At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 31 enrolled

Drug / intervention

Panobinostat +1 moredrug

Likely dose

Panobinostat 10 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/NCT00967044

NCT00967044Phase 2Completed

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Phase I/II of Panobinostat (LBH589) Plus Everolimus (RAD001) in Patients With Relapsed and Refractory Lymphoma

M.D. Anderson Cancer Center·interventional·Posted Aug 27, 2009·Updated Feb 26, 2015

In Brief

A Phase 2 clinical trial evaluating Panobinostat and Everolimus for Lymphoma. Completed, enrolled 31 participants across 1 site.

Detailed Summary

Objectives: Primary: * Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the novel combination of everolimus + Panobinostat (LBH589) in a phase-I study in patients with relapsed lymphoma (Hodgkin and non-Hodgkin). * Determine the safety and efficacy of this novel combination in a phase-II study in patients with relapsed Hodgkin and non-Hodgkin lymphoma Secondary: * Determine the in vivo effect of therapy on selected serum cytokines/chemokines (TGF-beta, thymus and activation-regulated chemokine (TARC), IL-6, IL-10, VEGF). * Examine pre-treatment level of selected molecular targets (HDACs 1-11, STAT6, pSTAT6, STAT3, pSTAT3, Myc, Akt, Pichia anomala killer toxin (pAkt), S6, pS6, p21, cyclin D1) in primary lymphoma cells and the surrounding reactive inflammatory cells obtained by core needle biopsies from patients with relapsed lymphoma. * Examine the correlation between molecular and biologic markers and clinical response and/or treatment-related toxicity.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsLymphoma

CountriesUnited States

CollaboratorsNovartis

Timeline

Phase 2CompletedFinished

20102011201220132014201520162017201820192020202120222023202420252026

First PostedAug 2009

Enrollment StartNov 2009

Primary CompletionMar 2014

TodayJul 2026

First PostedAug 27, 2009

Enrollment StartNov 1, 2009

Primary CompletionMar 1, 2014

TodayJul 2, 2026

Enrollment to primary: 4.3 yearsPosted 16.8 years ago

Interventions

Panobinostatdrug

Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week

Everolimusdrug

Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal.