CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 53 enrolled
Drug / intervention
LBH589drug
Likely dose
Not stated in 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/NCT02717455
NCT02717455Phase 1Completed

Phase 1 Trial of Panobinostat in Children With Diffuse Intrinsic Pontine Glioma

Pediatric Brain Tumor Consortium·interventional·Posted Mar 23, 2016·Updated Apr 25, 2024

In Brief

A Phase 1 clinical trial evaluating LBH589 for Glioma. Completed, enrolled 53 participants across 10 sites.

Detailed Summary

This phase I trial studies the side effects and best dose of panobinostat in treating younger patients with diffuse intrinsic pontine glioma (DIPG). Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stratum 1 treats patients with DIPG that has returned or gotten worse (progressed). Stratum 2 treats patients with DIPG or H3K27+Thalamic Diffuse Malignant Glioma (DMG) that has not yet gotten worse.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioma
CountriesUnited States

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 23, 2016
Enrollment StartJun 28, 2016
Primary CompletionFeb 14, 2022
Study CompletionMar 31, 2024
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 10.3 years ago

Interventions

LBH589drug

STRATUM 1: Recurrent/progressive DIPG. Panobinostat will be given every other day, 3 times/ week, p.o. preferably on Mon/Wed/Fri, for three weeks, followed by one week off of therapy. Three weeks of therapy plus the one week rest period (4 weeks) will constitute one course. Treatment will continue for up to 26 courses (about 2 years) barring progressive disease or unacceptable toxicity. STRATUM 2: Non-progressed DIPG or H3K27M+ Thalamic DMG. Panobinostat will be given every other day, 3 times/week, every other week p.o. preferably on Mon/Wed/Fri. Four weeks will constitute one course. Treatment will continue for up to 26 courses (about 2 years) unless the patient experiences progressive disease, unacceptable toxicity or any of the off-treatment criteria.