renal Carcinoma

SCRI Development Innovations, LLC·interventional·Posted Oct 29, 2007·Updated Nov 23, 2021

In Brief

A Phase 2 clinical trial evaluating LBH589 for Renal Cell Carcinoma. Completed, enrolled 20 participants across 10 sites.

Detailed Summary

Inhibition of histone deacetylase (HDAC) provides a novel approach for cancer treatment. LBH589, an oral HDAC inhibitor, has been well tolerated in phase I trials and has shown activity against several types of cancer. In this nonrandomized phase II trial, we are investigating the activity of LBH589 in the treatment of patients with refractory clear cell renal carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Carcinoma
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 29, 2007
Enrollment StartJan 1, 2008
Primary CompletionMar 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.7 years ago

Interventions

LBH589drug

LBHLBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring (Section 3.5.2), all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles.